Pan tumor Roll Over Study

Start 5 May 2020 · Status Ongoing, recruiting · 10 EU/EEA countries · 65 sites · Protocol CA209-8TT

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 588

Countries 10

Sites 65

Pan tumor

The main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.

Key facts

Sponsor: Bristol-Myers Squibb Services Unlimited Company
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 5 May 2020 → ongoing
Decision date (initial): 2024-06-09
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Bristol-Myers Squibb International Corporation

External identifiers

EU CT number: 2023-506914-32-00
EudraCT number: 2018-004362-34
WHO UTN: U1111-1223-9508
ClinicalTrials.gov: NCT03899155

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.

Secondary objectives 2

To follow participants who have completed therapy and are in or have completed follow-up on a Parent Study investigating nivolumab or nivolumab combination therapy for long-term efficacy (including overall survival [OS])
Safety of cancer therapies used as comparator in Parent Studies

Conditions and MedDRA coding

Pan tumor

Version	Level	Code	Term	System organ class
20.0	LLT	10007050	Cancer	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Signed Written Informed Consent
Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
Participant is eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
Participant is on treatment hold in the Parent Study following longlasting response or are eligible for treatment rechallenge as defined in the Parent Study.

Exclusion criteria 10

For Participants planning to enter the study on nivolumab treatment: Participant is not eligible for study treatment per the Parent Study eligibility criteria
In the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptoms must have completely resolved and based on investigator assessment, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
Participants currently in other interventional trials, including those for coronavirus disease 2019 (COVID-19), may not participate in BMS clinical trials until the protocol-specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by the investigator
Participants not receiving clinical benefit as assessed by the Investigator
Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
History of allergy or hypersensitivity to study drug components
Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and BMS approval is required
Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation
Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the participant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).

Secondary endpoints 2

OS defined as date of randomization, first dose, or as defined in the Parent Study until date of death from any cause or censored on the last known alive date in the rollover study
Incidence of AEs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 98

Rucaparib

SUB74859 · Substance

Active substance: Rucaparib
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rubraca 300 mg film-coated tablets

PRD10480798 · Product

Active substance: Rucaparib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XK03 — -
Marketing authorisation: EU/1/17/1250/003
MA holder: PHARMAAND GMBH
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rucaparib

SUB74859 · Substance

Active substance: Rucaparib
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rubraca 250 mg film-coated tablets

PRD10480795 · Product

Active substance: Rucaparib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XK03 — -
Marketing authorisation: EU/1/17/1250/002
MA holder: PHARMAAND GMBH
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rucaparib

SUB74859 · Substance

Active substance: Rucaparib
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rubraca 200 mg film-coated tablets

PRD10480579 · Product

Active substance: Rucaparib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XK03 — -
Marketing authorisation: EU/1/17/1250/001
MA holder: PHARMAAND GMBH
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALIMTA 500 mg powder for concentrate for solution for infusion

PRD291536 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/04/290/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALIMTA 100 mg powder for concentrate for solution for infusion

PRD290939 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/04/290/002
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed

SUB09655MIG · Substance

Active substance: Pemetrexed
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/sq. meter
Max total dose: 9999 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed

SUB09655MIG · Substance

Active substance: Pemetrexed
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

YERVOY 5 mg/ml concentrate for solution for infusion

PRD9751787 · Product

Active substance: Ipilimumab
Substance synonyms: BMS734016, HLX13, IBI310
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FX04 — -
Marketing authorisation: EU/1/11/698/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

YERVOY 5 mg/ml concentrate for solution for infusion

PRD9751295 · Product

Active substance: Ipilimumab
Substance synonyms: BMS734016, HLX13, IBI310
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FX04 — -
Marketing authorisation: EU/1/11/698/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD9754356 · Product

Active substance: Nivolumab
Substance synonyms: BMS936558, ABP 206
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FF01 — -
Marketing authorisation: EU/1/15/1014/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The commercial bulk product (unlabelled vials) is packaged, labelled, and released (batch certification) at sites identified in the sIMPD for use in clinical studies.

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD9754364 · Product

Active substance: Nivolumab
Substance synonyms: BMS936558, ABP 206
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FF01 — -
Marketing authorisation: EU/1/15/1014/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The commercial bulk product (unlabelled vials) is packaged, labelled, and released (batch certification) at sites identified in the sIMPD for use in clinical studies.

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323786 · Product

Active substance: Pembrolizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FF02 — -
Marketing authorisation: EU/1/15/1024/002
MA holder: MERCK SHARP & DOHME B.V.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pembrolizumab

SUB167136 · Substance

Active substance: Pembrolizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD345289 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/001
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD345303 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/012
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD3441411 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/025
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD3436601 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/019
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD3440105 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/024
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD3436605 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/021
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD345292 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/007
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD345304 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/016
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD3441417 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/027
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD345306 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/018
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD345291 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/003
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD3440099 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/022
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD345300 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/006
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 150 mg film-coated tablets

PRD345298 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/004
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine

SUB12474MIG · Substance

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD345297 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/015
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 500 mg film-coated tablets

PRD345295 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/013
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine

SUB12474MIG · Substance

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD345301 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/010
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine Accord 300 mg film-coated tablets

PRD345294 · Product

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC06 — CAPECITABINE
Marketing authorisation: EU/1/12/762/009
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine

SUB12474MIG · Substance

Active substance: Capecitabine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 25 mg hard capsules

PRD505627 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/002
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 37.5 mg hard capsules

PRD505753 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/008
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sunitinib

SUB22321 · Substance

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 12.5 mg hard capsules

PRD505831 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: OTHER USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/001
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sunitinib

SUB22321 · Substance

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 25 mg hard capsules

PRD505838 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/005
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 12.5 mg hard capsules

PRD505881 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/004
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 50 mg hard capsules

PRD505944 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/003
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sunitinib

SUB22321 · Substance

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 37.5 mg hard capsules

PRD505633 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/007
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sunitinib

SUB22321 · Substance

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sutent 50 mg hard capsules

PRD505800 · Product

Active substance: Sunitinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX01 — -
Marketing authorisation: EU/1/06/347/006
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daratumumab

SUB175772 · Substance

Active substance: Daratumumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

DARZALEX 20 mg/mL concentrate for solution for infusion

PRD4120953 · Product

Active substance: Daratumumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FC01 — -
Marketing authorisation: EU/1/16/1101/002
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

DARZALEX 20 mg/mL concentrate for solution for infusion

PRD4120951 · Product

Active substance: Daratumumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FC01 — -
Marketing authorisation: EU/1/16/1101/001
MA holder: JANSSEN-CILAG INTERNATIONAL NV
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Disodium Folinate

SUB20566 · Substance

Active substance: Disodium Folinate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/sq. meter
Max total dose: 9999 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sodiofolin 50 mg/ml, solution for injection/infusion

PRD459779 · Product

Active substance: Disodium Folinate
Substance synonyms: SODIUM FOLINATE
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: V03AF06 — SODIUM FOLINATE
Marketing authorisation: PL: 11587/0005
MA holder: MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Relatlimab

PRD11223463 · Product

Active substance: Relatlimab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Relatlimab

PRD11507329 · Product

Active substance: Relatlimab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SOLUTION FOR INFUSION
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Xtandi 40 mg soft capsules

PRD9961946 · Product

Active substance: Enzalutamide
Substance synonyms: MDV3100
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L02BB04 — -
Marketing authorisation: EU/1/13/846/001
MA holder: ASTELLAS PHARMA EUROPE B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enzalutamide

SUB77412 · Substance

Active substance: Enzalutamide
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Oxaliplatin

SUB09490MIG · Substance

Active substance: Oxaliplatin
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Oxaliplatin 5 mg/ml concentrate for solution for infusion

PRD11958096 · Product

Active substance: Oxaliplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XA03 — OXALIPLATIN
Marketing authorisation: PA 2059/049/001
MA holder: FRESENIUS KABI DEUTSCHLAND GMBH
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bevacizumab

SUB16402MIG · Substance

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD389578 · Product

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FG01 — -
Marketing authorisation: EU/1/04/300/001
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bevacizumab

SUB16402MIG · Substance

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Avastin 25 mg/ml concentrate for solution for infusion.

PRD389577 · Product

Active substance: Bevacizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/kg milligram(s)/kilogram
Max total dose: 9999 mg/kg milligram(s)/kilogram
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01FG01 — -
Marketing authorisation: EU/1/04/300/002
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Nivolumab/Relatlimab

PRD9854659 · Product

Active substance: Nivolumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: UNKNOWN USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Not Authorised
MA holder: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation: No
Orphan designation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 5 mg hard capsules

PRD983686 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/013
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 250 mg hard capsules

PRD983660 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/023
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 140 mg hard capsules

PRD983659 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/020
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 250 mg hard capsules

PRD983653 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/024
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 100 mg hard capsules

PRD983652 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/018
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 5 mg hard capsules

PRD983692 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/014
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 180 mg hard capsules

PRD983654 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/022
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 100 mg hard capsules

PRD983693 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/017
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 20 mg hard capsules

PRD983657 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/015
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 20 mg hard capsules

PRD983655 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/016
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 180 mg hard capsules

PRD983695 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/021
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide

SUB10889MIG · Substance

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Temozolomide SUN 140 mg hard capsules

PRD983662 · Product

Active substance: Temozolomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01AX03 — TEMOZOLOMIDE
Marketing authorisation: EU/1/11/697/019
MA holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Stivarga 40 mg film-coated tablets

PRD3438600 · Product

Active substance: Regorafenib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XE21 — -
Marketing authorisation: EU/1/13/858/002
MA holder: BAYER AG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Stivarga 40 mg film-coated tablets

PRD3438601 · Product

Active substance: Regorafenib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01XE21 — -
Marketing authorisation: EU/1/13/858/001
MA holder: BAYER AG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Regorafenib

SUB73090 · Substance

Active substance: Regorafenib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CABOMETYX 40 mg film-coated tablets

PRD4382851 · Product

Active substance: Cabozantinib
Substance synonyms: XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX07 — -
Marketing authorisation: EU/1/16/1136/004
MA holder: IPSEN PHARMA
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CABOMETYX 20 mg film-coated tablets

PRD4382804 · Product

Active substance: Cabozantinib
Substance synonyms: XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EX07 — -
Marketing authorisation: EU/1/16/1136/002
MA holder: IPSEN PHARMA
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cabozantinib

SUB93452 · Substance

Active substance: Cabozantinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cabozantinib

SUB93452 · Substance

Active substance: Cabozantinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fluorouracil

SUB07721MIG · Substance

Active substance: Fluorouracil
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fluorouracil 50 mg/ml Solution for Injection or Infusion

PRD8600084 · Product

Active substance: Fluorouracil
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 9999 mg/m2 milligram(s)/square meter
Max total dose: 9999 mg/m2 milligram(s)/square meter
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01BC02 — FLUOROURACIL
Marketing authorisation: PL 20075/0078
MA holder: ACCORD HEALTHCARE LIMITED
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trametinib

SUB119776 · Substance

Active substance: Trametinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mekinist 0.5 mg film-coated tablets

PRD4361604 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/001
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mekinist 2 mg film-coated tablets

PRD4361606 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/005
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trametinib

SUB119776 · Substance

Active substance: Trametinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mekinist 2 mg film-coated tablets

PRD4361607 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/006
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mekinist 0.5 mg film-coated tablets

PRD4361605 · Product

Active substance: Trametinib
Substance synonyms: GSK1120212B
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 9999 mg milligram(s)
Max total dose: 9999 mg milligram(s)
Max treatment duration: 9999 Week(s)
Authorisation status: Authorised
ATC code: L01EE01 — -
Marketing authorisation: EU/1/14/931/002
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation: Bristol-Myers Squibb Services Unlimited Company
Address: Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
City: Dublin 15
Postcode: D15 T867
Country: Ireland

Scientific contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Public contact point

Organisation: Bristol-Myers Squibb Services Unlimited Company
Contact name: GSM-CT

Third parties 3

Organisation	City, country	Duties
Icon Laboratory Services Inc. ORG-100037135	Farmingdale, United States	Other
Syneos Health Inc. ORG-100008382	Morrisville, United States	On site monitoring, Code 12, Other, Code 8
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other

Locations

10 EU/EEA countries · 65 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruiting	2	2
Belgium	Ongoing, recruiting	6	1
Czechia	Ongoing, recruiting	1	1
France	Ongoing, recruiting	36	11
Germany	Ongoing, recruiting	34	9
Greece	Ongoing, recruiting	3	5
Italy	Ongoing, recruiting	37	9
Poland	Ongoing, recruiting	43	7
Romania	Ongoing, recruiting	77	5
Spain	Ongoing, recruiting	68	15
Rest of world Mexico, United States, Taiwan, Turkey, Puerto Rico, Argentina, Canada, Australia, Korea, Republic of, Japan, New Zealand, Chile, Israel, Brazil, Hong Kong, Switzerland, China, United Kingdom	—	281	—

Investigational sites

Austria

2 sites · Ongoing, recruiting

Medical University Of Vienna

Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna

Ordensklinikum Linz GmbH

Urologie, Fadingerstrasse 1, 4020, Linz

Belgium

1 site · Ongoing, recruiting

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur

Department of Medicine, Division of Pulmonology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir

Czechia

1 site · Ongoing, recruiting

Fakultni Nemocnice Hradec Kralove

Department of Oncology and Radiotherapy, Sokolska 581, 500 03, Novy Hradec Kralove

France

11 sites · Ongoing, recruiting

Centre Hospitalier Universitaire Grenoble Alpes

Dermatologie, Allergologie et Photobiologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Institut Gustave Roussy

Departement de Dermatologie, 114 Rue Edouard Vaillant, 94800, Villejuif

Centre Hospitalier Lyon Sud

Departement de Dermatologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite

Centre Hospitalier Universitaire De Saint Etienne

N/A, Avenue Albert Raimond, 42270, Saint Priest En Jarez

Centre Jean Perrin

Service d Oncologie, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1

Centre Hospitalier Regional De Marseille

Service de Dermatologie – Pavillon 4, 264 Rue Saint Pierre, 13005, Marseille

Centre Hospitalier Universitaire De Lille

Clinique Dermatologique, Rue Michel Polonowski, 59000, Lille

Centr Georges Francois Leclerc

Departement d Oncologie Medicale, 1 Rue Professeur Marion, 21000, Dijon

Centre Hospitalier Universitaire De Nantes

Service de Dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes

Centre Hospitalier Universitaire De Montpellier

Departement d Hematologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Hospital Foch

Service d’Oncologie Medicale, 40 Rue Worth, 92150, Suresnes

Germany

9 sites · Ongoing, recruiting

Universitaetsklinikum Tuebingen AöR

Hautklinik, Dermatologische Onkologie, Liebermeisterstrasse 25, Innenstadt, Tuebingen

KEM I Evang. Kliniken Essen-Mitte gGmbH

Onkologie, Henricistrasse 92, Huttrop, Essen

Thoraxklinik Heidelberg gGmbH

Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg

SRH Wald-Klinikum Gera GmbH

Zentrum fuer klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera

Universitaetsklinikum Jena KöR

Klinik und Poliklinik fuer Urologie, Am Klinikum 1, Lobeda, Jena

Medical Center - University Of Freiburg

Allgemeine Neurochirurgie, Breisacher Strasse 64, Stuehlinger, Freiburg Im Breisgau

SLK-Kliniken Heilbronn GmbH

Standort Fachklinik Loewenstein, Klinik fuer Thorakale Onkologie und Palliativmedizin, Geisshoelzle 62, Hirrweiler, Loewenstein

SLK-Kliniken Heilbronn GmbH

Klinik fuer Innere Medizin III, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn

Universitaetsklinikum Aachen AöR

Klinik und Poliklinik fuer Urologie, Pauwelsstrasse 30, 52074, Aachen

Greece

5 sites · Ongoing, recruiting

Thoracic General Hospital Of Athens I Sotiria

3rd Department of Internal Medicine, Oncology Unit, Messogion Avenue 152, 115 27, Athens

Laiko General Hospital Of Athens

First Department of Internal Medicine, Oncology Unit, Sevastoupoleos 16, 115 26, Athens

Alexandra Hospital

Oncology-Hematology Department, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens

Metropolitan Hospital

1st Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas

Athens Medical Center S.A.

Oncology Department, Pylea, Asklipiou 10, Thessaloniki

Italy

9 sites · Ongoing, recruiting

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Thoracic Oncology, Via Piero Maroncelli 40, 47014, Meldola

IRCCS Foundation Istituto Neurologico Carlo Besta

Neuro-Oncology, Via Giovanni Celoria 11, 20133, Milan

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Oncology, Via Cherasco 15, 10126, Turin

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Oncology, Via Mariano Semmola 52, 80131, Naples

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Oncology, Piazza Oms 1, 24127, Bergamo

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Oncology, Via Santa Sofia 78, 95123, Catania

Istituto Oncologico Veneto

Oncology, Via Gattamelata 64, 35128, Padova

Istituto Europeo Di Oncologia S.r.l.

Oncology, Via Giuseppe Ripamonti 435, 20141, Milan

I.F.O. Istituti Fisioterapici Ospitalieri

Oncology, Via Elio Chianesi N 53, 00144, Rome

Poland

7 sites · Ongoing, recruiting

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Klinika Onkologii, Ulica Szaserow 128, 04-141, Warsaw

Instytut Msf Sp. z o.o.

N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz

Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej

Osrodek Innowacyjnych Terapii, Ul. Terebelska 57/65, 21-500, Biala Podlaska

Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy

Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz

Copernicus Podmiot Leczniczy Sp. z o.o.

Oddzial Onkologii, Al. Zwyciestwa 31/32, 80-219, Gdansk

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Klinika Nowotworow Pluca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie

Oddzial onkologii z poddodzialem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn

Romania

5 sites · Ongoing, recruiting

Centrul De Oncologie SF Nectarie S.R.L.

Medical Oncology, Strada Caracal Nr 109, 200542, Craiova

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest

Sigmedical Services S.R.L.

Medical Oncology, Bis The Building Corp A, Strada Zamca Nr 21 Et 3, Suceava

Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca

Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca

Onco Clinic Consult S.A.

Medical Oncology, Strada Sararilor 28j, 200508, Craiova

Spain

15 sites · Ongoing, recruiting

Hospital Universitario Marques De Valdecilla

Oncology, Avenida Valdecilla Sn, 39008, Santander

Hospital Universitario Y Politecnico La Fe

Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Universitario Fundacion Jimenez Diaz

Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital General Universitario De Valencia

Oncology, Avenida Del Tres Cruces 2, 46014, Valencia

Clinica Universidad De Navarra

MEDICAL IMMUNOLOGY AND IMMUNOTHERAPY, Pio XII Etorbidea 36, 31008, Pamplona

Hospital Universitario Regional De Malaga

Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga

Hospital Universitario 12 De Octubre

Oncology, Bloque D, Avenida De Cordoba Sn, Madrid

Hospital Clinic De Barcelona

Oncology, Calle Rosellon 138, 08036, Barcelona

Hospital Universitari Vall D Hebron

Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Hospital Universitario La Paz

Oncology, Paseo De La Castellana 261, 28046, Madrid

Institut Catala D'oncologia

oncology, Carretera Canyet S/n, 08916, Badalona

Complexo Hospitalario Universitario De Santiago

Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela

Clinica Universidad De Navarra

MEDICAL IMMUNOLOGY AND IMMUNOTHERAPY, Calle Marquesado De Santa Marta 1, 28027, Madrid

Hospital Universitario Hm Sanchinarro

Oncology, Calle Ona 10, 28050, Madrid

Hospital De La Santa Creu I Sant Pau

Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Austria	2020-11-30	2020-11-30
Belgium	2021-03-17	2021-03-17
Czechia	2022-04-12	2022-04-12
France	2020-06-08	2020-06-08
Germany	2020-06-25	2020-06-25
Greece	2021-09-09	2021-09-09
Italy	2020-07-29	2020-07-29
Poland	2020-05-05	2020-05-05
Romania	2021-08-11	2021-08-11
Spain	2020-07-07	2020-07-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 166 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Admin Letter_2023-506914-32-00_redacted	03
Protocol (for publication)	D1_Protocol_EL_2023-506914-32-00_Redacted	AM 05
Protocol (for publication)	D1_Protocol_EN_2023-506914-32-00_Redacted	AM 05
Recruitment arrangements (for publication)	K1_Recruitment and Informed Consent Procedures Form	1.0
Recruitment arrangements (for publication)	K1_Recruitment and Informed Consent Procedures Form	1.0
Recruitment arrangements (for publication)	K1_Recruitment and Informed Consent Procedures_PL	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	3.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements_ES	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements_IT	1.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main_Ongoing patients_Redacted	12.2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partner_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Addendum_Ongoing patients_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Main_EN_Redacted	12.2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Main_RO_Redacted	12.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum ICF for treatment A_PL_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum ICF for treatment B_PL_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum ICF for treatment C_PL_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum ICF for treatment D_PL_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum ICF for treatment E_PL_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum Treatment Post PD_ENG_BE	2.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum_ IT_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum_PL_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_PL_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnancy_IT_Redacted	1.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_IT_Redacted	3.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Partner_PL_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Privacy Notice	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Specific for Treatment A_Nivolumab Monotherapy_redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Specific for Treatment E_Other Cancer Tx_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Specific for Treatment B_Nivo_ Ipi Supplemental_redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Specific for Treatment C_Rela_redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Specific for Treatment D_Nivo_ Other Cancer Therapies_redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_DUT_BE_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_EN_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_ESP_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_FRE_BE_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_GR_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum_RO_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_IT_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_Redacted	12.3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_DUT_BE_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_ENG_BE_Redacted	10.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_ESP_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_FRE_BE_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_GR_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_redacted	12.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner ICF_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_DUT_BE_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_EN_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_ESP_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_FRE_BE_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_GR_Redacted	2.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_Redacted	3.3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_RO_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Specific for Treatment A_Nivolumab Monotherapy_Ongoing patients_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Specific for Treatment E_Other Cancer Tx_Ongoing patients_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Specific for Treatment B_Nivo_Ipi Supplemental_Ongoing patients_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Specific for Treatment C_Rela_Ongoing patients_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Specific for Treatment D_Nivo_Other Cancer Therapies_Ongoing patients_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supp ICF A_IT_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supp ICF B_IT_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supp ICF C_IT_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supp ICF D_IT_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supp ICF E_IT_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF _Treatment C_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment A_EN_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment A_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment A_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment A_RO_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment B_EN_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment B_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment B_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment B_RO_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment C_EN_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment C_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment C_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment C_RO_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment D_EN_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment D_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment D_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment D_RO_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment E_EN_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment E_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment E_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_Treatment E_RO_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_TreatmentA_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Supplemental ICF_TreatmentD_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A Supplemental ICF_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A_ESP_Redacted	3.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A_Nivolumab Addendum_DUT_BE_Redacted	2.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A_Nivolumab Addendum_ENG_BE_Redacted	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A_Nivolumab Addendum_FRE_BE_Redacted	2.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment A_Nivolumab Supplemental ICF_GR_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B Supplemental ICF_Redacted	5.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B_ESP_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B_Nivo_ Ipi Addendum_DUT_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B_Nivo_ Ipi Addendum_ENG_BE_Redacted	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B_Nivo_ Ipi Addendum_FRE_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment B_Nivo_ Ipi Supplemental ICF_GR_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C Supplemental ICF_Redacted	6.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_ESP _Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_ESP_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_Rela_Nivo_ Addendum_DUT_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_Rela_Nivo_ Addendum_ENG_BE_Redacted	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_Rela_Nivo_ Addendum_FRE_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment C_Rela_Nivo_ Supplemental ICF_GR_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D Supplemental ICF_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D_ESP_Redacted	5.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D_Nivo_ Other Cancer Therapies Addendum_DUT_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D_Nivo_ Other Cancer Therapies Addendum_ENG_BE_Redacted	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D_Nivo_ Other Cancer Therapies Addendum_FRE_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment D_Nivo_ Other Cancer Therapies Supplemental ICF_GR_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E Supplemental ICF_Redacted	4.3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E_ESP	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E_Other Cancer Tx Addendum_DUT_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E_Other Cancer Tx Addendum_ENG_BE	1.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E_Other Cancer Tx Addendum_FRE_BE_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Treatment E_Other Cancer Tx Supplemental ICF_GR_Redacted	4.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_TreatmentA Supplemental ICF_Redacted	4.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_TreatmentA_ESP_Redacted	4.1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_TreatmentD Supplemental ICF_Redacted	6.2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_TreatmentD_ESP_Redacted	6.1.0
Subject information and informed consent form (for publication)	L1_SIS-ICF_Appendix 1_ongoing patients_Redacted	12.1.0
Subject information and informed consent form (for publication)	L1_SIS-ICF_Appendix 1_redacted	12.1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_GP Letter_IT	4.1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Reimbursement Procedures_IT	3.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Reimbursement request Form_IT	3.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Site specific contact list_for publication	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Bevacizumab_Avastin	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Bevacizumab_Avastin_highlighted changes	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Capecitabine_Accord	19
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Enzalutamide_Xtandi	26
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Fluorouracil_Accord	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Fluorouracil_Accord-RSI	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Leucovorin_Sodiofolin	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Oxaliplatin	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Oxaliplatin Compare	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Pembrolizumab_Keytruda	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Pemetrexed_Alimta	28
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Pemetrexed_Alimta Summary of Changes	28
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Regorafenib_Stivarga	21
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Sunitinib_Sutent	41
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Temozolomide_SUN	21
Summary of Product Characteristics (SmPC) (for publication)	E2_SMPC_Temozolomide_SUN Compare	21
Synopsis of the protocol (for publication)	D1_Protocol synopsis_AT_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_DUT_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_FRE_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_GER_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_CZ_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_EN_2023-506914-32-00	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ES_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_FR_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_GR_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_IT_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_PL_2023-506914-32-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_RO_2023-506914-32-00	1.0

Application history

8 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-04-29	Germany	Acceptable 2024-06-05	2024-06-05
2	SUBSTANTIAL MODIFICATION	SM-2	2024-09-12	Germany	Acceptable 2025-01-08	2025-01-08
3	SUBSTANTIAL MODIFICATION	SM-3	2025-04-04	Germany	Acceptable 2025-06-06	2025-06-06
4	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-07-16	Germany	Acceptable 2025-06-06	2025-07-16
5	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-07-18	Germany	Acceptable 2025-06-06	2025-07-18
6	SUBSTANTIAL MODIFICATION	SM-4	2025-09-15	Germany	Acceptable 2025-11-17	2025-11-18
7	SUBSTANTIAL MODIFICATION	SM-5	2025-12-19	Germany	Acceptable 2026-01-13	2026-01-13
8	NON SUBSTANTIAL MODIFICATION	NSM-4	2026-03-06	Germany	Acceptable 2026-01-13	2026-03-06