Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
441
Countries
1
Sites
1
solid tumour
The main objective of this pilot study is to explore the value of immune markers present in blood in the purpose of identifying biomarkers for immune-related toxicities of checkpoint inhibitors.
Key facts
- Sponsor
- Institut Jules Bordet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Aug 2022 → ongoing
- Decision date (initial)
- 2023-07-03
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Les amis de Bordet, Belgium · Fondation Lambeau-Marteaux, Belgium · FNRS Télévie, Belgium
External identifiers
- EU CT number
- 2023-505360-11-00
- EudraCT number
- 2021-000027-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety
The main objective of this pilot study is to explore the value of immune markers present in blood in the purpose of identifying biomarkers for immune-related
toxicities of checkpoint inhibitors.
Conditions and MedDRA coding
solid tumour
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-000027-12 | Immunological variables associated to ICI toxicity in cancer patients IRAES |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Age ≥ 18 years old
- ECOG performance status ≤ 1
- Must have histologically or cytologically confirmed solid tumour, eligible fortreatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
- All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
- Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration
- Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments
- Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments
- Completion of all necessary screening procedures within 14 days prior to enrolment
- Signed Informed Consent form (ICF) obtained prior to any study related procedure
Exclusion criteria 4
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
- Participation in another clinical trial
- Pregnant and/or lactating women
- Patients already receiving ICI
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 18
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 52000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Therapeutic indication, posology
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- posology
SUB29397 · Substance
- Active substance
- Ipilimumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 12 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1530 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15 mg/kg milligram(s)/kilogram
- Max total dose
- 15 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 85 mg milligram(s)
- Max total dose
- 2210 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Therapeutic indication,
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3466 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 6240 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254301 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB93452 · Substance
- Active substance
- Cabozantinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 14600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB178312 · Substance
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 20400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB189482 · Substance
- Active substance
- Cemiplimab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 350 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180078 · Substance
- Active substance
- Avelumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 20800 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARBOPLATINE MEDAC 10 mg/mL, solution à diluer pour perfusion
PRD10027338 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 12750 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 34009 550 922 6 1
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- population; posology; therapeutic ; indications ; treatment duration
SUB25427 · Substance
- Active substance
- Axitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 175 mg milligram(s)
- Max total dose
- 3045 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Therapeutic indication
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 8700 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176342 · Substance
- Active substance
- Durvalumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
SUB16451MIG · Substance
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 104 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 160 mg/ml milligram(s)/millilitre
- Max total dose
- 58400 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05332MIG · Substance
- Active substance
- Alizapride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 109500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07451MIG · Substance
- Active substance
- Cetirizine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 5475 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Jules Bordet
- Sponsor organisation
- Institut Jules Bordet
- Address
- Mijlenmeersstraat 90
- City
- Brussels
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- Institut Jules Bordet
- Contact name
- Clinical Trial Support Unit
Public contact point
- Organisation
- Institut Jules Bordet
- Contact name
- Clinical Trial Support Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 441 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-08-18 | 2022-08-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 35 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-505360-11-00_redacted | 1.3 |
| Protocol (for publication) | D1_Protocol_2023-505360-11-00_Redacted | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Atezolizumab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cemiplimab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Durvalumab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ipilimumab | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nivolumab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxaliplatin | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_summary_changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Avelumab | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Axitinib_EMA | Pfizer |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Bevacizumab | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cabozantinib | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin | TEVA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Etoposide | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Fluorouracil | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Nab_paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Pemetrexed | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_summary_changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_summary_changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_summary_changes | 1 |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_2023-505360-11-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_2023-505360-11-00_DE | 1.3 |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_2023-505360-11-00_FR | 1.3 |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_2023-505360-11-00_NL | 1.3 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-15 | Belgium | Acceptable 2023-05-25
|
2023-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-10 | Belgium | Acceptable 2023-11-23
|
2023-11-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-15 | Belgium | Acceptable 2024-06-28
|
2024-06-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-13 | Belgium | Acceptable 2025-04-22
|
2025-04-22 |