Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
143
Countries
2
Sites
8
Advanced cancer of the stomach or the gastroesophageal junction
To determine the objective response rate (ORR) of zolbetuximab as a single agent as assessed by an independent central reader.
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Aug 2018 → ongoing
- Decision date (initial)
- 2024-05-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511649-21-00
- EudraCT number
- 2017-002566-50
- ClinicalTrials.gov
- NCT03505320
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Others, Safety, Efficacy
To determine the objective response rate (ORR) of zolbetuximab as a single agent as assessed by an independent central reader.
Secondary objectives 6
- To evaluate the pharmacokinetics of zolbetuximab as a single agent, in combination with mFOLFOX6, in combination with pembrolizumab, in combination with mFOLFOX6 and nivolumab, and in combination with fluorouracil, leucovorin or folinic acid, oxaliplatin and docetaxel (FLOT)
- To evaluate pharmacokinetics of oxaliplatin and 5-FU in combination with zolbetuximab.
- To assess the safety and tolerability of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab), in combination with pembrolizumab, and in combination with FLOT
- To assess the immunogenicity of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab), in combination with pembrolizumab, and in combination with FLOT
- To evaluate health-related quality of life (HRQoL)
- To assess ORR of zolbetuximab in combination with pembrolizumab and in combination with mFOLFOX6 as assessed by an independent central reader
Conditions and MedDRA coding
Advanced cancer of the stomach or the gastroesophageal junction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10001150 | Adenocarcinoma gastric | 100000004864 |
| 21.1 | LLT | 10071114 | Metastatic gastric adenocarcinoma | 10029104 |
| 21.1 | LLT | 10066354 | Adenocarcinoma of the gastroesophageal junction | 10029104 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Pre-Screening After the pre-screening informed consent has been obtained, an archival tumor sample will be submitted for each subject to determine CLDN18.2 status (in addition to HER2 status for Cohorts 2 and 4 if required). If available, the most recent tumor sample is preferred. If archival tumor tissue is insufficient or unavailable for pre-screening, the subject will forego the pre screening period and directly enter the screening period and biopsy will be performed to obtain the tumor sample for eligibility needed to determine CLDN18.2 status and HER2 status as required. While not required for eligibility, programmed death-ligand 1 (PD-L1) status will be determined based on the tumor sample submitted.
|
Not Applicable | None | ||
| 2 | Screening and Enrollment Enrollment for Cohorts 1A, 2, 3A and 4A has been completed. Enrollment for Cohorts 4B and 5 is ongoing. After the screening main informed consent has been obtained, screening will take place up to 28 days prior to subject enrollment on cycle 1 day 1. Subjects may be rescreened once.
|
Not Applicable | None | ||
| 3 | Post-Treatment Follow-up Period for Disease Progression (Cohorts 1A, 2,and 4 only) If a subject discontinues all study treatment prior to disease progression, the subject will enter the post-treatment follow-up period and continue to undergo imaging assessments until disease progression or until the subject starts another anti-cancer treatment, whichever occurs first.
|
Not Applicable | None | ||
| 4 | Survival Follow-up Period (Cohorts 1A and 4B only) Following disease progression or the start of another anti-cancer therapy (whichever occurs first), subjects in Cohorts 1A and 4B will enter the survival follow-up period and be followed every 12 weeks. Survival follow-up will be performed via telephone
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Not applicable
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-000519-26 | A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Estudio fase 3 internacional, multicéntrico, doble ciego y aleatorizado, de la eficacia de zolbetuximab (IMAB362) más CAPOX, en comparación con placebo más CAPOX, como tratamiento de primera línea en sujetos con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado irresecable o metastásico, claudin (CLDN)18.2 positivo y HER2 negativo | |
| 2017-002567-17 | A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of IMAB362 Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Étude internationale de phase 3, multicentrique, randomisée, en double aveugle, comparant l’efficacité du traitement par IMAB362 plus mFOLFOX6 par rapport à un traitement par placebo plus mFOLFOX6 en première ligne chez des patients présentant un adénocarcinome de l’estomac ou de la jonction œsogastrique (JOG) Claudine (CLDN)18.2-positif, HER2-négatif, localement avancé inopérable ou métastatique , Estudio de fase 3 internacional, multicéntrico, doble ciego y aleatorizado, de la eficacia de IMAB362 más mFOLFOX6, en comparación con placebo más mFOLFOX6, como tratamiento de primera línea en sujetos con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado irresecable o metastásico, claudin (CLDN)18.2 positivo y HER2 negativo., Studio di Fase 3, Globale, Multicentrico, in Doppio Cieco, Randomizzato Volto a Valutare l’Efficacia di Zolbetuximab (IMAB362) più mFOLFOX6 rispetto a Placebo più mFOLFOX6 come Prima Linea di Trattamento in Soggetti con Adenocarcinoma Gastrico o della Giunzione Gastro-Esofagea (GGE) Metastatico o Localmente Avanzato Non Operabile Positivo per Claudin (CLDN) 18.2 e HER2-negativo. | |
| 2018-002551-15 | A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma , Étude randomisée de phase II, en ouvert, visant à évaluer l'activité antitumorale et la sécurité du zolbétuximab (IMAB362) en association au nab-paclitaxel et à la gemcitabine (nab-p + GEM) en première ligne de traitement de l'adénocarcinome du pancréas métastatique exprimant la claudine 18.2 (CLDN18.2), Étude randomisée de phase II, en ouvert, visant à évaluer l'activité antitumorale et la sécurité du zolbétuximab (IMAB362) en association au nab-paclitaxel et à la gemcitabine (nab-p + GEM) en première ligne de traitement de l'adénocarcinome du pancréas métastatique exprimant la claudine 18.2 (CLDN18.2), Estudio en fase II, aleatorizado y abierto para evaluar la actividad antitumoral y la seguridad de zolbetuximab (IMAB362) en combinación con nab paclitaxel y gemcitabina (Nab-P + GEM) como tratamiento de primera línea en pacientes con adenocarcinoma de páncreas metastásico con presencia de claudina-18.2 (CLDN18.2), Studio di fase 2, in aperto, randomizzato, volto a valutare l'attività antitumorale e la sicurezza di zolbetuximab (IMAB362) in combinazione con nab-paclitaxel e gemcitabina (Nab-P + GEM) come trattamento di prima linea in soggetti con adenocarcinoma pancreatico metastatico con positività a Claudina 18.2 (CLDN18.2), Studio di fase 2, in aperto, randomizzato, volto a valutare l'attività antitumorale e la sicurezza di zolbetuximab (IMAB362) in combinazione con nab-paclitaxel e gemcitabina (Nab-P + GEM) come trattamento di prima linea in soggetti con adenocarcinoma pancreatico metastatico con positività a Claudina 18.2 (CLDN18.2), Studio di fase 2, in aperto, randomizzato, volto a valutare l'attività antitumorale e la sicurezza di zolbetuximab (IMAB362) in combinazione con nab-paclitaxel e gemcitabina (Nab-P + GEM) come trattamento di prima linea in soggetti con adenocarcinoma pancreatico metastatico con positività a Claudina 18.2 (CLDN18.2) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Subject is considered an adult according to local regulation at the time of signing informed consent.
- Female subject is eligible to participate if she is not pregnant [See Appendix 12.6 Contraception Requirements] and at least one of the following conditions applies: a. Not a woman of child-bearing potential (WOCBP) as defined in Appendix 12.6 Contraception Requirements OR b. WOCBP who agrees to follow the contraceptive guidance as defined in Appendix 12.6 Contraception Requirements throughout the treatment period and for at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study drugs
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- Female subject must agree not to donate ova starting at screening and throughout the study, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study drugs.
- A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception as detailed in Appendix 12.6 Contraception Requirements during the treatment period and for at least 6 months after the final study drug administration.
- Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
- Subject has histologically confirmed gastric or GEJ adenocarcinoma.
- Cohorts 1-4: Subject has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
- Subject's tumor sample has CLDN18.2 expression, demonstrating moderate to strong membranous staining as determined by central IHC testing.
- Subject agrees not to participate in another interventional study while on treatment.
- Subject has ECOG performance status 0 to 1.
- Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.
- Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to the first dose of study treatment. In case of multiple central laboratory data within this period, the most recent data should be used. - Hemoglobin (Hgb) ≥ 9 g/dL (transfusion is allowed, but posttransfusion Hgb [24 hours or later following transfusion] must be ≥ 9 g/dL) - Absolute neutrophil count (ANC) ≥ 1.5 × 109/L - Platelets ≥ 100 × 109/L - Albumin ≥ 2.5 g/dL - Total bilirubin ≤ 1.5 × upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN in subjects without liver metastases (≤ 5 × ULN if liver metastases are present) - Cohorts 1-4: Estimated creatinine clearance ≥ 30 mL/min - Cohort 5: Serum creatinine <1.5 × ULN, or estimated creatinine clearance > 50 mL/min for subjects with serum creatinine levels > 1.5 × ULN - Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × ULN (except for subjects receiving anticoagulation therapy)
Exclusion criteria 17
- Subject has had prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies
- Subject has known immediate or delayed hypersensitivity or contraindication to any component of study treatment.
- Subject has received other investigational agents or devices concurrently or within 28 days prior to first dose of study treatment.
- Subject has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.
- Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
- Per investigator judgment, subject has significant gastric bleeding and/or untreated gastric ulcers that would preclude the subject from participation per investigator judgment.
- Subject has history of active central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
- Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements. - For subjects who are negative for HBs Ag, but HBc Ab positive, an HB DNA test will be performed and if positive the subject will be excluded. - Subjects with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible. - Subjects treated for HCV with undetectable viral load results are eligible.
- Subject has had within 6 months prior to first dose of study treatment any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
- Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study treatment.
- Subject has active autoimmune disease that has required systemic treatment within the past 3 months prior to the start of study treatment.
- Subject has a clinically significant disease or co-morbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the subject unsuitable for study participation.
- Subject has psychiatric illness or social situations that would preclude study compliance per investigator's judgment.
- Subject has had a major surgical procedure less or equal to 28 days before start of study treatment.
- Subject is without complete recovery from a major surgical procedure less or equal to 14 days before start of study treatment.
- Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma less or equal to 14 days (Cohorts 1 and 3A) and less or equal to 28 days (Cohorts 2 and 4A or 4B) prior to start of study treatment and has NOT recovered from any related toxicity.
- Subject has another malignancy for which treatment is required, per investigator's clinical judgment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ORR of Zolbetuximab as a single agent by independent review central reader
Secondary endpoints 14
- Pharmacokinetics of zolbetuximab (Cohorts 1A, 2, 3A, 4 and 5): AUCinf, AUCinf[%extrap], AUClast, AUCtau, Cmax, Ctrough, tmax, t1/2, tlast,CL, Vz, as appropriate
- Pharmacokinetics of oxaliplatin (Cohort 2) and 5-FU (Cohort 2): AUCinf, AUCinf[%extrap], AUClast, Cmax, tmax, t1/2, tlast,CL, Vz, as appropriate
- Safety and tolerability of single agent zolbetuximab, in combination with mFOLFOX6 (with or without nivolumab), in combination with pembrolizumab, and in combination with FLOT evaluated by AEs, ECG, vital signs, ECOG performance status and laboratory assessments (NCICTCAE version 4.03)
- Safety and tolerability of zolbetuximab + FLOT in Cohort 5 include the following additional assessments: surgical complications, surgical mortality as defined by death within 30 days of surgery, percentage of subjects able to complete preoperative chemotherapy, perioperative mortality and morbidity at 30 days and 90 days post last dose, percentage of subjects able to start postoperative chemotherapy, percentage of subjects able to complete postoperative chemotherapy
- Immunogenicity of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab), in combination with pembrolizumab and in combination with FLOT as measured by the frequency of anti-drug antibody (ADA) positive subjects
- HHRQoL measured by the QLQ-C30, OG-25, GP, EuroQOL Five Dimensions Questionnaire (EQ-5D) and the HRU questionnaires
- ORR of zolbetuximab in combination with pembrolizumab and in combination with mFOLFOX6 as assessed by an independent central reader
- ORR of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab) and in combination with pembrolizumab by investigator assessment
- DCR, DOR and PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab) and in combination with pembrolizumab as assessed by an independent central reader
- DCR, DOR and PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without nivolumab) and in combination with pembrolizumab as assessed by the investigator
- OS of zolbetuximab as a single agent, in combination with mFOLFOX6 and nivolumab, and in combination with FLOT
- Cohort 5 only: Antitumor activity of zolbetuximab and FLOT as measured by radiological response (restaging) and pathological response ypTNM (pCR)
- Cohort 5 only: DFS
- Cohort 5 only: Minimal residual disease and disease recurrence as measured by circulating tumor DNA (ctDNA)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
Calcium Folinate 10 mg/ml Injection
PRD1173964 · Product
- Active substance
- Folinic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- PL 04515/0069
- MA holder
- HOSPIRA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Hospira 5 mg/ml concentrate for solution for infusion
PRD4433823 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 85 mg/m2 milligram(s)/square meter
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- PL 04515/0215
- MA holder
- HOSPIRA UK LIMITED,WALTON OAKS
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil 50mg/ml Injection.
PRD4730727 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- PL 04515/0088
- MA holder
- HOSPIRA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD6183485 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- commercial configuration-product over-labeled at primary and secondary packaging level (vial and carton)
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941372 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- commercial configuration-product over-labeled at primary and secondary packaging level (vial and carton)
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- commercial configuration-product over-labeled at primary and secondary packaging level (vial and carton)
PRD11142563 · Product
- Active substance
- Zolbetuximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 800 mg/m2 milligram(s)/square meter
- Max total dose
- 800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/803
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 2375 Waterview Drive
- City
- Northbrook
- Postcode
- 60062-6111
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | E-data capture |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Other |
| Cmic Inc. ORG-100048084
|
Hoffman Estates, United States | E-data capture |
| Shin Nippon Biomedical Laboratories Ltd. ORG-100020905
|
Kainan, Japan | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Laboratory analysis, Code 5 |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Almac Clinical Services (Ireland) Limited ORG-100033336
|
Dundalk, Ireland | Other |
| Quest Diagnostics Nichols Institute Inc. ORG-100012789
|
San Juan Capistrano, United States | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 10, Other, Data management |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Laboratory analysis |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Greenfield, United States | Other |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 5 |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 24 | 4 |
| Italy | Ongoing, recruitment ended | 24 | 4 |
| Rest of world
Taiwan, Japan, Korea, Republic of, United States
|
— | 95 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
33002: Service d’Oncologie hématologi, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Regional Et Universitaire De Brest
33001: cancérologie et d'hématologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Bordeaux
33003, Avenue Du Haut Leveque, 33600, Pessac
Assistance Publique Hopitaux De Paris
33004: Cardiologie 2, 20 Rue Leblanc, 75015, Paris
Istituto Europeo Di Oncologia S.r.l.
39005: Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero Universitaria Pisana
39003: Oncologia 2, Via Paradisa 2, 56124, Pisa
Istituto Oncologico Veneto
39004: Oncologia Medica 3, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
39002: UOC Oncologia Medica, Piazza Luigi Miraglia 2, 80138, Naples
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 |
|---|---|---|---|---|---|
| France | 2018-10-10 | 2018-10-10 | 2024-09-11 | ||
| Italy | 2018-08-01 | 2018-08-01 | 2024-10-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_0101_Protocol_ 2024-511649-21_fp | 9.0 |
| Recruitment arrangements (for publication) | K1_FRA ICF patient recruitment procedure placeholder English 8951-CL-0103 | NA |
| Recruitment arrangements (for publication) | K1_ITA Recruitment arrangements Placeholder English 8951-CL-0103 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French 8951-CL-0103 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Pregnant Partner French 8951-CL-0103 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Screening French 8951-CL-0103 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_ITA Assessment Report Part II 1 Italian 8951-CL-0103 Public | NA |
| Subject information and informed consent form (for publication) | L1_ITA Assessment Report Part II 2 Italian 8951-CL-0103 Public | NA |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Italian 8951-CL-0103 Public | 7.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Patient Pregnancy Italian 8951-CL-0103 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Pregnant Partner Italian 8951-CL-0103 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Procedure Placeholder English 8951-CL-0103 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Screening Italian 8951-CL-0103 Public | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_0101_SmPC fluorouracil | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_0102_SmPC calciumfolinate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_0103_SmPC oxaliplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_0104_SmPC nivolumab | N/A |
| Synopsis of the protocol (for publication) | D2_0201_ProtocolSynopsis_FR_2024-511649-21_fp | 2.0 |
| Synopsis of the protocol (for publication) | D2_0202_ProtocolSynopsis_IT_2024-511649-21_fp | 2.0 |
| Synopsis of the protocol (for publication) | D2_0203_ProtocolSynopsis_EN_2024-511649-21_fp | 2.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-25 | Italy | Acceptable 2024-04-19
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | Italy | Acceptable 2024-09-23
|
2024-09-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-15 | Italy | Acceptable 2024-09-23
|
2024-11-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-19 | Italy | Acceptable 2025-03-10
|
2025-03-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-31 | Italy | Acceptable 2026-01-19
|
2026-01-21 |