Study aiming to compare the survival of patients with locally advanced or metastatic MSI/dMMR Esogastric adenocarcinomas treated by a combination of Immune checkpoint inhibitors (botensilimab + balstilimab) versus the standard of care (FOLFOX/XELOX + nivolumab)

2023-506291-28-00 Protocol CIME/ET23-185 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 2 Mar 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 9 sites · Protocol CIME/ET23-185

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 132
Countries 1
Sites 9

Patient with locally advanced/metastatic, MSI-H/dMMR gastric cancer

To compare the survival of patients under Botensilimab + Balstilimab versus the standard of care FOLFOX/XELOX + nivolumab

Key facts

Sponsor
Centre Leon Berard
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
Trial duration
2 Mar 2026 → ongoing
Decision date (initial)
2024-02-22
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Agenus Laboratory · PHRC interrégional

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To compare the survival of patients under Botensilimab + Balstilimab versus the standard of care FOLFOX/XELOX + nivolumab

Secondary objectives 4

  1. To further assess the clinical activity of the proposed combination
  2. To document the safety profile of the proposed combination
  3. To define the impact of the proposed combination on patient quality of life
  4. Translational program : To identify biomarkers predictive of tumor response

Conditions and MedDRA coding

Patient with locally advanced/metastatic, MSI-H/dMMR gastric cancer

VersionLevelCodeTermSystem organ class
21.1 PT 10017758 Gastric cancer 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Overal study period
From first patient in to last patient in
 Randomised Controlled None Experimental arm: Botensilimab: 75mg, IV for up to 4 doses, Q6W + Balstilimab: 240mg, IV, Q2W for up to 2 years
Standard arm: FOLFOX, IV, Q2W or Q3W + Nivolumab (360 mg, IV, Q3W ou 240mg, IV, Q2W). Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

  1. Male or female patient ≥18 years of age at time of informed consent form signature
  2. Patient with MSI-H/dMMR HER2 negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5
  3. Patient to be treated with a first line therapy for locally advanced/metastatic disease
  4. No prior treatment with chemotherapy for locally advanced/metastatic disease. Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have elapsed between completion of adjuvant chemotherapy and recurrence
  5. Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1
  6. Patient with PS ECOG 0 or 1
  7. Adequate hematologic and end-organ function, defined by the following laboratory test results (cf. protocol)
  8. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsable disease
  9. Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge
  10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through •9 months after the end of the treatment with oxaliplatin •6 months after the end of the treatment with fluorouracil •5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab •6 months for capecitabine Highly effective contraception is defined in appendix 03 of protocol
  11. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  12. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol
  13. Patients must be covered by a medical insurance

Exclusion criteria 23

  1. Oesogastric cancer eligible to treatment with curative intent
  2. Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy
  3. Patients with surgery or radiotherapy within less than 4 weeks before C1D1
  4. Patients with persistent AE Grade >1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.
  5. Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal
  6. Patients with known prolongation QT/QTc interval i.e. QT/QTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.
  7. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  8. Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.
  9. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  10. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
  11. History of allogeneic organ transplant.
  12. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  13. Patient with peripheral sensory neuropathy with functional impairment.
  14. Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.
  15. Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.
  16. Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/mL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng/ml and < 150 ng/mL)
  17. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
  18. Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.
  19. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
  20. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
  21. Patients with documented: Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1. Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or HIV infection
  22. Prior organ or bone marrow transplant.
  23. Pregnant or lactating women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall Survival

Secondary endpoints 4

  1. PFS, Objective response rate after 16 weeks of treatment (ORR-16W) and duration of response (DoR) as per RECIST V1.1
  2. Adverse events (AEs), drugs related AEs, drugs related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, immune-related AE graded according to NCI-CTCAE V5.0.
  3. Patient quality of life according to EORTC QLQC30 and items selected form the PRO CTC-AE
  4. Translational program : TMB on tumor sample and ctDNA ; RNASeq and WES on pre and on-treatment tumor samples ; multi-IF or IHC (eg but not limited to PD-L1, TIGIT, LAG3, TIM3)

Investigational products

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

Test 2

Balstilimab

PRD8723398 · Product

Active substance
Balstilimab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
240 mg milligram(s)
Max total dose
12480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Not Authorised
MA holder
AGENUS INC.
Paediatric formulation
No
Orphan designation
No

Botensilimab

PRD7271002 · Product

Active substance
Botensilimab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
75 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Not Authorised
MA holder
AGENUS INC.
Paediatric formulation
No
Orphan designation
No

Comparator 21

OXALIPLATINE WINTHROP 5 mg/ml, solution à diluer pour perfusion

PRD482101 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
85 mg/m2 milligram(s)/square meter
Max total dose
4420 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
34009 567 117 6 5
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

OXALIPLATINE WINTHROP 5 mg/ml, solution à diluer pour perfusion

PRD482340 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
85 mg/m2 milligram(s)/square meter
Max total dose
4420 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
34009 569 815 2 6
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

OXALIPLATINE WINTHROP 5 mg/ml, solution à diluer pour perfusion

PRD482347 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
85 mg/m2 milligram(s)/square meter
Max total dose
4420 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
34009 567 115 3 6
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
France
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
IV INFUSION
Max daily dose
360 mg milligram(s)
Max total dose
12480 mg milligram(s)
Max treatment duration
24 Month(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
No

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
IV INFUSION
Max daily dose
360 mg milligram(s)
Max total dose
12480 mg milligram(s)
Max treatment duration
24 Month(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
No

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD9332410 · Product

Active substance
Nivolumab
Substance synonyms
BMS936558, ABP 206
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
360 mg milligram(s)
Max total dose
12480 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF01 — -
Marketing authorisation
EU/1/15/1014/004
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

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
IV INFUSION
Max daily dose
360 mg milligram(s)
Max total dose
12480 mg milligram(s)
Max treatment duration
24 Month(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
No

Capecitabine

SCP131876 · ATC

Active substance
Capecitabine
Route of administration
ORAL USE
Max daily dose
1000 mg/m2 milligram(s)/square meter
Max total dose
24000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC06 — CAPECITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422649 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 572 533 4 9
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD9819807 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 550 902 2 9
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD495674 · Product

Active substance
Fluorouracil
Substance synonyms
5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 572 530 5 9
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422633 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 564 746 2 2
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD9819805 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 550 902 4 3
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422372 · Product

Active substance
Fluorouracil
Substance synonyms
5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 560 295 6 3
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD9819808 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 550 902 6 7
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422754 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 572 532 8 8
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD9819806 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 550 902 3 6
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422935 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 564 745 6 1
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD9819804 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 550 902 5 0
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD423054 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 572 531 1 0
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FLUOROURACILE PFIZER 50 mg/mL, solution à diluer pour perfusion

PRD422417 · Product

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
31200 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
34009 572 534 0 0
MA holder
PFIZER HOLDING FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Leon Berard

27 Total trials 17 Recruiting 9 Ended
Academic / Non-commercial
Sponsor organisation
Centre Leon Berard
Address
28 Rue Laennec
City
Lyon
Postcode
69008
Country
France

Scientific contact point

Organisation
Centre Leon Berard
Contact name
Medical oncology doctor

Public contact point

Organisation
Centre Leon Berard
Contact name
Project Manager

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 132 9
Rest of world — 0 —

Investigational sites

France

9 sites · Ongoing, recruiting
Centr Georges Francois Leclerc
Medical oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Paoli-Calmettes
Medical oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Francois Baclesse
Surgery, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Mutualiste Montsouris
Medical oncology, 42 Boulevard Jourdan, 75014, Paris
Hopital Prive Jean Mermoz
Gastroenterology and gastrintestinal oncology, 55 Avenue Jean Mermoz, 69008, Lyon
University Hospital Of Clermont-Ferrand
Digestive Oncology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Regional Et Universitaire De Brest
Digestive oncology, 2 Avenue Marechal Foch, 29200, Brest
Sainte Catherine Institut Du Cancer Avignon-Provence
Medical oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Hospitalier Universitaire De Poitiers
Gastroenterology and medical oncology, 2 Rue De La Miletrie, 86000, Poitiers

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2026-03-02 2026-03-02

Results and documents

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

Documents 15 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-506291-28-00 Final 4
Protocol (for publication) D1_Protocol 2023-506291-28-00 FP 6.0
Protocol (for publication) Questionnaire PRO-CTCAE -FR - only item highlighted 1
Protocol (for publication) Questionnaire QLQ-C30 version FR 1
Recruitment arrangements (for publication) Recruitment and Informed consent procedure template 1
Subject information and informed consent form (for publication) Carte Patient 1
Subject information and informed consent form (for publication) L1_SIS and ICF FP 4
Subject information and informed consent form (for publication) LivretSuiviEI 1
Subject information and informed consent form (for publication) Subject information and informed consent form PartenaireEnceinte 1
Subject information and informed consent form (for publication) Subject information and informed consent form Poursuite apres progression 1
Summary of Product Characteristics (SmPC) (for publication) Summary of product characteristics Capecitabine 1
Summary of Product Characteristics (SmPC) (for publication) Summary of product characteristics Fluorouracile 1
Summary of Product Characteristics (SmPC) (for publication) Summary of product characteristics Nivolumab 1
Summary of Product Characteristics (SmPC) (for publication) Summary of product characteristics Oxaliplatine 1
Synopsis of the protocol (for publication) D1_Protocol synopsis Final 5

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-10-31 France Acceptable
2024-02-22
 2024-02-22
2 SUBSTANTIAL MODIFICATION SM-1 2024-04-16 France Acceptable 2024-05-03
3 SUBSTANTIAL MODIFICATION SM-2 2025-07-29 France Acceptable
2025-10-17
 2025-10-22
4 SUBSTANTIAL MODIFICATION SM-3 2025-10-23 France Acceptable
2026-01-14
 2026-01-15
5 SUBSTANTIAL MODIFICATION SM-5 2026-01-21 France Acceptable
2026-03-18
 2026-03-20
6 NON SUBSTANTIAL MODIFICATION NSM-2 2026-04-29 France Acceptable
2026-03-18
 2026-04-29

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