Actively Recruiting
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Led by Centre Leon Berard · Updated on 2026-04-21
132
Participants Needed
6
Research Sites
127 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm).
CONDITIONS
Official Title
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older at the time of consent
- Diagnosis of MSI-H/dMMR, HER2-negative advanced or metastatic gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma with PD-L1 expression (CPS 65 5)
- Claudin 18.2 status known and documented before inclusion
- Planned first-line treatment for locally advanced or metastatic disease
- No prior chemotherapy for advanced or metastatic disease; prior adjuvant or neoadjuvant chemotherapy allowed if relapse occurred at least 6 months after completion
- Measurable disease with at least one lesion 65 10 mm by CT scan per RECIST V1.1
- ECOG performance status 0 or 1
- Adequate blood counts and organ function as defined by specified laboratory values
- Availability of a suitable tumor tissue sample meeting quality criteria
- Tumor lesion accessible for repeatable biopsy with core needle
- Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during and after treatment as specified
- Male patients with female partners of childbearing potential must agree to use effective contraception during and after treatment
- Ability and willingness to provide informed consent and comply with study procedures
- Medical insurance coverage
You will not qualify if you...
- Esogastric cancer eligible for curative intent treatment
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immunotherapy
- Surgery or radiotherapy within 4 weeks before first treatment dose
- Persistent adverse events greater than Grade 1 from prior cancer treatment except alopecia
- Low levels of potassium, magnesium, or calcium below normal
- Known prolonged QT/QTc interval beyond specified thresholds
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Other malignancies interfering with study or with less than 2 years disease-free
- Allergy or hypersensitivity to study drugs or excipients
- Interstitial lung disease or pneumonitis requiring glucocorticoids
- History of allogeneic organ transplant
- Psychiatric or substance abuse disorders affecting study cooperation
- Peripheral sensory neuropathy with functional impairment
- Significant active heart disease or recent myocardial infarction
- Recent or concurrent use of brivudine
- Complete or partial deficiency of dihydropyrimidine dehydrogenase (DPD)
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive medication near treatment start
- Live vaccine within 4 weeks before treatment start
- Active or recent autoimmune disease requiring systemic treatment
- Any condition or infection that may interfere with study participation or safety
- Active hepatitis B or C infection not controlled
- HIV infection
- Prior organ or bone marrow transplant
- Pregnant or breastfeeding women
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
CHU de Brest
Brest, France, 29000
Actively Recruiting
2
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
3
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
4
Institut Paoli Calmettes
Marseille, France, 13000
Actively Recruiting
5
Institut Mutualiste Montsouris
Paris, France, 75000
Actively Recruiting
6
CHU de Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
C
Christelle DE LA FOUCHARDIERE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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