RecruitingPhase 3NCT06346197

Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

A Multicenter, Randomised, Comparative, Open-label Phase III 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)

Sponsor

Centre Leon Berard

Enrollment

132 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Metastatic Cancer Advanced Cancer MSI-H

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two immunotherapy drugs (immune checkpoint inhibitors) as a first-line treatment for a specific type of advanced stomach or esophageal cancer with a particular genetic marker. The cancer must have a feature called MSI-H or dMMR (meaning it has errors in how it repairs its DNA), which tends to respond well to immunotherapy. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer that is MSI-H/dMMR and HER2-negative - Your tumor's PD-L1 score (a measure of immune activity) is 5 or above - You have not yet received chemotherapy for your advanced disease (prior surgery-related chemo is allowed if it finished more than 6 months before recurrence) **You may NOT be eligible if...** - You have already been treated with chemotherapy for advanced or metastatic disease - Your cancer lacks the MSI-H/dMMR marker - Your tumor is HER2-positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBalstilimab

Balstilimab: 240mg, IV, Q2W, until disease progression, unacceptable toxicity, patient or investigator decision or up to 2 years.

DRUGBotensilimab

Botensilimab: 75mg, IV for up to 4 doses, Q6W until disease progression, unacceptable toxicity, patient or investigator decision or up to 2 years.

DRUGFolfox Protocol

oxaliplatin 85 mg/m2 , leucovorin 400 mg/m2 , and fluorouracil 400 mg/m2 administered IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours daily or per local standard on Days 1 and 2 of each treatment cycle, every 2 weeks.Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

DRUGXELOX

Oxaliplatin 130mg/m² IV on Day 1 of each treatment cycle + capecitabine 1000mg/m² orally twice daily on Days 1 to 14 of each treatment cycle, every 3 weeks. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

DRUGNivolumab

240mg, IV, Q2. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.