OncoMatch/Clinical Trials/NCT06346197
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Is NCT06346197 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for gastric cancer.
Treatment: Balstilimab · Botensilimab · Folfox Protocol · XELOX · Nivolumab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Gastric Cancer
Tumor Agnostic
Biomarker criteria
Required: MSH2 loss
Patient with MSI-H/dMMR
Required: MSH6 loss
Patient with MSI-H/dMMR
Required: MLH1 loss
Patient with MSI-H/dMMR
Required: PMS2 loss
Patient with MSI-H/dMMR
Required: HER2 (ERBB2) wild-type
HER2 negative
Required: PD-L1 (CD274) expression (CPS ≥ 5)
tumours express PD-L1 with a combined positive score (CPS) ≥ 5
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy for locally advanced/metastatic disease
Exception: adjuvant or neoadjuvant chemotherapy allowed if ≥6 months since completion and recurrence
No prior treatment with chemotherapy for locally advanced/metastatic disease. Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.
Cannot have received: anti-PD-1 therapy
Patients previously treated by anti-PD-1
Cannot have received: anti-PD-L1 therapy
Patients previously treated by anti-PD-L1
Cannot have received: anti-CTLA-4 therapy
Patients previously treated by anti-CTLA-4
Cannot have received: immunotherapy
Patients previously treated by any other immunotherapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9/L (no growth factor support within 14 d); Platelets ≥ 100 x 10^9/L (no transfusion within 7 d); Hemoglobin ≥ 9 g/dL (no transfusion within 7 d)
Kidney function
Creatinine clearance according to CKD-EPI ≥ 30 mL/min/1.73 m2
Liver function
Serum total bilirubin ≤ 1.5 x ULN (except Gilbert disease ≤ 3 x ULN); ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)
Cardiac function
No known prolongation QT/QTc interval (QT/QTc interval ≤ 450 msec for men, ≤ 470 msec for women); no clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease
Adequate hematologic and end-organ function, defined by the following laboratory test results: [see details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06346197 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for locally advanced/metastatic disease, anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify