OncoMatch/Clinical Trials/NCT06346197
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Is NCT06346197 recruiting? Yes, currently enrolling (Jun 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: HER2 (ERBB2) negative
HER2 negative
Required: PD-L1 (CD274) overexpression (CPS ≥ 5)
tumours express PD-L1 with a combined positive score (CPS) ≥ 5
Disease stage
Required: Stage III, IV
advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant or neoadjuvant chemotherapy allowed if ≥6 months since completion and recurrence
No prior treatment with chemotherapy for locally advanced/metastatic disease. 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 (without growth factor support within 14 d); Platelets ≥ 100 x 10^9/L (without transfusion for platelets within 7 d); Hemoglobin ≥ 9 g/dL (without 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
QT/QTc interval ≤ 450 msec for men and ≤ 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: Absolute neutrophil count ≥ 1.5 109/L (without growth factor support within 14 d) Platelets ≥ 100 109/L (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g/dL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL/min/1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration); QT/QTc interval longer than 450 msec for men and longer than 470 msec for women [excluded]; Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease [excluded].
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.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
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 qualifyRelated pages