OncoMatch/Clinical Trials/NCT06346197
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Is NCT06346197 recruiting? Yes, currently enrolling (May 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
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.
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