CIME - 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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506291-28-00

Acronym

CIME/ET23-185

Enrollment

132

Registered

2024-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with locally advanced/metastatic, MSI-H/dMMR gastric cancer

Brief summary

Overall Survival

Detailed description

PFS, Objective response rate after 16 weeks of treatment (ORR-16W) and duration of response (DoR) as per RECIST V1.1, Adverse events (AEs), drugs related AEs, drugs related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, immune-related AE graded according to NCI-CTCAE V5.0., Patient quality of life according to EORTC QLQC30 and items selected form the PRO CTC-AE, Translational program : TMB on tumor sample and ctDNA ; RNASeq and WES on pre and on-treatment tumor samples ; multi-IF or IHC (eg but not limited to PD-L1, TIGIT, LAG3, TIM3)

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGBOTENSILIMAB

DRUGFLUOROURACILE PFIZER 50 mg/mL

DRUGsolution à diluer pour perfusion

DRUGOXALIPLATINE WINTHROP 5 mg/ml

DRUGCAPECITABINE

DRUGBALSTILIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
PFS, Objective response rate after 16 weeks of treatment (ORR-16W) and duration of response (DoR) as per RECIST V1.1, Adverse events (AEs), drugs related AEs, drugs related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, immune-related AE graded according to NCI-CTCAE V5.0., Patient quality of life according to EORTC QLQC30 and items selected form the PRO CTC-AE, Translational program : TMB on tumor sample and ctDNA ; RNASeq and WES on pre and on-treatment tumor samples ; multi-IF or IHC (eg but not limited to PD-L1, TIGIT, LAG3, TIM3)	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026