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

Recruiting Phase 3 Interventional Study
Gastric Cancer MSI-H Metastatic Cancer Advanced Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Centre Leon Berard · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female patient ≥18 years of age at time of informed consent form signature. * Patient with MSI-H/dMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS…
Contacts

Christelle DE LA FOUCHARDIERE, MD

04 91 22 35 03

delafouchardierec@ipc.unicancer.fr

CONTACT