Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
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).
Eligibility criteria
Qualifiers
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) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.
Patient to be treated with a first line therapy for locally advanced/metastatic disease.
No prior treatment with chemotherapy for locally advanced/metastatic disease.
Disqualifiers
Oesogastric cancer eligible to treatment with curative intent
Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy
Patients with surgery or radiotherapy within less than 4 weeks before C1D1
Patients with persistent AE Grade >1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.
Trial design
Treatments tested in this trial
- Balstilimab
- Botensilimab
- Folfox Protocol
- XELOX
- Nivolumab
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre Leon Berard
Lead sponsor
Agenus Inc.
Collaborator
Source ClinicalTrials.gov