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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

October 15, 2024

Primary Completion Date

May 15, 2028

Study Completion Date

May 15, 2028

Conditions
Gastric CancerMSI-HMetastatic CancerAdvanced Cancer
Interventions
DRUG

Balstilimab

Balstilimab: 240mg, IV, Q2W, until disease progression, unacceptable toxicity, patient or investigator decision or up to 2 years.

DRUG

Botensilimab

Botensilimab: 75mg, IV for up to 4 doses, Q6W until disease progression, unacceptable toxicity, patient or investigator decision or up to 2 years.

DRUG

Folfox Protocol

oxaliplatin 85 mg/m2 , leucovorin 400 mg/m2 , and fluorouracil 400 mg/m2 administered IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours daily or per local standard on Days 1 and 2 of each treatment cycle, every 2 weeks.Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

DRUG

XELOX

Oxaliplatin 130mg/m² IV on Day 1 of each treatment cycle + capecitabine 1000mg/m² orally twice daily on Days 1 to 14 of each treatment cycle, every 3 weeks. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

DRUG

Nivolumab

240mg, IV, Q2. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Trial Locations (1)

Unknown

Centre Léon Bérard, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

lead

Centre Leon Berard

OTHER