Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma
NCT05135845 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2023-02-03
Summary
Immunotherapy with anti-PD1 antibodies provides encouraging results on a subset of patients. Capmatinib, a MET inhibitor, has shown an imunomodulatory effect and a synergy with spartalizumab a PD-1 inhibitor. The purpose of this phase II trial is to evaluate the efficacy and safety of the combination of capmatinib + spartalizumab in adult patients with advanced oesogastric adenocarcinoma.
Conditions
- Oesophageal Adenocarcinoma
- Gastric Adenocarcinoma
Interventions
- DRUG
-
Capmatinib
Capmatinib 400mg BID for a maximum of 12 months or until progression, patient's refusal or unacceptable toxicity
- DRUG
-
Spartalizumab
Spartalizumab 300mg Q3W for a maximum of 12 months or until progression, patient's refusal or unacceptable toxicity
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-22
- Primary Completion
- 2023-04-30
- Completion
- 2025-10-31
Countries
- France
Study Locations
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