NCT05135845

Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

Phase II Trial to Evaluate the Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-04-01
• Completion: 2025-10-01
• First posted: 2021-11-26
• Last updated: 2023-02-03

Locations

7 sites across 1 country: France