Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

February 27, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Soft Tissue Sarcoma AdultAdvanced Cancer
Interventions
DRUG

Association of Nivolumab + Relatlimab

"A treatment cycle consists of 4 weeks.~Nivolumab will be administered as a 30-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - \[240 mg\].~Relatlimab will be administered as a 60-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - \[80 mg\]."

DRUG

Nivolumab

"A treatment cycle consists of 4 weeks.~Nivolumab will be administered as a 30-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - \[240 mg\]."

Trial Locations (5)

33000

Institut Bergonié, Bordeaux

44805

Institut de Cancérologie de l'Ouest - Site René Gauducheau, Nantes

69000

Centre Léon Bérard, Lyon

75014

Hôpital Cochin, Paris

94805

Institut Gustave Roussy, Villejuif

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Institut Bergonié

OTHER