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Brief Title: Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study
Official Title: Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study.
Study ID: NCT04095208
Brief Summary: This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.
Detailed Description: This multicenter, prospective, open-labeled 2-arm, randomized non-comparative phase II trial. This phase II trial is based on a 2-stage Simon's optimal design. Randomization 1:1 with 1 patient randomized in experimental arm A (association of nivolumab plus relatlimab) and 1 patient randomized in arm B (treatment by nivolumab alone).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Bergonié, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Institut de Cancérologie de l'Ouest - Site René Gauducheau, Nantes, , France
Hôpital Cochin, Paris, , France
Institut Gustave Roussy, Villejuif, , France