Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Sarcoma

Tertiary Lymphoid Structures

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Relatlimab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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) - \[80 mg\].

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) - \[240 mg\].

Antoine ITALIANO, MD, PhD

Simone MATHOULIN-PELISSIER, MD, PhD

Jean-Yves BLAY, MD, PhD

Emmanuelle BOMPAS, MD

Pascaline BOUDOU-ROUQUETTE, MD

Benjamin VERRET, MD

This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.

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).

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

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

Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), based on RECIST 1.1

Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1)

Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first

Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause)

GMI is defined for each patient as the ratio of its PFS on the nivolumab + relatlimab treatment combination to its PFS on the previous line of therapy (Von Hoff 1998)

Toxicity graded using the Common Terminology Criteria for Adverse Events version 5

Levels of cytokines in blood will be measured by ELISA

Levels of lymphocytes in blood will be measured by flow cytometry

Levels of kynurenine in blood will be measured by ELISA

Levels of immune cells in tumor will be measured by immunohistochemistry

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study	NCT04095208	Soft Tissue Sar... Advanced Cancer	Association of ... Nivolumab	18 Years -	Institut Bergonié
Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study	NCT04095208	Soft Tissue Sar... Advanced Cancer	Association of ... Nivolumab	18 Years -	Institut Bergonié

Spots Global Cancer Trial Database for association of nivolumab + relatlimab