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

Sponsor
Institut Bergonié
Study ID
NCT04095208
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Cancer
  • Soft Tissue Sarcoma Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Association of Nivolumab + Relatlimab — DRUG
    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) - \[80 mg\].
  • Nivolumab — DRUG
    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) - \[240 mg\].

Study Details

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

Key Dates

Start date
Feb 27, 2020
Status verified
Apr 2026
Primary completion
Sep 29, 2024
Completion
Mar 29, 2026

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Randomized phase II trial - Arm A
    Combination of nivolumab and relatlimab.
  • Experimental: Experimental: Randomized phase II trial - Arm B
    Treatment by nivolumab alone.

Primary Outcome Measure

Assessment of the antitumor activity of nivolumab in association with relatlimab independently for each arm [ Time Frame: 6 months ]

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