Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04095208 | Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study | PHASE2 | COMPLETED | 68 | — | — | Feb 27, 2020 | Mar 29, 2026 | Apr 21, 2026 | 5 | France |
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
| Arm | Type | Description |
|---|---|---|
| Experimental: Randomized phase II trial - Arm A | EXPERIMENTAL | Combination of nivolumab and relatlimab. |
| Experimental: Randomized phase II trial - Arm B | EXPERIMENTAL | Treatment by nivolumab alone. |
| Name | Type | Description |
|---|---|---|
| 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) - \[240 mg\]. |
Inclusion Criteria: 1. Histology: participant with soft tissue sarcoma histologically confirmed and reviewed by the RRePS Network as recommended by the French NCI (Inca), 2. Presence of mature tertiary lymphoid structures (TLS). Except if presence of TLS have been already confirmed by Biopathologic...