Efficacy of the Combination of Nivolumab and Ipilimumab as a Treatment in Patients With Sarcoma of Rare Subtype

Sponsor
Centre Leon Berard
Study ID
NCT04741438
Phase
PHASE3
Status
Unknown

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • Nivolumab and IPILIMUMAB — DRUG
    The combination of Nivolumab+Ipilimumab will be given to patients as follows: * Nivolumab: 3 mg/kg IV over 30 minutes every 2 weeks for 4 cycles. * Ipilimumab 1 mg/kg IV over 60 minutes every 6 weeks for 4 cycles. After completion of 4 courses with ipilimumab, patients continue receiving nivolumab IV at the dose of 480 mg Q4W in the absence of disease progression or unacceptable toxicity for a maximum of 18 months. Nota Bene: A cycle is defined as a 6-weeks period. The planned treatment period is 24 months Nivolumab and Ipilimumab must be injected the same day every 6 weeks (Q6W). In case of toxicity, dose will be delayed, but will not be reduced.
  • Pazopanib Oral Tablet [Votrient] — DRUG
    Treatment by pazopanib 800 mg/day per os, continuously during a maximum 24 months. In case of toxicity, dose will be delayed and reduced.

Study Details

This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator. In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone. The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.

Key Dates

Start date
Mar 30, 2021
Status verified
Aug 2023
Primary completion
Feb 28, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Arm A (Experimental arm). * Nivolumab 3 mg/kg * Ipilimumab 1 mg/kg
  • Active Comparator: Arm B
    Arm B (Control arm). Pazopanib 800 mg/day

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: up to 36 months ]

Central Contacts

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