NCT04741438

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

A Randomised, Comparative, Prospective, Multicentre Study of the Efficacy of Nivolumab + Ipilimumab Versus Pazopanib Alone in Patients With Metastatic or Unresectable Advanced Sarcoma of Rare Subtype (RAR-Immune)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized open label, comparative, prospective, multicentre phase III study. The patients who meet the eligibility criteria will be randomly assigned (1:1) into one of the following treatments groups: * Experimental arm: Nivolumab + Ipilimumab (24 months maximum) * Control arm: Pazopanib alone (24 months maximum) A randomization procedure will be used to obtain a balanced distribution of stratifications factors: * The number of previous lines of treatment in advanced/metastatic setting: ≤1 line or \>1 line (a treatment line is defined as a treatment initiation whatever the reason) * The lymphocytes count at baseline: \<1 g/L or ≥1 g/L. After their eligibility has been confirmed, patients will be treated with: * The combination of Nivolumab + Ipilimumab for 4 cycles. After completion of 4 cycles with Ipilimumab, patients continue receiving nivolumab IV (480 mg Q4W) in the absence of disease progression or unacceptable toxicity. A cycle is defined as a 6-weeks period. * Or Pazopanib until disease progression or unacceptable toxicity. The planned treatment duration in both arm is maximum 24 months. After the completion of treatment, patients will be followed up within 30 days after the last study treatment administration. The survival and disease status will be updated for all patients at the time of the end of the study. The overall end of the study will be the Last Patient Last Visit (LPLV), defined as the End Of Treatment (EOT) visit of the last active patient.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Nivolumab and IPILIMUMAB	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.
DRUG	Pazopanib Oral Tablet [Votrient]	Treatment by pazopanib 800 mg/day per os, continuously during a maximum 24 months. In case of toxicity, dose will be delayed and reduced.

Timeline

• Start date: 2021-03-30
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2021-02-05
• Last updated: 2023-08-30

Locations

13 sites across 1 country: France