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

Sarcoma Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sarcoma

• NCT number: NCT04741438
• Study type: Interventional
• Source: Centre Leon Berard
• Contact: Séverine METZGER
• Phone: +33(0)478782786
• Email: severine.metzger@lyon.unicancer.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2021
• Completion date: August 2025