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

Summary

Participation Requirements

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 (12 months maximum) Control arm: Pazopanib alon...

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 (12 months maximum) Control arm: Pazopanib alone (12 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 12 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.

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