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

NCT04741438 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

  • Sarcoma

Interventions

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.

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741438 on ClinicalTrials.gov