NCT04551430

Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma

A Randomized Phase II Trial of Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this study is that the response rate of soft tissue sarcoma will be improved with the addition of PD-1 and CTLA-4 inhibition to cabozantinib, and that cabozantinib priming will increase the response to nivolumab and ipilimumab.

Conditions

• Metastatic Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib will be supplied by Exelixis.
DRUG	Nivolumab	Nivolumab will be provided free of charge (as investigational supply) by Bristol-Myers Squibb.
DRUG	Ipilimumab	Ipilimumab will be provided free of charge (as investigational supply) by Bristol-Myers Squibb.

Timeline

• Start date: 2021-01-05
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2020-09-16
• Last updated: 2025-11-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study