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

NCT04551430 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-11-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Mia Weiss, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2027-02-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT04551430 on ClinicalTrials.gov