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

Part of paid clinical trials in Stanford, California.

Sponsor
Washington University School of Medicine
Study ID
NCT04551430
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Soft-tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 5, 2021
Status verified
Nov 2025
Primary completion
Feb 1, 2027
Completion
Feb 1, 2029

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Cabozantinib
    Patients randomized to Cohort A will take cabozantinib at a dose of 60 mg by mouth once each day of each 28-day cycle. Treatment may continue indefinitely. At time of progression, patients will continue on cabozantinib daily but will reduce their dose to 40 mg. They will cross over into Cohort B and initiate treatment.
  • Experimental: Cohort B: Cabozantinib + Nivolumab + Ipilimumab
    -Patients randomized to Cohort B will take cabozantinib at a dose of 40 mg by mouth once each day. Nivolumab will given IV at a dose of 3 mg/kg over approximately 30 minutes every 3 weeks for 4 doses, followed by 480 mg over approximately 30 minutes every 4 weeks until treatment discontinuation. Ipilimumab will be given IV at a dose of 1 mg/kg over approximately 30 minutes every 3 weeks for 4 doses. Treatment may continue for up to 2 years.
  • Experimental: Crossover from Cohort A to Cohort B: Cabozantinib + Nivolumab + Ipilimumab
    -Participants who cross-over from Cohort A into Cohort B will initiate treatment with nivolumab at a dose of 3 mg/kg IV over approximately 30 minutes and ipilimumab at a dose of 1 mg/kg IV over approximately 30 minutes. Nivolumab and ipilimumab will be given every 3 weeks for 4 doses. Nivolumab will then be continued at a dose of 480 mg IV over approximately 30 minutes every 4 weeks, with cabozantinib to continue at 40 mg every day. Treatment may continue for up to 2 years.

Primary Outcome Measure

Radiographic response rate by RECIST 1.1 [ Time Frame: From start of treatment until disease progression/recurrence or the date of subsequent therapy (estimated to be 24 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-
University of ColoradoAuroraColorado80045-
Washington University School of MedicineSt LouisMissouri63110-
Abramson Cancer Center at Pennsylvania HospitalPhiladelphiaPennsylvania19106-

Find similar trials in Stanford, CA

By research site
Stanford University Medical Center· Stanford, CAUniversity of Colorado· Aurora, COWashington University School of Medicine· St Louis, MOAbramson Cancer Center at Pennsylvania Hospital· Philadelphia, PA

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