Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT03463408
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

Study Details

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Key Dates

Start date
Jul 17, 2018
Status verified
Jul 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy arm
    Cohort A will comprise adult soft tissue sarcoma patents who consent to and receive ipilimumab + nivolumab concurrently with standard of care radiation. Ipilimumab will be given at a dose of 1 mg/kg every 6 weeks (total two doses) and nivolumab given as a flat dose of 240 mg every 2 weeks (total four doses). Standard surgical resection will be done 2 to 4 weeks after completion of radiotherapy. Accrual is expected to occur over 2 years. Follow up data will be collected for up to 3 years post-treatment.
  • No Intervention: no immunotherapy arm
    Cohort B will comprise patients eligible for the trial who do not wish to receive immunotherapy but consent to the same blood draws, surveys, and specimen analysis as Cohort A. Cohort B will serve as a non-randomized but pragmatic and clinically relevant control group. Standard surgical resection will be done 2 to 4 weeks after completion of radiotherapy. Accrual is expected to occur over 2 years. Follow up data will be collected for up to 3 years post-treatment.

Primary Outcome Measure

Adverse Event evaluation [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochesterNew York14642-0001-

Find similar trials in Rochester, NY

By research site
James P. Wilmot Cancer Center at University of Rochester Medical Center· Rochester, NY

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