NCT03463408

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Pilot Study of Neoadjuvant Dual Checkpoint Blockade With Concurrent Radiation in Resectable Soft Tissue Sarcoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Detailed description

A single institution two cohort, open label, non-randomized study of neoadjuvant nivolumab and ipilimumab with concurrent radiation followed by surgical resection. 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). 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. Peripheral blood will be collected on day 1 pre-treatment, day 14, day 42, immediately prior to surgery, and at 3 month follow up. Peripheral blood will be sent for multidimensional flow analysis of changes in immune cell composition and markers of proliferation. Serum samples will be obtained before starting treatment and after surgery. Samples from select subjects whose resected tumors show significant response and whose tumors showed minimal response will be sent to Serametrix for serum profiling to detect antibody response to a panel of tumor-specific antigens. 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	nivolumab	240 mg every 2 weeks
DRUG	ipilimumab	1 mg/kg every 6 weeks

Timeline

• Start date: 2018-07-17
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2018-03-13
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study