Sarcoma Clinical Trial - Immunotherapy + Radiation in Resectable Soft

Status Active, not recruiting

Clinical Trial Summary

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Sarcoma

Clinical Trial Details

NCT number	NCT03463408
Study type	Interventional
Source	University of Rochester
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	July 17, 2018
Completion date	August 1, 2025

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