Study of Retifanlimab With Gemcitabine and Docetaxel for Treating Advanced or Unresectable Soft Tissue Sarcoma

What this Trial Is About

Researchers are evaluating Retifanlimab, an experimental monoclonal antibody targeting the PD-1 protein, combined with the chemotherapy drugs gemcitabine and docetaxel for treating advanced soft tissue sarcoma that cannot be removed by surgery. This study aims to assess the safety and effectiveness of this combination in patients with locally advanced or metastatic high-grade sarcoma. The trial is sponsored by Memorial Sloan Kettering Cancer Center and includes both Phase 1 and Phase 2 stages. The study begins with a safety run-in phase where patients receive standard doses of gemcitabine and docetaxel alongside Retifanlimab at various dose levels to find the recommended Phase 2 dose RP2D. After determining the RP2D, patients are assigned to one of five groups based on sarcoma type, receiving six cycles of gemcitabine and docetaxel with Retifanlimab added from the second cycle. Following this, Retifanlimab treatment continues until unacceptable side effects, disease progression, or up to 35 cycles about 105 weeks. Participants will have regular visits scheduled closely around treatment days for monitoring. Assessments include tumor measurements per RECIST v1.1 criteria and mandatory tumor biopsies at screening and during treatment if safe. Researchers will track safety, side effects, tumor response, and the proportion of patients free from disease progression at 24 weeks. The total study duration varies by participant, with ongoing monitoring during and after treatment cycles.

Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma