RecruitingPhase 1Phase 2NCT04577014

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

A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

98 participants

Start Date

Sep 29, 2020

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma Sarcoma Sarcoma,Soft Tissue Soft Tissue Sarcoma Adult

Summary

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining an immunotherapy drug called retifanlimab (an anti-PD-1 antibody) with two chemotherapy drugs (gemcitabine and docetaxel) is safe and effective for people with advanced soft tissue sarcoma — a type of cancer in the muscles, fat, or connective tissue — who have not yet received systemic treatment. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with metastatic or locally advanced, inoperable high-grade soft tissue sarcoma - You have not previously received systemic (whole-body) treatment for this cancer - You have at least one measurable tumor - You are in good general health (ECOG performance status 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have previously received chemotherapy or immunotherapy for this cancer - You have active autoimmune disease - You are pregnant or breastfeeding - You are on systemic corticosteroids or immunosuppressive drugs - You have active, uncontrolled hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRetifanlimab

Phase I: Dose Level 1 - 375 mg (flat dose) Dose Level 0 - 210 mg (flat dose) Dose Level -1 - 375 mg (flat dose) Dose Level -2 - 375 mg (flat dose) Phase II: 375 mg (flat dose)

DRUGGemcitabine

Phase I: Dose Level 1 - 900 mg/m2 Dose Level 0 - 900 mg/m2 Dose Level -1 - 750 mg/m2 Dose Level -2 - 675 mg/m2 The dose level with ≤ 1 DLT seen per patients will be declared the RP2D. Phase II: Participants will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab ) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles),

DRUGDocetaxel

Phase I: Dose Level 1 - 75 mg/m2 Dose Level 0 - 75 mg/m2 Dose Level -1 - 60 mg/m2 Dose Level -2 - 50 mg/m2 The dose level with ≤ 1 DLT seen per patients will be declared the RP2D. Phase II: Participants will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles),