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).
primary tumor cannot be safely removed surgically, or
primary tumor would benefit from systemic therapy prior to a surgical approach
Be willing and able to provide written informed consent
Must consent to mandatory tumor biopsy (if deemed safe and feasible) for research studies at screening, if archival tissue is not available, and at C1D15, C3D15.
Negative serum pregnancy test in women of childbearing potential
Patients with chronic HBV (HBsAg-positive with undetectable or low HBV DNA and normal ALT, or HBsAg-negative with anti-HBc-positive serology) and HCV (completed curative antiviral treatment with HCV viral load below the limit of quantification) may be eligible
Patients with HBV should be treated with suppressive antiviral therapy prior to enrollment
Patients with HCV must have completed curative therapy and have negative HCV viral load
Sequential
Retifanlimab
DrugPhase 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)
Gemcitabine
DrugPhase 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),
Docetaxel
DrugPhase 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),
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Treatment groupsSee each treatment group below.
Phase II: proportion of patients that are progression-free at 24 weeks by RECIST v1.1
The primary objective of the phase II portion of this study is to determine the proportion of patients that are progression-free at 24 weeks by RECIST v1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is \> -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Incyte Corporation
Collaborator
