A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of metastatic or locally advanced and unresectable high-grade soft tissue sarcoma. Unresectable is defined as: 1. primary tumor cannot be safely removed surgically, or 2. 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. * Age ≥ 18 years * ECOG performance status ≤ 1 * Presence of measurable disease per RECIST…
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),
Location
- Memorial Sloan Kettering Cancer CenterNew York, New York