Actively Recruiting
A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-14
98
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic or locally advanced unresectable high-grade soft tissue sarcoma
- Willing and able to provide written informed consent
- Consent to mandatory tumor biopsies if safe and feasible
- Age 18 years or older
- ECOG performance status of 0 or 1
- Presence of measurable disease per RECIST v1.1
- No prior systemic therapy for advanced or metastatic sarcoma
- Negative pregnancy test in women of childbearing potential
- Adequate organ function as defined by blood counts, liver, and kidney tests
- Patients with controlled chronic HBV or successfully treated HCV may be eligible
You will not qualify if you...
- Received systemic therapy for advanced or metastatic sarcoma (except adjuvant/neoadjuvant therapy over 1 year prior)
- Unstable or worsening cardiovascular disease within past 6 months
- Current use of immunosuppressive medication except low-dose steroids or topical treatments
- Clinically significant immunosuppression or ongoing systemic immunosuppressive therapy
- History or evidence of symptomatic autoimmune disease in past 2 years
- Uncontrolled HIV infection or related complications
- Active hepatitis B or C infection
- Live vaccine within 30 days before starting study treatment (except COVID-19 vaccines)
- History of active tuberculosis
- Radiation therapy within 2 weeks prior to study start
- Recent major surgery without adequate recovery
- Pregnant or breastfeeding women
- Planning to conceive or father children during the trial and 180 days after
- Prior organ transplantation
- Active infection requiring systemic treatment
- Known severe hypersensitivity to study drugs or monoclonal antibodies
- History of interstitial lung disease or significant lung problems requiring oxygen use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive gemcitabine plus docetaxel at standard doses during cycle one, followed by addition of Retifanlimab starting cycle two for two cycles to evaluate safety and determine dosing.
Multiple visits corresponding to cycles 1 to 3 (every 3 weeks)
Duration - Up to 105 weeks
Participants are treated with the recommended phase 2 dose of gemcitabine/docetaxel for 6 cycles, with Retifanlimab added starting cycle 2. After 6 cycles, Retifanlimab continues alone until unacceptable toxicity, disease progression, or completion of 35 cycles.
Repeated visits every 3 weeks during chemotherapy cycles and Retifanlimab treatment
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
S
Sandra D'Angelo, MD
W
William Tap, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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