Actively Recruiting
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-14
98
Participants Needed
1
Research Sites
313 weeks
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
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).
CONDITIONS
Official 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 and unresectable high-grade soft tissue sarcoma
- Willing and able to provide written informed consent
- Consent to mandatory tumor biopsy at screening and during treatment if safe and feasible
- Age 18 years or older
- ECOG performance status of 0 or 1
- Presence of measurable disease per RECIST v1.1 criteria
- No prior systemic therapy for advanced or metastatic disease (adjuvant/neoadjuvant therapy allowed if completed at least 1 year prior)
- Negative pregnancy test for women of childbearing potential
- Patients with controlled chronic HBV or HCV infection may be eligible
- Adequate organ function as defined by specific blood count, kidney, and liver function parameters
You will not qualify if you...
- Received systemic therapy for advanced or metastatic disease
- Unstable or worsening cardiovascular disease within past 6 months
- Current use of immunosuppressive medications except specified low-dose or local steroids
- Evidence of significant immunosuppression or primary immunodeficiency
- History or signs of symptomatic autoimmune disease in past 2 years (except replacement therapies)
- Uncontrolled HIV infection
- Active Hepatitis B or C infection
- Received live vaccine within 30 days prior to study therapy start (except COVID-19 vaccines)
- History of active tuberculosis
- Radiation therapy within 2 weeks before study start
- Incomplete recovery from major surgery toxicity or complications
- Pregnant or breastfeeding women
- Planning to conceive or father children during study and 180 days after last dose
- Prior organ transplantation including stem-cell transplant
- Active infection requiring systemic treatment
- Known severe hypersensitivity to study drugs or monoclonal antibodies
- History of interstitial lung disease or significant lung problems requiring supplemental oxygen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
W
William Tap, MD
CONTACT
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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