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Retifanlimab with Chemotherapy for Advanced Soft Tissue Sarcoma

This study is testing a combination of drugs for people with advanced soft tissue sarcoma that cannot be removed by surgery. You may be able to join if you are 18 or older and have this type of sarcoma. The study uses two common chemotherapy drugs, gemcitabine and docetaxel, along with an experimental drug called Retifanlimab. Retifanlimab is an anti-PD-1 antibody, which means it's designed to help your immune system fight cancer. Researchers want to see if this combination is safe and effective, and if it can prevent the cancer from growing for at least 24 weeks. The study aims to enroll 98 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 98 participants to find the best dose of the drug combination and then test its effectiveness.
What's involved
Participants will receive Retifanlimab, gemcitabine, and docetaxel. You must be willing to provide written informed consent and consent to a mandatory tumor biopsy if needed.
Compensation
Not stated in the trial record.
Follow-up
The study will measure if your cancer has progressed at 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04577014

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~98 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:RetifanlimabGemcitabineDocetaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase II: proportion of patients that are progression-free at 24 weeks by RECIST v1.1
Measured over 24 weeks

Conditions

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

Explore related trials

Soft Tissue Sarcoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Sandra D'Angelo, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Sandra D'Angelo, MD
[email protected]
646-888-4159
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of metastatic or locally advanced and unresectable high-grade soft tissue sarcoma. Unresectable is defined as:
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 v1.1
Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.

Exclusion

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
Adequate organ function, as defined in Table 2:
Received any systemic therapy in the advanced or metastatic setting
Adjuvant or neoadjuvant therapies received ≥ 1 year prior to enrollment are permitted
Unstable or deteriorating cardiovascular disease within the previous 6 months, including:
Unstable angina or myocardial infarction
CVA/stroke
New York Heart Association \[NYHA\] Class III or IV congestive heart failure
Uncontrolled clinically significant arrhythmias
Current use of immunosuppressive medication, EXCEPT for the following:
Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Evidence of clinically significant immunosuppression such as the following:
Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
Concurrent opportunistic infection
Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 2 months prior to enrollment
History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.
Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease
Uncontrolled HIV infection, as defined by one or more of the following:
Patients with CD4+ T-cell (CD4+) counts \< 350 cells/uL
Patients with a history of an opportunistic infection secondary to AIDS
Patients on anti-microbials with drug-drug interactions with the study drugs on this protocol, who cannot be switched to alternative anti-microbials
Patients on antiretroviral therapy \< 4 weeks
Patients with HIV viral load \> 400 copies/mL
Active Hepatitis B or Hepatitis C
Patients who have received a live vaccine within 30 days of the start date of the planned study therapy (with the exception of COVID-19 vaccines)
History of active TB (Bacillus Tuberculosis)
Radiation therapy within 2 weeks prior to study day 1
If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Women who are pregnant or breast feeding
Patients expecting to conceive or father children within the projected duration of the trial, starting with the visit through 180 days after the last dose of study treatment(s)
Prior organ transplantation including allogenic stem-cell transplantation
Active infection requiring systemic therapy
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)
Patients with prior history of interstitial lung disease and clinically significant pulmonary compromise, including those who have a requirement for supplemental oxygen use to maintain adequate oxygenation

What this trial measures

  • Phase II: proportion of patients that are progression-free at 24 weeks by RECIST v1.124 weeks

    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.