OncoMatch/Clinical Trials/NCT04577014
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
Is NCT04577014 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Retifanlimab and Gemcitabine for soft tissue sarcoma.
Treatment: Retifanlimab · Gemcitabine · Docetaxel — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Grade: high
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant or neoadjuvant therapies received ≥ 1 year prior to enrollment are permitted
Lab requirements
Blood counts
Absolute neutrophil count (ANC): ≥ 1,500 /mcL; Platelets: ≥ 75,000 / mcL; Hemoglobin: ≥ 9g/dL or ≥ 5.6 mmol/L
Kidney function
Serum creatinine: ≤ 1.5 X ULN OR Measured or calculated creatinine clearance: ≥ 60 mL/min for patient with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
Liver function
Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN except patients with Gilbert's disease (≤ 3x ULN); AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases
Adequate organ function, as defined in Table 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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