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OncoMatch/Clinical Trials/NCT06528769

Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma

Is NCT06528769 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including all-trans retinoic acid and Cemiplimab for leiomyosarcoma.

Phase 2RecruitingGabriel TinocoNCT06528769Data as of May 2026

Treatment: all-trans retinoic acid · CemiplimabA phase 2 study assessing the efficacy of all-trans retinoic acid (ATRA) and Cemiplimab in patients with metastatic/locally advanced - unresectable leiomyosarcoma (LMS) who have progressed standard-of-care therapy. Patients will be enrolled in cohorts according to a Bayesian Optimal Phase II design (BOP2). Study treatment will consist of ATRA at a starting dose of 150 mg/m2/day for 3 days orally prior to each cycle of Cemiplimab 350 mg IV q3 weeks for three cycles and then Cemiplimab monotherapy until the progress of disease or unacceptable toxicities develops.

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: cytotoxic chemotherapy

Patients must have received standard of care chemotherapy. No limits to prior lines of therapy.

Cannot have received: checkpoint inhibitor

Exception: Prior PD-1 and/or PD-L1 directed therapies are permitted.

Any patient who has experienced unacceptable toxicity on prior checkpoint inhibitor therapy as detailed below: 1. ≥ Grade 3 AE related to checkpoint inhibitor. 2. Ongoing ≥ Grade 2 immune-related AE associated with checkpoint inhibitor with the exception of endocrine toxicities as detailed below. 3. CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor. * NOTE: Patients with a prior or ongoing endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.

Cannot have received: investigational agent

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

Cannot have received: chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy

Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1

Cannot have received: allogeneic stem cell or solid organ transplantation

Prior allogeneic stem cell or solid organ transplantation

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1,500 /mcL, hemoglobin ≥9 g/dL (patients may be transfused to meet this criterion), lymphocytes ≥ 500/mcL, platelets ≥ 100,000/mcL.

Kidney function

Serum creatinine ≤ 1.5 X ULN or measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min for patients with creatinine levels > 1.5 X 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 X ULN. For patients with known Gilbert disease, serum bilirubin ≤ 3 X ULN. AST and ALT ≤ 2.5 X ULN or ≤ 5 X ULN for patients with liver metastases. Albumin ≥ 2.5 g/dL.

Adequate organ function, as defined below.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ohio State University Comprehensive Cancer Center · Columbus, Ohio

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