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.
Treatment: all-trans retinoic acid · Cemiplimab — A 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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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