RecruitingPhase 2NCT06528769

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

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

Sponsor

Gabriel Tinoco

Enrollment

16 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Sarcoma Leiomyosarcoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — ATRA (all-trans retinoic acid, a derivative of vitamin A) and cemiplimab (an immunotherapy drug) — in patients with advanced leiomyosarcoma, a rare cancer of smooth muscle tissue that has spread or cannot be surgically removed. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with metastatic or locally advanced, inoperable leiomyosarcoma - Your cancer is measurable on scans - You have already received standard chemotherapy - You have not previously been treated with a PD-1/PD-L1 checkpoint inhibitor **You may NOT be eligible if...** - You have not received prior standard chemotherapy - You have previously been treated with a PD-1/PD-L1 immunotherapy drug - Your cancer is not measurable on imaging - You have serious other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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