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

Recruiting Phase 2 Interventional Study
Leiomyosarcoma Sarcoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
16 (estimated)
Sponsor
Gabriel Tinoco · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Confirmed metastatic or locally advanced - unresectable Leiomyosarcoma (LMS) * Measurable disease based on RECIST 1.1. (At least one target lesion) * Patients must have received standard of care chemotherapy. No limits to prior lines of therapy. * Prior PD-1 an…
Contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066

OSUCCCClinicaltrials@osumc.edu

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