Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Status:
RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Gabriel Tinoco
Treatments:
cemiplimab Disulfides Immunoglobulin G Magnetic Resonance Spectroscopy Specimen Handling Tretinoin X-Rays