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

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.

Trial Details

NCT ID
NCT06528769
Phase
PHASE2
Sponsor
Gabriel Tinoco
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • all-trans retinoic acid
  • Cemiplimab
  • Computed Tomography
  • Magnetic resonance imaging
  • Biospecimen Collection
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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