Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGabriel Tinoco
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 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 criteria
Qualifiers
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.
Disqualifiers
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.
Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Rash must cover ≤ 10% of body surface area
Trial design
Treatments tested in this trial
- all-trans retinoic acid
- Cemiplimab
- Computed Tomography
- Magnetic resonance imaging
- Biospecimen Collection
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Gabriel Tinoco
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov