A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Gabriel Tinoco
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.
Description
PRIMARY OBJECTIVES I. To determine the efficacy of the combination of ATRA and Cemiplimab in patients with metastatic/locally advanced -unresectable LMS by assessing objective response (ORR), Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune mediated Response Evaluation Criteria for Solid Tumors (iRECIST). SECONDARY OBJECTIVES I. To study the efficacy of the combination of ATRA and Cemiplimab in patients with advanced LMS, including progression-free survival (PFS), disease control rate (DCR), and overall survival (OS) based on modified RECIST version 1.1 and iRECI…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 and/or PD-L1 directed therapies are permitted. Minimal wash out period of 3 weeks for Pembrolizumab, Nivolumab , Durvalumab, 4 weeks for Ipilimumab. * ECOG performance status of 0-2. * Adequate organ function, as defined below. * Absolute neutrophil count (ANC) ≥ 1,500 /mcL, hemoglobin ≥9 g/dL (pat…
Interventions
- Drugall-trans retinoic acid
Given orally
- DrugCemiplimab
Given intravenously (IV)
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic resonance imaging
Undergo MRI
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio