Actively Recruiting
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Led by Gabriel Tinoco · Updated on 2025-09-30
16
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed metastatic or locally advanced unresectable leiomyosarcoma
- At least one measurable tumor lesion based on RECIST 1.1 criteria
- Prior treatment with standard chemotherapy with no limit on the number of therapies
- Prior PD-1 or PD-L1 therapies allowed with specified washout periods
- ECOG performance status between 0 and 2
- Adequate organ function including specific blood counts, kidney, liver function, and coagulation parameters
- Expected life expectancy of at least 6 months
- Willingness to comply with study procedures
- Negative pregnancy test within 14 days before first dose for women of childbearing potential
- Ability to understand and sign informed consent
- Ability to swallow and retain oral medication
- HIV patients with undetectable viral load on effective therapy are eligible
- Patients with controlled hepatitis B or cured hepatitis C are eligible
You will not qualify if you...
- Participation in another investigational therapy study or use of investigational device within 4 weeks before treatment
- Active or history of autoimmune diseases or immune deficiency with specific exceptions
- Use of systemic steroids or immunosuppressive therapy above specified doses within 14 days prior to treatment
- Severe liver cirrhosis or complications from cirrhosis
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 180 days after treatment
- Prior unacceptable toxicity to checkpoint inhibitor therapy
- Recent history of migraines requiring treatment
- History or evidence of pneumonitis or pulmonary fibrosis except certain radiation-related cases
- Significant cardiovascular disease within 6 months prior to treatment
- Major surgery within 8 weeks prior to treatment or planned during study
- Use of therapeutic antibiotics within 2 weeks prior to treatment
- Prior stem cell or organ transplantation
- Use of live attenuated vaccines within 4 weeks prior to and during study and 5 months after Cemiplimab
- Current antiviral treatment for hepatitis B
- Chemotherapy, immunotherapy, targeted therapy, or radiation within 2 weeks prior to treatment
- Severe allergic reactions to human antibodies
- Known allergies to Cemiplimab, ATRA, or related components
- Any condition or therapy that could interfere with study results or participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here