ATRA + Cemiplimab for Sarcoma

Recruiting in Palo Alto (17 mi)

Overseen byGabriel Tinoco, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gabriel Tinoco

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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

This trial is for patients with advanced leiomyosarcoma, a type of sarcoma, who have not responded to standard treatments. Participants must have metastatic or locally advanced disease that cannot be surgically removed.

Inclusion Criteria

Measurable disease based on RECIST 1.1. (At least one target lesion)

I am 18 years old or older.

Ability to understand and sign the informed consent document

+12 more

Exclusion Criteria

I have not received any vaccines within the prohibited time frame.

Presence of any condition, therapy, or abnormality that may interfere with trial results or patient participation

I have an autoimmune disease or immune deficiency, with some exceptions.

+16 more

Participant Groups

The study tests the combination of all-trans retinoic acid (ATRA) taken orally and Cemiplimab given intravenously in cycles. The effectiveness will be measured using imaging techniques like CT and MRI scans following a specific study design called BOP2.

1Treatment groups

Experimental Treatment

Group I: Treatment (all-trans retinoic acid [ATRA] and cemiplimab)Experimental Treatment5 Interventions

Patients recieve 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. Peripheral blood samples will be collected. Patients will undergo physical examination and imaging scans at baseline and then approximately every 6 weeks (2 cycles) for the first year of treatment and every 12 weeks thereafter

All-Trans Retinoic Acid (ATRA) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Vesanoid for: