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

Sponsor: Gabriel Tinoco

Sponsor score: 0

ClinicalTrials ID:NCT06528769

Provider View

This clinical trial is testing a new treatment using a combination of ATRA and Cemiplimab to see if it can help control advanced leiomyosarcoma, a type of cancer that has spread or cannot be removed by surgery. The study aims to find out if this treatment is effective and safe for patients who have not responded to standard therapies.

Patient Parameters

Program Overview

The study is exploring whether a combination of two drugs, ATRA and Cemiplimab, can help treat patients with advanced leiomyosarcoma, a type of cancer that has spread or cannot be surgically removed. Patients will take ATRA by mouth for three days before each cycle of Cemiplimab, which is given through an IV every three weeks. The treatment will continue until the cancer progresses or side effects become too severe. The study will monitor how well the treatment works and its safety.

Description

The main goal of this study is to see if the combination of ATRA and Cemiplimab can effectively treat advanced leiomyosarcoma by measuring how much the tumors shrink. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates. The safety of the treatment will be assessed by monitoring any side effects.

Patients will take ATRA orally for three days before receiving Cemiplimab through an IV on the first day of each treatment cycle. Each cycle lasts 21 days, and the treatment will continue as long as it is effective and side effects are manageable. Patients will have regular check-ups, including scans and blood tests, to monitor their progress.

After completing the treatment, patients will have follow-up visits every 12-16 weeks to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed advanced or metastatic leiomyosarcoma that cannot be surgically removed.
  • Have at least one measurable tumor.
  • Have previously received standard chemotherapy for leiomyosarcoma.
  • May have had prior treatments targeting PD-1 or PD-L1, with a required break period before starting this study.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have adequate organ function based on specific blood test results.
  • Have a life expectancy of at least 6 months.
  • Be willing to follow study procedures and provide informed consent.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Be able to swallow pills.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Patients with hepatitis B or C must have controlled or cured infections.

Exclusion Criteria

  • Currently participating in another study or have recently received an investigational treatment.
  • Have active or a history of autoimmune diseases or immune deficiencies, with some exceptions for stable conditions.
  • Have a diagnosis of immunodeficiency or are taking high doses of steroids or other immunosuppressive drugs.
  • Have significant liver disease or cirrhosis.
  • Have untreated or symptomatic brain metastases.
  • Are pregnant or breastfeeding, or plan to become pregnant during or shortly after the study.
  • Have had severe side effects from previous checkpoint inhibitor treatments.
  • Have a history of lung diseases like pneumonitis.
  • Have significant heart disease or have had a major heart event recently.
  • Have had major surgery recently or need major surgery during the study.
  • Are taking antibiotics for an active infection.
  • Have had a stem cell or organ transplant.
  • Have received a live vaccine recently.
  • Are currently on antiviral therapy for hepatitis B.
  • Have had recent chemotherapy, immunotherapy, or radiation therapy.
  • Have severe allergies to study drugs or their components.
  • Have any condition that might interfere with the study or not be in the patient's best interest to participate.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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