Study on Cabozantinib and Dostarlimab for Recurrent Gynecologic Carcinosarcoma

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05559879

Provider View

This clinical trial is exploring a new treatment combination using Cabozantinib and Dostarlimab for patients with recurrent gynecologic carcinosarcoma. The study aims to see if this combination can improve treatment outcomes by targeting specific cancer growth factors and enhancing the immune response.

Patient Parameters

Program Overview

This study is testing a new treatment approach for recurrent gynecologic carcinosarcoma, a type of cancer that affects the female reproductive organs. The treatment combines two drugs: Cabozantinib, which blocks certain growth factors that help cancer cells grow, and Dostarlimab, an immunotherapy drug that helps the immune system attack cancer cells. Researchers hope that using these drugs together will be more effective than using them alone.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of carcinosarcoma, regardless of which gynecologic organ it originated from.
  • Have received at least one previous chemotherapy treatment for cancer.
  • Have a tumor that can be measured or evaluated by medical imaging.
  • Have recovered from any side effects of previous treatments to a mild level or baseline, unless they are not significant and stable with supportive care.
  • Have an ECOG performance status of 0 to 2, indicating full activity or some restriction in physically strenuous activity.
  • Be 18 years or older.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Be able to understand and agree to the study requirements and sign an informed consent form.
  • Women of childbearing potential must agree to use effective contraception during the study and for five months after the last treatment dose.
  • Women should not breastfeed while receiving treatment.
  • Women of childbearing potential must not be pregnant at the start of the study.

Exclusion Criteria

  • Have previously been treated with Cabozantinib.
  • Have taken any small molecule kinase inhibitors within two weeks or five half-lives before starting the study treatment.
  • Have received any other cancer treatments within four weeks before starting the study treatment.
  • Have had radiation therapy for bone metastasis within two weeks or any other radiation therapy within four weeks before starting the study treatment.
  • Have untreated or unstable brain metastases unless treated and stable for at least four weeks.
  • Are taking certain blood thinners that are not allowed in the study.
  • Have significant health issues, such as heart problems, uncontrolled high blood pressure, recent stroke, or serious bleeding issues.
  • Have gastrointestinal disorders that increase the risk of complications.
  • Have had major surgery within two weeks or minor surgery within ten days before starting the study treatment.
  • Have a prolonged QT interval on an ECG.
  • Cannot swallow tablets.
  • Have allergies to the study drugs.
  • Have been diagnosed with another cancer within the last two years, except for certain skin cancers or low-grade tumors.
  • Are receiving other cancer treatments.
  • Have serious chronic or acute illnesses that pose a high risk for the study treatment.
  • Have active infections or have received a live vaccine within 30 days before starting the study treatment.
  • Have certain lung diseases, autoimmune diseases, or require dialysis.
  • Have had a solid organ or stem cell transplant.

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