Study on Ipilimumab and Nivolumab Combination With or Without Cabozantinib for Adults with Advanced Soft Tissue Sarcoma

Sponsor: National Cancer Institute LAO

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05836571

Provider View

This clinical trial is testing whether combining the immunotherapy drugs ipilimumab and nivolumab with cabozantinib is more effective than using ipilimumab and nivolumab alone in treating advanced soft tissue sarcoma in adults.

Patient Parameters

Program Overview

This study is exploring the effects of combining two immunotherapy drugs, ipilimumab and nivolumab, with or without an additional drug called cabozantinib, in treating advanced soft tissue sarcoma. These drugs work by helping the immune system attack cancer cells and may also stop cancer cells from growing and spreading. The study aims to find out if adding cabozantinib to the treatment can better control the cancer compared to using ipilimumab and nivolumab alone.

Description

The main goal of this study is to see how long patients can live without their cancer getting worse when treated with ipilimumab and nivolumab, compared to when these drugs are combined with cabozantinib. Researchers will also look at how well the cancer responds to these treatments and whether adding cabozantinib makes a difference.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive nivolumab and ipilimumab through an IV drip every 21 days for four cycles, followed by nivolumab alone every 28 days. They will have regular scans and tests to monitor their cancer.

  • Group B: Patients will take cabozantinib pills daily and receive nivolumab and ipilimumab through an IV drip every 21 days for four cycles, followed by cabozantinib and nivolumab every 28 days. They will also have regular scans and tests.

Patients in Group A whose cancer progresses may switch to Group B to receive cabozantinib in addition to nivolumab.

Throughout the study, participants will undergo various tests, including CT or MRI scans, tumor biopsies, and blood and urine tests, to monitor their health and the treatment's effects. After completing the study treatment, patients will be followed up for 30 days.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced soft tissue sarcoma that cannot be surgically removed.
  • Must have at least one tumor that can be measured by scans or physical exam.
  • Must not have been treated with cabozantinib before, but previous treatment with other similar drugs is allowed.
  • Must be 18 years or older.
  • Must be in relatively good health, with a performance status score of 2 or less.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must not have high blood pressure that requires more than two medications to control.
  • Must agree to provide blood samples and undergo biopsies for research purposes.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after the last dose of the study drugs.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Must not have any unresolved side effects from previous cancer treatments, except for certain conditions like hair loss or stable thyroid issues.
  • Must not be taking any other investigational drugs or medications that could interfere with the study drugs.
  • Must not have a history of severe allergic reactions to similar drugs.
  • Must not have any significant medical conditions that could make participation unsafe.
  • Must not be pregnant or breastfeeding, as the study drugs could harm the baby.
  • Must not have had recent bleeding in the digestive tract or other specific medical issues within 12 weeks before starting the study.
  • Must be able to swallow tablets.
  • Must not require high doses of steroids or other immunosuppressive medications.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.