Phase II Study of Futibatinib and Pembrolizumab for Advanced Endometrial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05036681

Provider View

This clinical trial is exploring a new treatment combination of futibatinib and pembrolizumab for patients with advanced endometrial cancer that has spread and is not suitable for surgery or radiation. The study aims to find out if this combination is safe and effective in providing lasting responses.

Patient Parameters

Program Overview

The purpose of this study is to test a new combination of drugs, futibatinib and pembrolizumab, in patients with advanced endometrial cancer that is stable in its genetic makeup (microsatellite stable). Researchers want to see if this treatment can help control the cancer and if it is safe for patients to use.

Description

The main goals of this study are to see how well the combination of futibatinib and pembrolizumab works in shrinking tumors in patients with advanced endometrial cancer and to check for any side effects. Researchers will measure complete and partial responses to the treatment using standard criteria and will monitor any adverse effects according to established guidelines.

Participants must have advanced endometrial cancer that cannot be treated with surgery or radiation and must have already tried or declined at least one chemotherapy treatment. The cancer must be microsatellite stable, as confirmed by a certified lab. Participants need to have at least one tumor that can be measured by scans.

Eligible participants must be 18 years or older, able to take oral medications, and have adequate organ function as shown by specific blood tests. Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during and after the study.

Participants should not have had prior treatment with similar drugs (anti-PD-(L)1 therapy or FGFR inhibitors) and must be able to understand and agree to the study requirements. Any previous radiation treatment must have been completed at least two weeks before starting the study drugs, and participants must have recovered from any side effects.

Participants must provide a tissue sample from a previous biopsy or agree to a new biopsy if needed. They should not have any medical conditions that could interfere with the study or increase risks, such as uncontrolled infections, heart problems, or significant surgical recovery needs. Participants should not be taking other investigational drugs or have received certain treatments or vaccines recently.

Eligibility Criteria

Inclusion Criteria

  • Have advanced endometrial cancer that cannot be treated with surgery or radiation.
  • Have tried or declined at least one chemotherapy treatment.
  • Cancer must be microsatellite stable, confirmed by a certified lab.
  • Have at least one tumor that can be measured by scans.
  • Be 18 years or older.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Have adequate organ function as shown by specific blood tests.
  • Be able to take oral medications.
  • No prior treatment with similar drugs (anti-PD-(L)1 therapy or FGFR inhibitors).
  • Able to understand and agree to the study requirements.
  • Any previous radiation treatment must have been completed at least two weeks before starting the study drugs.
  • Provide a tissue sample from a previous biopsy or agree to a new biopsy if needed.

Exclusion Criteria

  • Have uncontrolled medical conditions, such as infections or heart problems.
  • Have not recovered from major surgery or significant injury.
  • Have unresolved side effects from previous treatments.
  • Cannot swallow oral medications.
  • Have active bleeding or ulcers.
  • Have a history of allergic reactions to the study drugs.
  • Are currently participating in another clinical trial or taking investigational drugs.
  • Have received certain treatments or vaccines recently.
  • Have uncontrolled brain tumors or require high doses of steroids.
  • Have another significant cancer requiring active treatment.
  • Are pregnant or breastfeeding.
  • Have known HIV or active hepatitis B or C infections.

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