Phase 2 Study on the Effectiveness of DKN-01 and Pembrolizumab for Advanced or Recurrent Endometrial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05761951

Provider View

This clinical trial is testing whether a combination of two drugs, DKN-01 and pembrolizumab, can help control advanced or returning endometrial cancer. The study will also look at how well patients tolerate this treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if combining DKN-01 and pembrolizumab can effectively treat women with advanced or returning endometrial cancer. Researchers will measure how many patients respond to the treatment and how long they stay free from cancer progression. They will also assess the safety and side effects of the drug combination. Additionally, the study will explore how certain genetic factors might influence the treatment's effectiveness.

Description

This study is focused on women with advanced or recurrent endometrial cancer, a type of cancer that affects the lining of the uterus. The main goal is to see if the combination of DKN-01 and pembrolizumab can help shrink tumors or stop them from growing. Researchers will also look at how long patients live without the cancer getting worse and how long they survive overall.

The study will involve several tests to understand how the treatment works and if certain genetic markers in the cancer cells affect the response to the drugs. These tests will help determine if the treatment is more effective in patients with specific genetic changes.

Participants will need to provide a tumor sample before starting the treatment, and they must not have received certain other cancer treatments recently. The study will also monitor the participants' health and any side effects they experience during the trial.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with advanced or recurrent endometrial cancer that cannot be cured with surgery or radiation.
  • May have received up to two previous treatments for recurrent cancer.
  • Must provide a tumor sample for testing.
  • Must not have been treated with certain immune therapies before.
  • Must be in good general health with a performance status score of 0 to 2.
  • Women of childbearing potential must be surgically sterilized or postmenopausal for over 12 months.
  • Must have adequate blood, kidney, and liver function as shown by specific lab tests.

Exclusion Criteria

  • Have certain types of uterine cancer without specific genetic mutations.
  • Have received certain immune therapies before.
  • Have a history of certain genetic conditions that affect cancer treatment.
  • Have had other cancer treatments recently.
  • Have not recovered from side effects of previous cancer treatments.
  • Have had major surgery or a live vaccine recently.
  • Have certain immune system disorders or are taking high doses of steroids.
  • Have other active cancers or untreated brain metastases.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active infections or certain viral infections.
  • Have serious heart conditions or other medical issues that could interfere with the study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

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