Study on Targeted Treatments for Patients with Recurrent or Persistent Endometrial Cancer

Sponsor: Alliance Foundation Trials, LLC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04486352

Provider View

This clinical trial is exploring the safety and effectiveness of targeted treatments, with or without the immune therapy drug atezolizumab, for patients with endometrial cancer that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing new targeted treatments for patients with endometrial cancer that has come back or not responded to previous treatments. The study will use genetic testing to match patients with specific treatments based on their cancer's genetic profile. Some patients will receive a combination of targeted treatments and the immune therapy drug atezolizumab, while others will receive targeted treatments without atezolizumab. The study aims to find out how safe and effective these treatments are.

Description

This study is designed to test the safety and effectiveness of targeted treatments for patients with endometrial cancer that has returned or not responded to previous treatments. Participants will be grouped based on the genetic makeup of their cancer, which will be determined through genetic testing. Depending on their group, participants may receive a combination of targeted treatments with the immune therapy drug atezolizumab or targeted treatments without atezolizumab.

The study includes several groups, each testing different combinations of treatments. Some groups are already closed to new participants, while others are still open. Each group will have a set number of participants, and once that number is reached, the group will close unless more participants are needed for further research.

The study is flexible and may add new groups as it progresses, with approval from the study's Steering Committee. This allows researchers to explore additional treatment options as new information becomes available.

Eligibility Criteria

Inclusion Criteria

  • Have endometrial cancer that has returned or not responded after 1 or 2 previous treatments. Previous hormone treatments do not count towards this limit.
  • Have measurable cancer that can be tracked using standard criteria.
  • Provide a tumor sample for genetic testing, or have a previous genetic test result from within the last five years.
  • Have a life expectancy of more than 12 weeks.
  • Have recovered from recent treatments like radiation, surgery, or chemotherapy.

Exclusion Criteria

  • Have certain types of endometrial cancer, such as squamous carcinomas or sarcomas.
  • Have had another invasive cancer in the last 5 years, except for certain skin or breast cancers.
  • Have another primary invasive cancer, like ovarian or cervical cancer.
  • Have an active or past autoimmune disease or immune deficiency.
  • Have certain lung conditions or active lung infections.
  • Have active tuberculosis or severe infections within the last 4 weeks.
  • Have taken antibiotics for an infection within the last 2 weeks, except for preventive antibiotics.
  • Have significant heart disease.
  • Have received a live vaccine within the last 4 weeks or plan to during the study.
  • Have had a bone marrow or organ transplant.
  • Have used certain immune-stimulating or immune-suppressing medications recently.
  • Have untreated brain disease, uncontrolled seizures, or recent stroke.

AFT-50A Specific Exclusion Criteria:

  • Have had previous treatments with certain immune therapies, like CD137 agonists or anti-PD-1 therapies.

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