DESTINY-Endometrial01: Study on Trastuzumab Deruxtecan with Rilvegostomig or Pembrolizumab for First-Line Treatment of HER2-Positive Endometrial Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06989112

This clinical trial is testing new treatment combinations for patients with advanced or returning endometrial cancer that expresses HER2. The study compares the effectiveness of Trastuzumab Deruxtecan with either Rilvegostomig or Pembrolizumab against standard chemotherapy and Pembrolizumab.

Patient Parameters

Program Overview

The DESTINY-Endometrial01 study aims to find out if combining Trastuzumab Deruxtecan with Rilvegostomig or Pembrolizumab is more effective than the current standard treatment of chemotherapy and Pembrolizumab for patients with advanced or recurrent endometrial cancer that shows HER2 expression. The main focus is on how long patients live without the cancer getting worse.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of epithelial endometrial carcinoma (except sarcomas, but carcinosarcomas are allowed).
  • Have advanced (Stage III/IV) or first recurrent endometrial cancer after surgery or biopsy.
  • Cancer must show HER2 expression (3+ or 2+) and be mismatch repair proficient (pMMR).
  • Provide a tumor sample for testing.
  • Have not received first-line systemic anticancer therapy, except possibly one prior line of chemotherapy if the cancer returned 6 months after treatment.
  • Have not been treated with certain types of cancer drugs before.
  • May have had prior radiation therapy for endometrial cancer.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a heart function of at least 50%.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • History of organ transplant.
  • Have uncontrolled illnesses or active infections.
  • Have spinal cord compression or active brain metastases.
  • Have had a heart attack in the last 6 months or have serious heart conditions.
  • Have a history of lung disease that required steroids or current lung issues.
  • Have significant lung illnesses or autoimmune disorders affecting the lungs.
  • Have had a complete lung removal.
  • Have active autoimmune or inflammatory disorders needing chronic treatment.
  • Have active infections like tuberculosis, uncontrolled HIV, or hepatitis B or C (unless controlled with treatment).
  • Are receiving other cancer treatments without a proper break before starting the study.

Locations

FACILITYZIPCITYSTATE
Research Site85704TucsonArizona
Research Site72205Little RockArkansas
Research Site91010DuarteCalifornia
Research Site92037La JollaCalifornia
Research Site94304Palo AltoCalifornia
Research Site94143San FranciscoCalifornia
Research Site91342SylmarCalifornia
Research Site33901Fort MyersFlorida
Research Site33140Miami BeachFlorida
Research Site33705St. PetersburgFlorida

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