General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06989112

Background Information

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

For more information visit: https://clinicaltrials.gov/study/NCT06989112

Offered At

8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Saveri Bhattacharya, DO

Eligibility Information

  • No prior chemotherapy for the treatment of EC, except for one prior line of adjuvant/ neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if completed ≥ 6 months prior to signature of the main ICF. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.
  • Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing.
  • Endometrial cancer that is determined pMMR by prospective central testing.
  • Provision of an adequate FFPE tumor tissue sample for central HER2, MMR, and PD-L1 IHC testing.
  • ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed)
  • Participant must have primary advanced disease (Stage III/IV) or recurrent endometrial cancer and meet at least one of the following criteria:
    • Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.
    • Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline.
    • Recurrent disease regardless of presence of measurable disease at baseline.

Ineligibility Information

  • Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol.
  • Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
  • History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis.
  • History of organ transplant or allogeneic stem cell transplant.
  • Spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases may be included in the study.