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Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Study Status Open To Accrual
National Clinical Trial Identifier NCT06132958
Phase III
  • Full Title

    A Phase III, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK- 2870-005/ENGOT-en23/GOG-3095)

  • Purpose
    The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of
    Physician's Choice (TPC) with respect to progression-free survival (PFS) per response
    evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central
    review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab
    tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and
    that sacituzumab tirumotecan is superior to TPC with respect to OS.
  • Eligibility
    The main inclusion and exclusion criteria include but are not limited to the following:

    Inclusion Criteria:

    - Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.

    - Has radiographically evaluable disease, either measurable or nonmeasurable per
    response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded
    independent central review (BICR).

    - Has received prior platinum-based chemotherapy and anti-programmed cell death 1
    protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately
    or in combination.

    Exclusion Criteria:

    - Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma,
    leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.

    - Has a history of documented severe dry eye syndrome, severe Meibomian gland disease
    and/or blepharitis, or corneal disease that prevents/delays corneal healing.

    - Has active inflammatory bowel disease requiring immunosuppressive medication or
    previous history of inflammatory bowel disease.

    - Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days
    after completing platinum-based therapy administered in the curative-intent or
    adjuvant setting without any additional platinum-based therapy received in the
    metastatic or recurrent setting.

    - Has received more than 3 prior lines of therapy for endometrial carcinoma or
    carcinosarcoma.
  • Resources & Links
  • Interested in this Trial?
    If you are interested in participating in this study, call The JamesLine at 800-293-5066 to make an appointment with the principal investigator listed or ask your doctor if you are eligible for this study.

Trial Information

Protocol Number:OSU-23428
Gender:Female
Disease Group:Gynecologic