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Ovarian, Cervical CancerOpen to EnrollmentPhase 3

ENDOMETRIAL: PRIOR-PLATINUM/IMMUNOTHERAPY: MK-2870-005

A Phase 3, 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)

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Study snapshot

Title
Merck MK-2870-005 Endometrial
Malignancy
Endometrial Cancer
Stage
Stage 3
Disease setting
Post-platinum/immunotherapy
Line of therapy
Post-immunotherapy
Investigational agent
Sacituzumab tirumotecan
Drug class
TROP-2 ADC
Principal investigator
Todd Tillmanns, MD
Sponsor
Merck Sharp and Dohme
Path
Carcinoma or carcinosarcoma
Randomized
Yes
ClinicalTrials.gov ID
NCT06132958

Eligibility and objectives

Key eligibility criteria details

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.

Objective

  • Primary
    • PFS
    • OS
  • Secondary
    • ORR
    • DOR
    • Safety

Treatment details