Study

Overview

Official Title: 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)

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

710

Study Start Date:

December 2023

Estimated Study Completion Date:

January 2028

Estimated Primary Completion Date:

January 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

CRITERIA

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.

Locations

United States Toll Free Number 1-800-770-4674

Ponce, 00717
San Juan, 00909
San Juan, 00935
Mobile, Alabama, 36604
Washington, District of Columbia, 20010
Miami Beach, Florida, 33140
Columbus, Georgia, 31904
Fort Wayne, Indiana, 46845
Shreveport, Louisiana, 71103
Reno, Nevada, 89511
Mineola, New York, 11501
New York, New York, 10016
Germantown, Tennessee, 38138
Houston, Texas, 77030

Canada Study Coordinator 514-890-8000

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-2870-005

Study Detail

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