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

Description

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

Conditions

Endometrial Cancer

Study Overview

Study Details

Study overview

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

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)

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

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Mobile

USA Mitchell Cancer Institute ( Site 4142), Mobile, Alabama, United States, 36604

Anchorage

Alaska Womens Cancer Care ( Site 4122), Anchorage, Alaska, United States, 99508

Phoenix

HonorHealth (HH) ( Site 8000), Phoenix, Arizona, United States, 85016

Tucson

Arizona Oncology Associates - HOPE ( Site 8002), Tucson, Arizona, United States, 85711

Los Angeles

UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc, Los Angeles, California, United States, 90095

San Francisco

California Pacific Medical Center - Van Ness Campus ( Site 4129), San Francisco, California, United States, 94109

New Haven

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114), New Haven, Connecticut, United States, 06511

Washington

MedStar Washington Hospital Center ( Site 4108), Washington, District of Columbia, United States, 20010

Miami Beach

Mount Sinai Cancer Center ( Site 4117), Miami Beach, Florida, United States, 33140

Orlando

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113), Orlando, Florida, United States, 32804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 severe 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 \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
  • * Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
  • * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • * Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
  • * Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
  • * Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
  • * Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
  • * Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2028-01-10