ACTIVE_NOT_RECRUITING

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

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Conditions

Endometrial CancerAntibody-drug conjugate (ADC)Trophoblast cell-surface antigen 2 (TROP2)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-12-06
Study Completion:2028-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06132958

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
  2. * 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).
  3. * 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.
  1. * Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
  2. * 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
  3. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  4. * 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
  5. * Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
  6. * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  7. * Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
  8. * Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
  9. * Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
  10. * Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
  11. * Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

USA Mitchell Cancer Institute ( Site 4142)
Mobile, Alabama, 36604
United States
Alaska Womens Cancer Care ( Site 4122)
Anchorage, Alaska, 99508
United States
HonorHealth (HH) ( Site 8000)
Phoenix, Arizona, 85016
United States
Arizona Oncology Associates - HOPE ( Site 8002)
Tucson, Arizona, 85711
United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
Los Angeles, California, 90095
United States
California Pacific Medical Center - Van Ness Campus ( Site 4129)
San Francisco, California, 94109
United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
New Haven, Connecticut, 06511
United States
MedStar Washington Hospital Center ( Site 4108)
Washington D.C., District of Columbia, 20010
United States
Mount Sinai Cancer Center ( Site 4117)
Miami Beach, Florida, 33140
United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
Orlando, Florida, 32804
United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, 33401
United States
Northside Hospital ( Site 4112)
Atlanta, Georgia, 30342
United States
Augusta University ( Site 4116)
Augusta, Georgia, 30912
United States
Centricity Research Columbus Cancer Center ( Site 4154)
Columbus, Georgia, 31904
United States
NorthShore University HealthSystem - Evanston Hospital ( Site 4110)
Evanston, Illinois, 60201
United States
Parkview Research Center at Parkview Regional Medical Center ( Site 4132)
Fort Wayne, Indiana, 46845
United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)
Edgewood, Kentucky, 41017
United States
University Medical Center New Orleans ( Site 4133)
New Orleans, Louisiana, 70112
United States
TRIALS 365 ( Site 4105)
Shreveport, Louisiana, 71103
United States
University of Massachusetts Memorial Medical Center ( Site 4103)
Worcester, Massachusetts, 01605
United States
Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)
St Louis, Missouri, 63110
United States
The Center of Hope ( Site 4109)
Reno, Nevada, 89511
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)
Hackensack, New Jersey, 07601
United States
Atlantic Health System Morristown Medical Center ( Site 4135)
Morristown, New Jersey, 07960
United States
Holy Name Medical Center ( Site 4115)
Teaneck, New Jersey, 07666
United States
New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)
Brooklyn, New York, 11215
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)
Mineola, New York, 11501
United States
Laura and Isaac Perlmutter Cancer Center ( Site 4106)
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)
New York, New York, 10029
United States
Good Samaritan Hospital Medical Center ( Site 4139)
West Islip, New York, 11795
United States
Duke Cancer Institute ( Site 4120)
Durham, North Carolina, 27710
United States
Sanford Health Roger Maris Cancer Center ( Site 4158)
Fargo, North Dakota, 58102
United States
University of Cincinnati Medical Center ( Site 4136)
Cincinnati, Ohio, 45219
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 4125)
Columbus, Ohio, 43210
United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)
Philadelphia, Pennsylvania, 19107
United States
AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)
Pittsburgh, Pennsylvania, 15244
United States
Asplundh Cancer Pavilion ( Site 4107)
Willow Grove, Pennsylvania, 19090
United States
Women & Infants Hospital ( Site 4138)
Providence, Rhode Island, 02905
United States
Sanford Cancer Center-Gynecologic Oncology ( Site 4121)
Sioux Falls, South Dakota, 57104
United States
The West Clinic, PLLC dba West Cancer Center ( Site 4102)
Germantown, Tennessee, 38138
United States
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)
Houston, Texas, 77030
United States
Texas Oncology - San Antonio ( Site 8005)
San Antonio, Texas, 78240
United States
Texas Oncology - Gulf Coast ( Site 8006)
The Woodlands, Texas, 77380
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2028-01-10

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2028-01-10

Terms related to this study

Keywords Provided by Researchers

  • Endometrial cancer
  • Antibody-drug conjugate (ADC)
  • Trophoblast cell-surface antigen 2 (TROP2)

Additional Relevant MeSH Terms

  • Endometrial Cancer