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Clinical Trials in Ireland / NCT06132958
Active, not recruiting Phase 3

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

NCT06132958 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2023-12-06
Last updated
2026-08-28

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanDoxorubicinPaclitaxelNab-paclitaxelRescue medications

Sacituzumab tirumotecan: 4 mg/kg of sacituzumab tirumotecan by IV infusion

Doxorubicin: 60 mg/m\^2 of doxorubicin by IV Infusion

Paclitaxel: 80 mg/m\^2 of paclitaxel by IV infusion

Nab-paclitaxel: 100 mg/m\^2 of nab-paclitaxel by IV infusion

Rescue medications: Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (242)

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

+ 202 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in Ireland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06132958 on ClinicalTrials.gov ↗ ← All trials in Ireland