Recruiting

Phase 3

Sac-TMT & PembrolizumabA Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06952504

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Carboplatin

Paclitaxel

Docetaxel

Sacituzumab Tirumotecan

Study Details

Brief summary:

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.

EC is a type of cancer that starts in the tissues inside the uterus (womb)
pMMR indicates that certain normal proteins are present in the cancer cells
Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
Recurrent means the cancer came back after surgery

Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

Conditions

Endometrial Cancer

Study ID

NCT06952504

Start date

May 22, 2025

Status verified date

Oct, 2026

Completion date

May 24, 2032

Anticipated

Primary completion date

May 24, 2032

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Key inclusion criteria include but are not limited to:

Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment

Key exclusion criteria include but are not limited to:

Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
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 uncontrolled, significant cardiovascular disease or cerebrovascular disease
Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

Study Design

Enrollment

1123 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).

During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

active comparator: Maintenance Treatment Arm B: Pembrolizumab Monotherapy

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).

During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

experimental: Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).

During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).

active comparator: Subsequent Treatment Arm B: Sacituzumab Tirumotecan Monotherapy

During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months).

During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.

Interventions

Pembrolizumab

Intravenous (IV) Infusion

Carboplatin

During the Induction Phase, participants receive carboplatin AUC 5 (mg/mL/min) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

Paclitaxel

During the Induction Phase, participants receive paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

Docetaxel

During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

Sacituzumab Tirumotecan

IV Infusion

Cisplatin

During the Induction Phase, participants may receive cisplatin (in place of carboplatin) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion

Primary outcome measure

Maintenance Treatment: Progression-Free Survival (PFS) [ Time Frame: Up to approximately 44 months ]
Maintenance Treatment: Overall Survival (OS) [ Time Frame: Up to approximately 54 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

University of South Alabama, Mitchell Cancer Institute ( Site 6033)

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Study Coordinator

251-665-8000

Alaska Women's Cancer Care ( Site 6036)

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Study Coordinator

907-562-4673

CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)

Recruiting

Irvine, California, United States, 92612

Contacts

Study Coordinator

714-456-8000

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)

Recruiting

Orange, California, United States, 92868

Contacts

Study Coordinator

949-813-1517

Sansum Clinic (Ridley Tree) ( Site 8007)

Recruiting

Solvang, California, United States, 93463

Contacts

Study Coordinator

805-879-0643

John Muir Health Cancer Center ( Site 6028)

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Study Coordinator

925-674-2580

Yale University School of Medicine ( Site 6009)

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-737-4450

MedStar Washington Hospital Center ( Site 5005)

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Study Coordinator

202-877-7000

Florida Cancer Specialists - South ( Site 7003)

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Study Coordinator

239-274-9930

UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Study Coordinator

352-273-7832

Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)

Recruiting

Orlando, Florida, United States, 32804

Contacts

Study Coordinator

407-609-3462

Florida Cancer Specialists ( Site 7002)

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Study Coordinator

727-522-0558

Florida Cancer Specialists East ( Site 7001)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

561-366-4100

St. Joseph's/Candler Health System ( Site 6021)

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Study Coordinator

912-819-5704

University of Chicago Medical Center ( Site 5002)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-1220

Parkview Research Center ( Site 6008)

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Study Coordinator

800-724-8326

Women's Cancer Care ( Site 6010)

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Study Coordinator

985-317-6005

TRIALS 365 ( Site 6005)

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Study Coordinator

318-408-1198

Maine Medical Center - Scarborough Campus ( Site 6042)

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Study Coordinator

207-396-7089

Tufts Medical Center ( Site 6052)

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Study Coordinator

617-636-2616

Minnesota Oncology Hematology, PA ( Site 8003)

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Study Coordinator

817-837-8660

St. Dominic's Hospital ( Site 5004)

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Study Coordinator

601-200-4970

The Center of Hope ( Site 5018)

Recruiting

Reno, Nevada, United States, 89511

Contacts

Study Coordinator

775-327-4673

Holy Name Medical Center ( Site 6011)

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Study Coordinator

201-227-6200

University of New Mexico Comprehensive Cancer Center ( Site 6046)

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Study Coordinator

505-272-4946

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

516-708-4821

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-731-6455

Memorial Sloan Kettering Cancer Center ( Site 6053)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

212-639-2000

Duke Cancer Institute ( Site 6049)

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Study Coordinator

919-684-3780

FirstHealth of the Carolinas ( Site 6037)

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Study Coordinator

910-715-8684

Miami Valley Hospital South ( Site 6014)

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Study Coordinator

937-438-7800

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

614-293-9337

Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Study Coordinator

937-395-6017

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Study Coordinator

918-505-3200

Oncology Associates of Oregon, P.C. ( Site 8005)

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Study Coordinator

541-736-3385

St. Luke's University Health Network ( Site 6041)

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Study Coordinator

484-503-4673

Hospital of the University of Pennsylvania ( Site 5007)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-662-2487

AHN West Penn Hospital ( Site 6006)

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Study Coordinator

412-578-1116

Women & Infants Hospital ( Site 5003)

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Study Coordinator

401-453-7520

Erlanger Medical Center ( Site 5009)

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Study Coordinator

423-778-3902

Texas Oncology - DFW ( Site 8004)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-413-1500

Houston Methodist Hospital ( Site 6057)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-441-6616

Texas Oncology-San Antonio Medical Center ( Site 8001)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-595-5300

Texas Oncology - Northeast Texas ( Site 8002)

Recruiting

Tyler, Texas, United States, 75702

Contacts

Study Coordinator

903-579-9800

Texas Oncology - Gulf Coast ( Site 8006)

Recruiting

Webster, Texas, United States, 77598

Contacts

Study Coordinator

281-332-7505

Inova Schar Cancer Institute ( Site 6003)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

Virginia Cancer Specialists (VCS) ( Site 8008)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-280-5390

VCU Health Adult Outpatient Pavillion ( Site 5000)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Study Coordinator

804-628-4368

BC Cancer Surrey ( Site 0621)

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Study Coordinator

604-930-2098

CancerCare Manitoba ( Site 0617)

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Study Coordinator

204-787-4156

NL Health Services ( Site 0602)

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Study Coordinator

709-777-6300

Royal Victoria Regional Health Centre ( Site 0615)

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Study Coordinator

705 728-9090x66228

London Health Sciences Centre ( Site 0611)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Study Coordinator

519-685-8500

Sault Area Hospital ( Site 0616)

Recruiting

Sault Ste. Marie, Ontario, Canada, P6B 0A8

Contacts

Study Coordinator

705-759-3434x4402

Sunnybrook Research Institute ( Site 0610)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

416 480-6100

Princess Margaret Cancer Center ( Site 0609)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-4501

Windsor Regional Cancer Program ( Site 0614)

Recruiting

Windsor, Ontario, Canada, N8W 1L9

Contacts

Study Coordinator

519-254-5577

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0607)

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Study Coordinator

514-252-3400 X5766

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Study Coordinator

514-890-8000 x30777

Jewish General Hospital ( Site 0606)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

McGill University Health Centre ( Site 0604)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

5145772241

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0608)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Study Coordinator

8193461110x12890

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Trophoblast cell surface antigen 2 (TROP2)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.