Recruiting

Phase 3

Sac-TMT, Pembrolizumab, BevacizumabA Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07216703

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Sacituzumab Tirumotecan

Bevacizumab

Paclitaxel

Cisplatin

Study Details

Brief summary:

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.

Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

The goals of this study are to learn:

About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and
If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

Conditions

Cervical Cancer

Study ID

NCT07216703

Start date

Jan 19, 2026

Status verified date

Sep, 2026

Completion date

Oct 29, 2031

Anticipated

Primary completion date

Oct 29, 2031

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

The main inclusion criteria include but are not limited to the following:

Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
Has an Eastern Cooperative Oncology Group performance status of 0 or 1
Has tumor programmed cell death ligand 1 expression of combined positive score ≥1

The main exclusion criteria include but are not limited to the following:

Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has received prior systemic anticancer therapy other than what is specified in this protocol
Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
Has a diagnosis of immunodeficiency
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system metastases and/or carcinomatous meningitis
Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

Study Design

Enrollment

1023 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab

Participants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 20 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

experimental: Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

During induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m\^2 q3w for up to 6 cycles, and cisplatin 50 mg/m\^2 q3w (or carboplatin area under the curve \[AUC\]5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long.

During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

active comparator: Part 2: Pembrolizumab +/- Bevacizumab

During induction treatment, participants will receive pembrolizumab 200 mg q3w for up to 8 cycles, paclitaxel 175 mg/m\^2 q3w for up to 6 cycles, and cisplatin 50 mg/m\^2 q3w (or carboplatin AUC 5 mg/mL/min q3w) for up to 6 cycles. Participants may also receive bevacizumab 15 mg/kg q3w for up to 8 cycles at the investigator's discretion. Each cycle will be 3 weeks long.

During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 20 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long.

Interventions

Pembrolizumab

Intravenous (IV) Infusion

Sacituzumab Tirumotecan

IV Infusion

Bevacizumab

IV Infusion

Paclitaxel

IV Infusion

Cisplatin

IV Infusion

Carboplatin

IV Infusion

Rescue Medications

Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Primary outcome measure

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 69 months ]
Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 66 months ]
Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 48 months ]
Part 2 Maintenance Treatment: Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Florida Cancer Specialists - South ( Site 7001)

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Study Coordinator

239-274-9930

Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

Mount Sinai Comprehensive Cancer Center ( Site 6000)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

Florida Cancer Specialists - East ( Site 7000)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

561-366-4100

Winship Cancer Institute of Emory University ( Site 5005)

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Study Coordinator

404-778-1900

Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Study Coordinator

912-819-5789

TRIALS 365 ( Site 6008)

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Study Coordinator

318-408-1198

Maryland Oncology Hematology (MOH) ( Site 8001)

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Study Coordinator

410-964-2212

Minnesota Oncology Hematology, PA ( Site 8003)

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Study Coordinator

952-928-2944

Women's Cancer Center of Nevada ( Site 6011)

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Study Coordinator

702-851-4672

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-404-4434

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

800-293-5066

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Study Coordinator

918-505-3200

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Study Coordinator

541-683-5001

Honickman Center ( Site 5033)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

215-955-6923

Asplundh Cancer Pavilion ( Site 5002)

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Study Coordinator

215-481-4000

Women & Infants Hospital ( Site 6003)

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Study Coordinator

401-430-4818

University of Tennessee Medical Center ( Site 6012)

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Study Coordinator

865-305-4893

Texas Oncology - DFW ( Site 8005)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-413-1500

Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-441-6616

Texas Oncology-The Woodlands ( Site 8000)

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Study Coordinator

281-296-0365

Texas Oncology - Northeast Texas ( Site 8002)

Recruiting

Tyler, Texas, United States, 75702

Contacts

Study Coordinator

903-579-9800

University of Virginia Cancer Center ( Site 5044)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-243-8109

University of Virginia Cancer Center ( Site 6014)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-243-8109

Inova Schar Cancer Institute ( Site 5045)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

Nova Scotia Cancer Centre ( Site 0617)

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Study Coordinator

902-473-6000

London Health Sciences Centre ( Site 0613)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Study Coordinator

519-685-8500

Sunnybrook Research Institute ( Site 0605)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

4164806100

Princess Margaret Cancer Centre ( Site 0601)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

4169464501

Centre Hospitalier de l'Université de Montréal ( Site 0616)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Study Coordinator

514-890-8000

McGill University Health Centre ( Site 0602)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-934-1934x31975

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Study Coordinator

4185254444x0

CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Study Coordinator

8193461110x12890

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 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 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.