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A 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)

RecruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,023 · Started: Jan 19, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07216703

Locations in the U.S.

AlabamaUniversity of Alabama- Birmingham ( Site 5015), Birmingham
CaliforniaCHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037), Irvine
University of California Irvine Medical Center ( Site 6006), Orange
FloridaFlorida Cancer Specialists - South ( Site 7001), Fort Myers
Mount Sinai Braman Comprehensive Cancer Center ( Site 5043), Miami Beach
Mount Sinai Comprehensive Cancer Center ( Site 6000), Miami Beach
Florida Cancer Specialists - East ( Site 7000), West Palm Beach
GeorgiaWinship Cancer Institute of Emory University ( Site 5005), Atlanta
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005), Savannah
LouisianaTRIALS 365 ( Site 6008), Shreveport
MarylandMaryland Oncology Hematology (MOH) ( Site 8001), Columbia
MinnesotaMinnesota Oncology Hematology, PA ( Site 8003), Edina
NevadaWomen's Cancer Center of Nevada ( Site 6011), Las Vegas
New YorkPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039), Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009), New York
OhioThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002), Columbus
OklahomaOklahoma Cancer Specialists and Research Institute, LLC ( Site 6001), Tulsa
OregonOncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007), Eugene
PennsylvaniaHonickman Center ( Site 5033), Philadelphia
Asplundh Cancer Pavilion ( Site 5002), Willow Grove
Rhode IslandWomen & Infants Hospital ( Site 6003), Providence
TennesseeUniversity of Tennessee Medical Center ( Site 6012), Knoxville
TexasTexas Oncology - DFW ( Site 8005), Fort Worth
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010), Houston
Texas Oncology-The Woodlands ( Site 8000), The Woodlands
Texas Oncology - Northeast Texas ( Site 8002), Tyler
VirginiaUniversity of Virginia Cancer Center ( Site 5044), Charlottesville
University of Virginia Cancer Center ( Site 6014), Charlottesville
Inova Schar Cancer Institute ( Site 5045), Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.