Clinical Trials in South Korea / NCT07216703
Recruiting
Phase 3
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)
NCT07216703 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Cervical Cancer
Investigational drug(s) / intervention(s)
Pembrolizumab →Sacituzumab Tirumotecan →Bevacizumab →Paclitaxel →Cisplatin →Carboplatin →Rescue Medications
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).
Study 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
Eligibility
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
Primary outcome measure(s)
- Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 69 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 66 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - 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) — Up to approximately 48 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. - Part 2 Maintenance Treatment: Overall Survival (OS) — Up to approximately 60 months
OS is defined as time from randomization to death due to any cause. OS will be presented.
Trial sites (180)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama- Birmingham ( Site 5015) | Birmingham | Alabama | Recruiting |
| Alaska Womens Cancer Care ( Site 5046) | Anchorage | Alaska | Recruiting |
| CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037) | Irvine | California | Recruiting |
| University of California Irvine Medical Center ( Site 6006) | Orange | California | Recruiting |
| Florida Cancer Specialists - South ( Site 7001) | Fort Myers | Florida | Recruiting |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 5043) | Miami Beach | Florida | Recruiting |
| Mount Sinai Comprehensive Cancer Center ( Site 6000) | Miami Beach | Florida | Recruiting |
| Florida Cancer Specialists - East ( Site 7000) | West Palm Beach | Florida | Recruiting |
| Winship Cancer Institute of Emory University ( Site 5005) | Atlanta | Georgia | Recruiting |
| Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005) | Savannah | Georgia | Recruiting |
| TRIALS 365 ( Site 6008) | Shreveport | Louisiana | Recruiting |
| Maryland Oncology Hematology (MOH) ( Site 8001) | Columbia | Maryland | Recruiting |
| Minnesota Oncology Hematology, PA ( Site 8003) | Edina | Minnesota | Recruiting |
| Women's Cancer Center of Nevada ( Site 6011) | Las Vegas | Nevada | Recruiting |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039) | Mineola | New York | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009) | New York | New York | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002) | Columbus | Ohio | Recruiting |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001) | Tulsa | Oklahoma | Recruiting |
| Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007) | Eugene | Oregon | Recruiting |
| Honickman Center ( Site 5033) | Philadelphia | Pennsylvania | Recruiting |
| Asplundh Cancer Pavilion ( Site 5002) | Willow Grove | Pennsylvania | Recruiting |
| Women & Infants Hospital ( Site 6003) | Providence | Rhode Island | Recruiting |
| University of Tennessee Medical Center ( Site 6012) | Knoxville | Tennessee | Recruiting |
| Texas Oncology - DFW ( Site 8005) | Fort Worth | Texas | Recruiting |
| Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010) | Houston | Texas | Recruiting |
| Texas Oncology-The Woodlands ( Site 8000) | The Woodlands | Texas | Recruiting |
| Texas Oncology - Northeast Texas ( Site 8002) | Tyler | Texas | Recruiting |
| University of Virginia Cancer Center ( Site 5044) | Charlottesville | Virginia | Recruiting |
| University of Virginia Cancer Center ( Site 6014) | Charlottesville | Virginia | Recruiting |
| Inova Schar Cancer Institute ( Site 5045) | Fairfax | Virginia | Recruiting |
| Centro de Oncología e Investigación de Buenos Aires ( Site 0107) | Berazategui | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105) | Mar del Plata | Buenos Aires | Recruiting |
| Fundación Respirar ( Site 0101) | Belgrano | Buenos Aires F.D. | Recruiting |
| Instituto Misionero del Cancer ( Site 0112) | Posadas | Misiones Province | Recruiting |
| Instituto de Oncologia de Rosario ( Site 0104) | Rosario | Santa Fe Province | Recruiting |
| Hospital Provincial del Centenario ( Site 0106) | Rosario | Santa Fe Province | Recruiting |
| Centro Medico Privado CEMAIC ( Site 0102) | Córdoba | Argentina | Recruiting |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111) | La Rioja | Argentina | Recruiting |
| Medizinische Universitaet Wien ( Site 0302) | Vienna | State of Vienna | Recruiting |
| Medizinische Universitat Graz ( Site 0303) | Graz | Styria | Recruiting |
+ 140 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in South Korea
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 NCT07216703 on ClinicalTrials.gov ↗ ← All trials in South Korea