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 | Recruiting Phase 3 DMC FDA Drug

• 8 other identifiers: 2870-036U1111-1319-99262025-521514-26-00MK-2870-036TroFuse-036GOG-3123ENGOT-cx22jRCT2031250604
• Study Type: interventional
• Target: 1,023
• Locations: 17 countries
• Sites: 81

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

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)

Outcome Measures

Primary Outcomes (4)

• Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)

  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.

  Up to approximately 69 months

• Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE

  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.

  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)

  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.

  Up to approximately 48 months

• Part 2 Maintenance Treatment: Overall Survival (OS)

  OS is defined as time from randomization to death due to any cause. OS will be presented.

  Up to approximately 60 months

Secondary Outcomes (7)

• Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator

  Up to approximately 60 months

• Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs

  Up to approximately 64 months

• Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 61 months

• Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score

  Baseline and up to approximately 58 months

• Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score

  Baseline and up to approximately 58 months

Study Arms (3)

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

EXPERIMENTAL

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.

Biological: Pembrolizumab; Biological: Sacituzumab Tirumotecan; Biological: Bevacizumab; Drug: Rescue Medications

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

EXPERIMENTAL

During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin area under the curve \[AUC\]5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). 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.

Biological: Pembrolizumab; Biological: Sacituzumab Tirumotecan; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Rescue Medications

Part 2: Pembrolizumab +/- Bevacizumab

ACTIVE COMPARATOR

During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m\^2 q3w, and cisplatin 50 mg/m\^2 q3w (or carboplatin AUC5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). 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.

Biological: Pembrolizumab; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin

Interventions

Bevacizumab BIOLOGICAL

IV Infusion

Also known as: Avastin®, MVASI®

Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab; Part 2: Pembrolizumab +/- Bevacizumab; Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

Cisplatin DRUG

IV Infusion

Also known as: Platinol®

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

Rescue Medications DRUG

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).

Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab; Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

Sacituzumab Tirumotecan BIOLOGICAL

IV Infusion

Also known as: sac-TMT, MK-2870, SKB264

Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab; Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

Carboplatin DRUG

IV Infusion

Also known as: Paraplatin®

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

Pembrolizumab BIOLOGICAL

Intravenous (IV) Infusion

Also known as: Keytruda®, MK-3475, SCH 900475

Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab; Part 2: Pembrolizumab +/- Bevacizumab; Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

Paclitaxel DRUG

IV Infusion

Also known as: Taxol, Onxol

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GOG Foundation: collaborator
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (81)

Mount Sinai Comprehensive Cancer Center ( Site 6000)

Miami Beach, Florida, 33140, United States

RECRUITING

TRIALS 365 ( Site 6008)

Shreveport, Louisiana, 71103, United States

RECRUITING

Women's Cancer Center of Nevada ( Site 6011)

Las Vegas, Nevada, 89106, United States

RECRUITING

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

New York, New York, 10016, United States

RECRUITING

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

Eugene, Oregon, 97401, United States

RECRUITING

University of Tennessee Medical Center ( Site 6012)

Knoxville, Tennessee, 37920, United States

RECRUITING

Texas Oncology - DFW ( Site 8005)

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - Northeast Texas ( Site 8002)

Tyler, Texas, 75702, United States

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Fundación Respirar ( Site 0101)

Belgrano, Buenos Aires F.D., C1118AAT, Argentina

RECRUITING

Instituto de Oncologia de Rosario ( Site 0104)

Rosario, Santa Fe Province, S2000KZE, Argentina

RECRUITING

Hospital Provincial del Centenario ( Site 0106)

Rosario, Santa Fe Province, S2002KDS, Argentina

RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)

La Rioja, F5300COE, Argentina

RECRUITING

Antwerp University Hospital ( Site 0407)

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc ( Site 0402)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

RECRUITING

Grand Hopital de Charleroi ( Site 0404)

Charleroi, Hainaut, 6060, Belgium

RECRUITING

UZ Gent ( Site 0406)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Leuven ( Site 0401)

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Hospital São Lucas da PUCRS ( Site 0516)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)

São José do Rio Preto, São Paulo, 15091-000, Brazil

RECRUITING

IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)

São Paulo, São Paulo, 04014-002, Brazil

RECRUITING

Princess Margaret Cancer Centre ( Site 0601)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

McGill University Health Centre ( Site 0602)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

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

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

Clinica Somer ( Site 0903)

Rionegro, Antioquia, 054040, Colombia

RECRUITING

Centro Cancerológico del Caribe (CECAC) ( Site 0906)

Barranquilla, Atlántico, 080002, Colombia

RECRUITING

Instituto Nacional De Cancerologia ( Site 0909)

Bogotá, Bogota D.C., 110411, Colombia

RECRUITING

Oncomédica S.A.S ( Site 0905)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncólogos del Occidente S.A.S. ( Site 0908)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Nemocnice AGEL Novy Jicin a.s. ( Site 1004)

Nový Jičín, Moravskoslezský kraj, 741 01, Czechia

RECRUITING

Fakultni nemocnice Ostrava ( Site 1005)

Ostrava, Moravskoslezský kraj, 708 52, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady ( Site 1002)

Prague, Praha 10, 100 34, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)

Prague, 128 08, Czechia

RECRUITING

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)

Athens, Attica, 115 28, Greece

RECRUITING

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)

Chaïdári, Attica, 124 62, Greece

RECRUITING

Országos Onkológiai Intézet ( Site 1603)

Budapest, 1122, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont ( Site 1601)

Debrecen, 4032, Hungary

RECRUITING

Hillel Yaffe Medical Center ( Site 1903)

Hadera, 0038100, Israel

RECRUITING

Rambam Health Care Campus ( Site 1907)

Haifa, 3109601, Israel

RECRUITING

Carmel Hospital ( Site 1901)

Haifa, 3436212, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 1905)

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center ( Site 1904)

Petah Tikva, 4941492, Israel

RECRUITING

Sourasky Medical Center ( Site 1902)

Tel Aviv, 6423906, Israel

RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)

Meldola, Forli-Cesena, 47014, Italy

RECRUITING

Ospedale Humanitas San Pio X ( Site 2013)

Milan, Lombardy, 20159, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)

Milan, Milano, 20133, Italy

RECRUITING

Ospedale Cannizzaro ( Site 2010)

Catania, 95126, Italy

RECRUITING

Istituto Europeo di Oncologia ( Site 2003)

Milan, 20141, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)

Roma, 00168, Italy

RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)

Torino, 10128, Italy

RECRUITING

National Hospital Organization Hokkaido Cancer Center ( Site 2108)

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Hyogo Cancer Center ( Site 2118)

Akashi, Hyōgo, 673-8558, Japan

RECRUITING

Iwate Medical University Hospital ( Site 2116)

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

University of the Ryukyus Hospital ( Site 2117)

Ginowan, Okinawa, 901-2725, Japan

RECRUITING

Saitama Medical University International Medical Center ( Site 2106)

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 2119)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 2110)

Niigata, 951-8566, Japan

RECRUITING

Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)

Gliwice, Silesian Voivodeship, 44-102, Poland

RECRUITING

Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)

Siedlce, Warmian-Masurian Voivodeship, 08-110, Poland

RECRUITING

Swietokrzyskie Centrum Onkologii. ( Site 2602)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

National Cancer Center ( Site 2905)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Seoul National University Hospital ( Site 2901)

Jongno-gu, Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 2902)

Seodaemun-Gu, Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 2904)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 2903)

Seoul, 06351, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Girona ( Site 3002)

Girona, Gerona, 17007, Spain

RECRUITING

Hospital Universitari Vall d Hebron ( Site 3003)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Reina Sofia ( Site 3006)

Córdoba, 14004, Spain

RECRUITING

Hospital Ramon y Cajal ( Site 3005)

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 3007)

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz ( Site 3004)

Madrid, 28046, Spain

RECRUITING

Skanes Universitetssjukhus Lund ( Site 3103)

Lund, Skåne County, 22242, Sweden

RECRUITING

Karolinska Universitetssjukhuset-Solna ( Site 3102)

Stockholm, Stockholm County, 171 64, Sweden

RECRUITING

Linköping University Hospital ( Site 3101)

Linköping, Östergötland County, 581 85, Sweden

RECRUITING

National Taiwan University Hospital ( Site 3301)

Taiwan, Taipei, 10002, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 3304)

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 3308)

Tainan, 704, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 3303)

Taipei, 10449, Taiwan

RECRUITING

Chang Gung Memorial Hospital ( Site 3302)

Taoyuan District, 333, Taiwan

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Bevacizumab; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in Part 1 Safety Run-in are allocated to a single treatment arm. Participants in study Part 2 complete induction treatment and are then randomized to 1 of 2 maintenance treatment arms.

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): October 29, 2031
• Study Completion (Estimated): October 29, 2031
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GR (2); PL (3); CZ (4); JP (7); BR (4); KR (5); CO (5); US (8); IL (6); TW (5); IT (7); SE (3); ES (6); HU (2); BE (5); AR (5); CA (4)