> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-fff43628-4221-4fbe-966c-ce668769017b > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Participants 1,023 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Start date 2026-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) Number of sites 166 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Dates **Completion date** 2031-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **First posted** 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Primary completion date** 2031-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Start date** 2026-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Size and sites **Participants** 1,023 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Planned participants** 1,023 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Number of sites** 166 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Identifiers **Registry ID** NCT07216703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **ClinicalTrials.gov ID** NCT07216703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Outcomes ### Primary outcomes 1. Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs) Timeframe: 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. 2. Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE Timeframe: 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. 3. 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) Timeframe: 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. 4. Part 2 Maintenance Treatment: Overall Survival (OS) Timeframe: Up to approximately 60 months OS is defined as time from randomization to death due to any cause. OS will be presented. ### Secondary outcomes 1. Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator Timeframe: Up to approximately 60 months PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. PFS2 as assessed by the investigator will be presented. 2. Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs Timeframe: Up to approximately 64 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. 3. Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE Timeframe: Up to approximately 61 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. 4. 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 Timeframe: Baseline and up to approximately 58 months EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1 = Very poor to 7 = Excellent). The combined score of GHS and QoL is computed by averaging the raw scores of the 2 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100\. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 GHS and QoL combined score will be presented. 5. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score Timeframe: Baseline and up to approximately 58 months EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100\. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented. 6. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score Timeframe: Baseline and up to approximately 58 months EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100\. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented. 7. Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score Timeframe: Baseline and up to approximately 58 months EORTC QLQ-CX24 is a 24-item questionnaire that assesses symptoms common in women with cervical cancer and evaluates the impact of disease and/or its treatments. Items are rated on a 4-point scale (1 = Not at all to 4= Very Much) and are grouped into 3 multi-item scales (symptom experience, body image, and sexual/vaginal functioning) and 6 single-item scales (lymphedema, peripheral neuropathy, menopausal symptom, sexual concerns, sexual activity, and sexual enjoyment). The combined score is computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100\. Higher scores indicate more severe symptoms (lower quality of life) for symptoms scales, or better functioning for functional items. The change from baseline in the EORTC QLQ-CX24 combined score will be presented. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Sites - Florida Cancer Specialists - South ( Site 7001)Fort Myers, United StatesRecruiting - Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)Miami Beach, United StatesRecruiting - Mount Sinai Comprehensive Cancer Center ( Site 6000)Miami Beach, United StatesRecruiting - Florida Cancer Specialists - East ( Site 7000)West Palm Beach, United StatesRecruiting - Winship Cancer Institute of Emory University ( Site 5005)Atlanta, United StatesRecruiting - Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)Savannah, United StatesRecruiting - TRIALS 365 ( Site 6008)Shreveport, United StatesRecruiting - Maryland Oncology Hematology (MOH) ( Site 8001)Columbia, United StatesRecruiting - Minnesota Oncology Hematology, PA ( Site 8003)Edina, United StatesRecruiting - Women's Cancer Center of Nevada ( Site 6011)Las Vegas, United StatesRecruiting - Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)New York, United StatesRecruiting - Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)Tulsa, United StatesRecruiting - Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)Eugene, United StatesRecruiting - Asplundh Cancer Pavilion ( Site 5002)Willow Grove, United StatesRecruiting - Women & Infants Hospital ( Site 6003)Providence, United StatesRecruiting - University of Tennessee Medical Center ( Site 6012)Knoxville, United StatesRecruiting - Texas Oncology - DFW ( Site 8005)Fort Worth, United StatesRecruiting - Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)Houston, United StatesRecruiting - Texas Oncology-The Woodlands ( Site 8000)The Woodlands, United StatesRecruiting - Texas Oncology - Northeast Texas ( Site 8002)Tyler, United StatesRecruiting - University of Virginia Cancer Center ( Site 5044)Charlottesville, United StatesRecruiting - University of Virginia Cancer Center ( Site 6014)Charlottesville, United StatesRecruiting - Inova Schar Cancer Institute ( Site 5045)Fairfax, United StatesRecruiting - Centro de Oncología e Investigación de Buenos Aires ( Site 0107)Berazategui, ArgentinaRecruiting - Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)Mar del Plata, ArgentinaRecruiting And 141 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (7) - MK-2870-036 - 2025 - U1111-1319-9926 - 2025-521514-26-00 - GOG-3123 - jRCT2031250604 - ENGOT-cx22 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216703) ## Related records ### Drugs (6) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Sacituzumab tirumotecan](https://trialight.com/data/asset/sacituzumab-tirumotecan-25c916a3-8178-42d0-a6e5-c6d3a4149237.md) ### Collaborators (2) - European Network of Gynaecological Oncological Trial Groups (ENGOT) - GOG Foundation ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Primary condition ### Targets (17) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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