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NCT Number: NCT07216703

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)

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

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Parkinson Disease 4, Autosomal Dominant Lewy Body Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Oncología e Investigación de Buenos Aires ( Site 0107), Berazategui, Buenos Aires, Argentina

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About this study

This is a 2-part study.

In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab.

In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pembrolizumab

Biological

Intravenous (IV) Infusion

Other names: Keytruda®, MK-3475, SCH 900475

Sacituzumab tirumotecan

Biological

IV Infusion

Other names: sac-TMT, MK-2870, SKB264

Bevacizumab

Biological

IV Infusion

Other names: Avastin®, MVASI®

paclitaxel

Drug

IV Infusion

Other names: Taxol, Onxol

Cisplatin

Drug

IV Infusion

Other names: Platinol®

carboplatin

Drug

IV Infusion

Other names: Paraplatin®

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).

Primary outcomes

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • GOG Foundation

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Oct 14, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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