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NCT06459180

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~686 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab TirumotecanPemetrexedTisotumab VedotinTopotecanVinorelbineGemcitabine

At a glance

Recruiting sites
0 of 240 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in
Measured over Up to approximately 46 months
+3 more outcomes measured

Conditions

Cervical Cancer

Explore related trials

Cervical Carcinoma

Where it's being run

240 sites across 155 states
Texas6
Italy6
Israel4
Lombardy4
Tokyo4
Japan4
South Korea4
California3

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has adequate organ function

Exclusion

Has Grade ≥2 peripheral neuropathy
Has 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.
Received prior systemic anticancer therapy
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
Known additional malignancy that is progressing or has required active treatment within the past 3 years
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Concurrent active Hepatitis B and active Hepatitis C virus infection
Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

What this trial measures

  • Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-inUp to approximately 46 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  • Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-inUp to approximately 46 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-inUp to approximately 46 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Overall Survival (OS) in Phase 3 PortionUp to approximately 35 months

    OS is defined as the time from randomization to death due to any cause.