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NCT06459180Active, not recruitingPhase 3

MK-2870 in Second-line Recurrent or Metastatic Cervical Cancer.

A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Sept 2026

Brief summary (registry, in English)

1. MK-2870 Run-in: To evaluate MK-2870 with respect to objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR) 2. MK-2870 Run-in: To evaluate the safety and tolerability of MK-2870 3. Phase 3 Portion: To compare MK-2870 to Treatment of Physician’s Choice (TPC) with respect to overall survival (OS)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
268 (estimated)
First submitted
14 May 2024
Start date
13 Sept 2024
Lead sponsor
Merck Sharp & Dohme LLC
EU CT number
2023-508323-12-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 268
  • 83 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent active Hepatitis B and active Hepatitis C virus infection.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
  • 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.

Other illness

  • Active infection requiring systemic therapy.
  • HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
  • Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician’s choice (TPC) and/or any of their excipients, or other biologic therapy.
  • Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
  • 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • 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.

Other

  • Has Grade ≥2 peripheral neuropathy.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Who the study is looking for

  • Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
  • Has adequate organ function.
  • Has recurrent or metastatic cervical cancer.
  • 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 MK-2870 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 (MK-2870 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (83)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Johannes Kepler University Linz
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LinzAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
AZORG
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AalstBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumActive, not recruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
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PanagyurishteBulgariaActive, not recruiting
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaActive, not recruiting
Complex Oncological Center - Plovdiv, EOOD
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PlovdivBulgariaActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
SLK-Kliniken Heilbronn GmbH
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HeilbronnGermanyActive, not recruiting
Universitaet Des Saarlandes
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HomburgGermanyActive, not recruiting
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Diakonie-Klinikum Schwaebisch Hall gGmbH
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Schwaebisch HallGermanyActive, not recruiting
Klinikum Worms gGmbH
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WormsGermanyActive, not recruiting
Region Midtjylland
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Institut Català d'Oncologia
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GironaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clinica Universidad de Navarra
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MadridSpainActive, not recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Besancon University Hospital Center
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Besancon CedexFranceActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceActive, not recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceActive, not recruiting
Hôpital Privé des Côtes d'Armor
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PlérinFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Areteio Hospital
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AthensGreeceActive, not recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceActive, not recruiting
Mitera S.A.
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MarousiGreeceActive, not recruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceActive, not recruiting
Cork University Hospital
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CorkIrelandActive, not recruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandActive, not recruiting
St James's Hospital
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Dublin 8IrelandActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyActive, not recruiting
Humanitas Mirasole S.p.A.
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MilanItalyActive, not recruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyActive, not recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Stichting Radboud Universitair Medisch Centrum
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Region Oestergoetland
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LinkopingSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.