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
- Diseases
- Cervical cancer
- 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
Sites (83)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| AZORG Coordinator of this site? Confirm its status | Aalst | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Active, not recruiting |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Coordinator of this site? Confirm its status | Panagyurishte | Bulgaria | Active, not recruiting |
| Multi-profile Hospital for Active Treatment Heart and Brain EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| Complex Oncological Center - Plovdiv, EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Active, not recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Active, not recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Diakonie-Klinikum Schwaebisch Hall gGmbH Coordinator of this site? Confirm its status | Schwaebisch Hall | Germany | Active, not recruiting |
| Klinikum Worms gGmbH Coordinator of this site? Confirm its status | Worms | Germany | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Active, not recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont Ferrand Cedex1 | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| L'Hopital Prive Du Confluent Coordinator of this site? Confirm its status | Nantes Cedex 2 | France | Active, not recruiting |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hôpital Privé des Côtes d'Armor Coordinator of this site? Confirm its status | Plérin | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Areteio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Active, not recruiting |
| Mitera S.A. Coordinator of this site? Confirm its status | Marousi | Greece | Active, not recruiting |
| General Hospital Of Patras Agios Andreas Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Active, not recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Active, not recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Azienda Ospedaliera per l Emergenza Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Stichting Radboud Universitair Medisch Centrum Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.