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Studies

Interventional Active not recruiting Phase 3

NCT04634877 on ClinicalTrials.gov

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

  • Sponsor: Merck Sharp & Dohme LLC
  • Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group
  • Enrollment: 990 (Estimated)
  • Study start: 2021-01-10 (Actual)
  • Primary completion: 2026-09-15 (Estimated)
  • Study completion: 2026-09-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

Conditions

  • Endometrial Neoplasms

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Carboplatin
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: Paclitaxel
  • Drug: Placebo for pembrolizumab
  • Drug: Docetaxel
  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: Cisplatin
  • Radiation: External Beam Radiotherapy (EBRT)
  • Radiation: External Beam Radiotherapy (EBRT)
  • Drug: Cisplatin (as radiosensitizer)
  • Drug: Cisplatin (as radiosensitizer)
  • Radiation: Brachytherapy
  • Radiation: Brachytherapy

Primary Outcome Measures

  • Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence (Up to approximately 42 months)
    DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.
  • Overall Survival (OS) (Up to approximately 54 months)
    OS is defined as the time from randomization to death due to any cause.

Countries

Argentina, Austria, Belgium, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Mexico, Norway, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

Locations and Investigators

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Gliwice, Poland
    • Rafał, Tarnawski
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie, Olsztyn, Poland
    • Monika, Kotyla
  • Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o., Siedlce, Poland
    • Lubomir, Bodnar
  • Szpital Kliniczny Im. Ks. Anny Mazowieckiej samodzielny publiczny zakład opieki zdrowotnej, Warsaw, Poland
    • Anna, Dańska-Bidzińska
  • Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku, Bialystok, Poland
    • Beata, Maćkowiak-Matejczyk
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach, Kielce, Poland
    • Marcin, Misiek
  • Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie, Poznan, Poland
    • Andrzej, Roszak
  • Karolinska University Hospital, Solna, Sweden
    • Hanna, Dahlstrand
  • Uppsala University Hospital, Uppsala, Sweden
    • Anthoula, Koliadi
  • Linkoping University Hospital Region Ostergotland, Linkoping, Sweden
    • Gabriel, Lindahl
  • Oslo University Hospital HF, Oslo, Norway
    • Kristina, Lindemann
  • University Hospital Of North Norway HF, Tromsoe, Norway
    • Anne Gry, Bentzen
  • Kuopio University Hospital, Kuopio, Finland
    • Marjo, Tuppurainen
  • Tampere University Hospital, Tampere, Finland
    • Annika, Auranen
  • Turku University Hospital, Turku, Finland
    • Sakari, Hietanen
  • Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy
    • Francesco, Raspagliesi
  • Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS, Candiolo, Italy
    • Vanesa, Gregorc
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, Italy
    • Germana, Tognon
  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Giorgia, Mangili
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy
    • Carmela, Pisano
  • I.F.O. Istituti Fisioterapici Ospitalieri, Rome, Italy
    • Antonella, Savarese
  • European Institute Of Oncology S.r.l., Milan, Italy
    • Nicoletta, Colombo
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    • Domenica, Lorusso
  • Istituto Oncologico Veneto, Padova, Italy
    • Valentina, Guarneri
  • Vseobecna Fakultni Nemocnice V Praze, Prague, Czechia
    • David, Cibula
  • Fakultni Nemocnice Brno, Brno-Stred, Czechia
    • Vít, Weinberger
  • Fakultni Nemocnice Kralovske Vinohrady, Prague 10, Czechia
  • University General Hospital Attikon, Athens, Greece
    • Amanda, Psyrri
  • Alexandra Hospital, Athens, Greece
    • Flora, Zagouri
  • Euromedica General Clinic Of Thessaloniki, Thessaloniki, Greece
    • George, Fountzilas
  • General University Hospital Of Patras, Patras, Greece
    • Αthina, Christopoulou
  • Medizinische Universitaet Innsbruck, Innsbruck, Austria
    • Christian, Marth
  • Medical University Of Graz, Graz, Austria
    • Edgar, Petru
  • Herlev Hospital, Herlev, Denmark
    • Nicoline, Raaschou-Jensen
  • Odense University Hospital, Odense C, Denmark
    • Trine, Jørgensen
  • Aalborg University Hospital, Aalborg, Denmark
    • Adam Andrzej, Luczak
  • Zealand University Hospital, Roskilde, Denmark
    • Dejan, Labudovic
  • Rigshospitalet, Copenhagen Oe, Denmark
    • Hanne From, Mathiesen
  • Universitair Ziekenhuis Gent, Gent, Belgium
    • Hannelore, Denys
  • UZ Leuven, Leuven, Belgium
    • Toon, Van Gorp
  • CHU Ambroise Pare, Mons, Belgium
    • Nathalie, Cornez
  • CHC MontLegia, Liege, Belgium
    • Maryam, Bourhaba
  • Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium
    • Greet, Huygh
  • Az Maria Middelares Gent, Gent, Belgium
  • CHU De Liege, Liege, Belgium
    • Christine, Gennigens
  • Centre Francois Baclesse, Caen Cedex 5, France
  • Institut Universitaire Du Cancer Toulouse-Oncopole, Toulouse Cedex 9, France
    • Laurence, Gladieff
  • Institut Bergonie, Bordeaux, France
  • Institut Gustave Roussy, Villejuif, France
    • Alexandra, Leary
  • Centre Antoine Lacassagne, Nice Cedex 2, France
    • Philippe, Follana

And 19 other sites.

Study Officials

  • Medical Director (Study Director) — Merck Sharp & Dohme LLC