AzTrials
AzTrials

Endometrial NeoplasmsPhase 3NCT05173987

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

A Phase 3 study testing pembrolizumab, carboplatin and paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 194 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
pembrolizumab, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
194 sitesin 27 countries
Study dates
3 Feb 2022to 27 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
  • Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
  • Has received no prior systemic therapy for EC except for the following:
  • May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred ≥6 months after the last dose of chemotherapy.
  • May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
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  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
  • Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
  • Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
  • Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
  • If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
  • If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

Who cannot join

  • Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
  • Has EC of any histology that is proficient mismatch repair (pMMR).
  • Is a candidate for curative-intent surgery or curative-intent radiotherapy.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
  • Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
  • Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
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  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Has a known intolerance to any study intervention and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection, requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has had an allogenic tissue/solid organ transplant.

Trial locations and contacts

194 sites in 27 countries.

194 sites in 27 countries

United States35 sites

  • Northside Hospital ( Site 0017)

    Atlanta, Georgia, 30342

  • Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)

    Austin, Texas, 78731

  • Sanford Medical Center ( Site 0054)

    Bismarck, North Dakota, 58501

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)

    Cincinnati, Ohio, 45219

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0027)

    Columbus, Ohio, 43210

  • Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)

    Dallas, Texas, 75246

  • Karmanos Cancer Institute ( Site 0029)

    Detroit, Michigan, 48201

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)

    Fargo, North Dakota, 58102

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)

    Hackensack, New Jersey, 07601

  • St. Vincent Hospital and Health Care Center, Inc ( Site 0006)

    Indianapolis, Indiana, 46260

  • St. Dominic's Hospital ( Site 0024)

    Jackson, Mississippi, 39216

  • Moores Cancer Center ( Site 0037)

    La Jolla, California, 92093-0698

  • Baptist Health Lexington ( Site 0042)

    Lexington, Kentucky, 40503

  • Mount Sinai Cancer Center ( Site 0018)

    Miami Beach, Florida, 33140

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)

    New Haven, Connecticut, 06511

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai ( Site 0052)

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center ( Site 0009)

    New York, New York, 10065

  • Southeastern Regional Medical Center ( Site 0046)

    Newnan, Georgia, 30265

  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)

    Philadelphia, Pennsylvania, 19107

  • HonorHealth-USOR HonorHealth ( Site 8000)

    Phoenix, Arizona, 85016

  • FirstHealth Clinical Trials ( Site 0050)

    Pinehurst, North Carolina, 28374

  • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)

    Pittsburgh, Pennsylvania, 15213

  • AHN West Penn Hospital ( Site 0011)

    Pittsburgh, Pennsylvania, 15224

  • Providence Portland Medical Center ( Site 0031)

    Portland, Oregon, 97213

  • VCU Health Adult Outpatient Pavillion ( Site 0022)

    Richmond, Virginia, 23219

  • Kaiser Permanente Riverside Medical Center ( Site 0045)

    Riverside, California, 92505

  • Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)

    Rockville, Maryland, 20850

  • Sarasota Memorial Heath Care System ( Site 0005)

    Sarasota, Florida, 34239

  • Sanford Cancer Center-Gynecologic Oncology ( Site 0002)

    Sioux Falls, South Dakota, 57104

  • Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)

    Tyler, Texas, 75702

  • Asplundh Cancer Pavilion ( Site 0014)

    Willow Grove, Pennsylvania, 19090

  • University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)

    Worcester, Massachusetts, 01605

  • Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)

    Zion, Illinois, 60099

Other trials in United States

China31 sites

  • Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 0740)

    Beijing, Beijing Municipality, 100026

  • Peking University First Hospital ( Site 0723)

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer hospital ( Site 0715)

    Beijing, Beijing Municipality, 100142

  • Binzhou Medical University Hospital-Oncology department ( Site 0735)

    Binzhou, Shandong, 256603

  • The First Hospital of Jilin University ( Site 0705)

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University-Gynecology ( Site 0708)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 0709)

    Changsha, Hunan, 410013

  • West China Second University Hospital Sichuan University ( Site 0701)

    Chengdu, Sichuan, 610066

  • Southwest Hospital of Third Military Medical University ( Site 0719)

    Chongqing, Chongqing Municipality, 400038

  • The Second Affiliated Hospital of Chongqing Medical University ( Site 0745)

    Chongqing, Chongqing Municipality, 400072

  • Fuling Central Hospital ( Site 0733)

    Fulingqu, Chongqing Municipality, 408000

  • Fujian Provincial Cancer Hospital ( Site 0720)

    Fuzhou, Fujian, 350014

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)

    Guangzhou, Guangdong, 510700

  • Hainan General Hospital ( Site 0703)

    Haikou, Hainan, 570311

  • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)

    Hangzhou, Zhejiang, 310000

  • Zhejiang Cancer Hospital-Oncology ( Site 0700)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 0711)

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)

    Hefei, Anhui, 230001

  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)

    Kunming, Yunnan, 650107

  • The First Affiliated Hospital of Nanchang University ( Site 0729)

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital-Oncology Department ( Site 0707)

    Nanjing, Jiangsu, 210003

  • Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)

    Nanning, Guangxi, 530021

  • Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)

    Shanghai, Shanghai Municipality, 200011

  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)

    Shanghai, Shanghai Municipality, 201204

  • Cancer Hospital of Shantou University Medical College ( Site 0732)

    Shantou, Guangdong, 515031

  • Tianjin Cancer Hospital (Tianjin Medical University Cancer institute & Hospital) ( Site 0706)

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital-Medical Oncology ( Site 0716)

    Wuhan, Hubei, 430022

  • Shaanxi Provincial Cancer Hospital ( Site 0714)

    Xi'an, Shaanxi, 710061

  • Affiliated Hospital of Guangdong Medical University ( Site 0731)

    Zhanjiang, Guangdong, 524004

  • Henan Cancer Hospital ( Site 0713)

    Zhengzhou, Henan, 450008

Other trials in China

Japan17 sites

  • National Cancer Center Hospital ( Site 1607)

    Chuo-ku, Tokyo, 104-0045

  • Niigata University Medical & Dental Hospital ( Site 1613)

    Chuo-ku, Niigata, Niigata, 951-8520

  • National Hospital Organization Kyushu Cancer Center ( Site 1608)

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center ( Site 1605)

    Hidaka-shi, Saitama, 350-1200

  • National Cancer Center Hospital East ( Site 1604)

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital of JFCR ( Site 1616)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 1612)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 1611)

    Matsuyama, Ehime, 791-0280

  • The Jikei University Hospital ( Site 1615)

    Minato-ku, Tokyo, 105-8471

  • Shizuoka Cancer Center ( Site 1609)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1617)

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center ( Site 1603)

    Otashi, Gunma, 373-8550

  • Hokkaido University Hospital ( Site 1601)

    Sapporo, Hokkaido, 060-8648

  • Keio University Hospital ( Site 1606)

    Shinjyuku-ku, Tokyo, 160-8582

  • Iwate Medical University Hospital ( Site 1602)

    Shiwa-gun Yahaba-cho, Iwate, 028-3695

  • Ehime University Hospital ( Site 1614)

    Tōon, Ehime, 791-0295

  • University of Tsukuba Hospital ( Site 1618)

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Italy10 sites

  • IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)

    Florence, Tuscany, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 1507)

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)

    Milan, 20141

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1501)

    Naples, Campania, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)

    Roma, 00168

  • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)

    Rome, Roma, 00144

  • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)

    Turin, Piedmont, 10128

  • AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)

    Vicenza, Veneto, 36100

Other trials in Italy

Canada9 sites

  • Cross Cancer Institute ( Site 0513)

    Edmonton, Alberta, T6G 1Z2

  • BC Cancer Kelowna ( Site 0517)

    Kelowna, British Columbia, V1Y 5L3

  • Centre Hospitalier de l'Université de Montréal ( Site 0519)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital ( Site 0504)

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre ( Site 0505)

    Montreal, Quebec, H4A 3J1

  • Saskatoon Cancer Center-Clinical Research Department ( Site 0520)

    Saskatoon, Saskatchewan, S7N 4H4

  • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0510)

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia8 sites

  • Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)

    Brno, Brno-mesto, 62500

  • Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)

    Nový Jiín, Novy Jicin, 741 01

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)

    Ostrava, Moravian-Silesian Region, 708 52

  • Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)

    Prague, Praha 2, 12808

  • Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)

    Prague, Praha 8, 180 00

  • Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)

    Prague, 10034

  • Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)

    Zlín, Zlín, 762 75

Other trials in Czechia

Netherlands8 sites

  • Amsterdam UMC, locatie AMC ( Site 1706)

    Amsterdam, North Holland, 1105 AZ

  • Catharina Ziekenhuis-Oncology ( Site 1704)

    Eindhoven, North Brabant, 5623 EJ

  • University Medical Center Groningen ( Site 1707)

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)

    Leiden, South Holland, 2333 ZA

  • Maastricht UMC+ ( Site 1709)

    Maastricht, Limburg, 6229 HX

  • Radboudumc-Medical Oncology ( Site 1703)

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum-Medical Oncology ( Site 1701)

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)

    Utrecht, 3584 CX

Other trials in Netherlands

Poland8 sites

  • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2002)

    Gliwice, Silesian Voivodeship, 44-102

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Centrum Onkologii Ziemi Lubelskiej ( Site 2006)

    Lublin, Lublin Voivodeship, 20-090

  • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2004)

    Poznan, Greater Poland Voivodeship, 61-848

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)

    Siedlce, Masovian Voivodeship, 08-110

  • Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)

    Warsaw, Masovian Voivodeship, 00-315

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2008)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Australia7 sites

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0205)

    Brisbane, Queensland, 4029

  • Monash Health ( Site 0202)

    Clayton, Victoria, 3168

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)

    Melbourne, Victoria, 3000

  • Epworth Freemasons ( Site 0203)

    Melbourne, Victoria, 3002

  • Northern Cancer Institute ( Site 0206)

    St Leonards, New South Wales, 2065

  • St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)

    Subiaco, Western Australia, 6008

  • Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

    Westmead, New South Wales, 2145

Other trials in Australia

Spain7 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)

    A Coruña, La Coruna, 15006

  • Hospital Universitari Vall d'Hebron ( Site 2403)

    Barcelona, 08035

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)

    Madrid, Madrid, Comunidad de, 28034

  • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)

    Pamplona, Navarre, 31009

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)

    Valencia, Valenciana, Comunitat, 46009

Other trials in Spain

Israel5 sites

  • Soroka Medical Center ( Site 1403)

    Beersheba, 8410101

  • Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)

    Haifa, 3109601

  • Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)

    Holon, 5822012

  • Shaare Zedek Medical Center ( Site 1404)

    Jerusalem, 9103102

  • Sheba Medical Center ( Site 1401)

    Ramat Gan, 5265601

Other trials in Israel

Taiwan5 sites

  • Taichung Veterans General Hospital ( Site 2602)

    Taichung, 407

  • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)

    Tainan, 704

  • National Taiwan University Hospital ( Site 2603)

    Taipei, 10002

  • Mackay Memorial Hospital ( Site 2601)

    Taipei, 10449

  • Taipei Veterans General Hospital ( Site 2605)

    Taipei, 112

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)

    Ankara, 06800

  • Akdeniz Universitesi Hastanesi ( Site 2701)

    Antalya, 07070

  • Istanbul Universitesi Cerrahpasa ( Site 2702)

    Fatih, Istanbul, 34098

  • Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)

    Istanbul, 34093

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • The Beatson West of Scotland Cancer Centre ( Site 2805)

    Glasgow, Glasgow City, G12 0YN

  • St Bartholomew's Hospital ( Site 2804)

    London, London, City of, EC1A 7BE

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)

    London, London, City of, SW3 6JJ

  • Hammersmith Hospital-Medical Oncology ( Site 2808)

    London, London, City of, W12 OHS

  • The Christie ( Site 2807)

    Manchester, England, M20 4BX

Other trials in United Kingdom

Denmark4 sites

  • Aalborg Universitetshospital, Syd ( Site 0905)

    Aalborg, North Denmark, 9000

  • Rigshospitalet ( Site 0903)

    Copenhagen, Capital Region, 2100

  • Herlev and Gentofte Hospital ( Site 0902)

    Copenhagen, Capital Region, 2730

  • Roskilde Sygehus-Oncology department ( Site 0904)

    Roskilde, Region Sjælland, DK-4000

Other trials in Denmark

Germany4 sites

  • Charité Campus Virchow-Klinikum ( Site 1103)

    Berlin, 13353

  • Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 1101)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Ulm. ( Site 1106)

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

South Korea4 sites

  • Seoul National University Hospital ( Site 2302)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2301)

    Seoul, 03722

  • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)

    Seoul, 05505

  • Gangnam Severance Hospital ( Site 2304)

    Seoul, 06273

Other trials in South Korea

Belgium3 sites

  • Institut Jules Bordet-Medicine Oncology ( Site 0321)

    Brussels, Bruxelles-Capitale, Region de, 1000

  • Grand Hôpital de Charleroi - Les Viviers ( Site 0323)

    Gilly, Hainaut, 6060

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)

    Liège, Liege, 4000

Other trials in Belgium

Brazil3 sites

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)

    Natal, Rio Grande do Norte, 59075-740

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)

    São Paulo, 01246-000

  • A. C. Camargo Cancer Center-CAPEC ( Site 3003)

    São Paulo, 01509-010

Other trials in Brazil

Chile3 sites

  • FALP-UIDO ( Site 0602)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 0604)

    Santiago, Region M. de Santiago, 832000

  • Bradfordhill-Clinical Area ( Site 0603)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

Finland3 sites

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)

    Helsinki, Uusimaa, 00290

  • Kuopion Yliopistollinen Sairaala ( Site 1002)

    Kuopio, Northern Savonia, 70200

  • Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)

    Tampere, Pirkanmaa, 33520

Other trials in Finland

Sweden3 sites

  • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)

    Lund, Skåne County, 22185

  • Karolinska Universitetssjukhuset Solna ( Site 2502)

    Stockholm, Stockholm County, 171 64

  • Norrlands universitetssjukhus-Cancercentrum ( Site 2503)

    Umeå, Västerbotten County, 901 85

Other trials in Sweden

Ireland2 sites

  • Bon Secours Cork Hospital ( Site 1305)

    Cork, T12 DV56

  • St. James's Hospital-Cancer clinical trials office ( Site 1301)

    Dublin, D08 E9P6

Other trials in Ireland

Russia2 sites

  • Moscow City Oncology Hospital #62 ( Site 2204)

    Krasnogorsk, Moscow Oblast, 143423

  • Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Hungary1 site

  • Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)

    Budapest, 1122

Other trials in Hungary

New Zealand1 site

  • Auckland City Hospital ( Site 1801)

    Auckland, 1023

Other trials in New Zealand

Norway1 site

  • Oslo universitetssykehus, Radiumhospitalet ( Site 1901)

    Oslo, 0379

Other trials in Norway

About this study

Official title: A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.

The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to 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) and Overall Survival (OS).

Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Endometrial Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    Intravenous (IV) infusion

  • carboplatinDrug

    Also called PARAPLATIN®

    IV infusion

  • paclitaxelDrug

    Also called TAXOL®

    IV infusion

  • docetaxelDrug

    Also called TAXOTERE®

    IV infusion

  • cisplatinDrug

    Also called PLATINOL-AQ®

    IV infusion

Study groups in NCT05173987
Study groupRoleWhat they receive
PembrolizumabExperimentalParticipants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years).
Receives: Biological: pembrolizumab
Carboplatin+paclitaxelActive comparatorParticipants receive a combination of paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: docetaxel; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be reported for participants.

    Measured: Up to approximately 45 months

  2. Overall Survival

    OS is defined as the time from randomization to death due to any cause. The OS will be reported for all participants.

    Measured: Up to approximately 59 months

Secondary outcomes (9)

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants who have a best response of confirmed 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 45 months

  2. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    DCR is defined, per RECIST 1.1, as the percentage of participants who have achieved 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) or demonstrated Stable Disease (SD) for at least 24 weeks. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.) The DCR as assessed by BICR will be presented.

    Measured: Up to approximately 45 months

  3. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    DOR is defined as the time from first documented evidence of CR or PR until the first documented date of disease progression (PD) or death due to any cause, whichever occurs first, for participants who demonstrate a confirmed 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 RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 45 months

  4. Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

    PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by investigator will be reported for participants.

    Measured: Up to approximately 45 months

  5. Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

    PFS2 is defined as the time from randomization to subsequent disease progression (PD) per RECIST 1.1 after initiation of a new anticancer therapy, or death due to any cause, whichever occurs first. Per RECIST 1.1, 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. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by investigator will be reported for participants.

    Measured: Up to approximately 45 months

  6. Number of Participants Who Experience at Least One Adverse Event (AE)

    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. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 27 months

  7. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    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. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 24 months

  8. Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

    Measured: Baseline and up to approximately 25 months

  9. Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.

    Measured: Baseline and up to approximately 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start3 Feb 2022
  3. Primary completion27 May 2027 (estimated)
  4. Study completion27 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173987
Sponsor's protocol ID
3475-C93
Other IDs
MK-3475-C93, KEYNOTE-C93, GOG-3064, ENGOT-en15, jRCT2011210065, 2023-506361-56-00, U1111-1292-6057, 2021-003185-12
Status last verified
Apr 2026
First submitted
20 Dec 2021
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Slomovitz BM, Zhu J, Yin R, Backes F, Bidzinski M, Gilbert L, Willmott LJ, Hasegawa K, Kim JW, Kroep JR, Romero I, Gultekin M, Wang PH, Baron-Hay S, Klat J, Rosengarten O, Polignano M, Berrios M, Cadoo K, Lassus H, Mackowiak-Matejczyk B, Lorusso D, Reyners AKL, Burton ER, Makker V, Yao L, Meng R, Orlowski R, Pignata S. First-line pembrolizumab versus carboplatin plus paclitaxel in participants with mismatch repair-deficient advanced or recurrent endometrial cancer (KEYNOTE-C93/GOG-3064/ENGOT-en15): interim analysis of a multicentre, open-label, randomised, active-comparator controlled, phase 3 trial. Lancet. 2026 Oct 26:S0140-6736(26)02095-7. doi: 10.1016/S0140-6736(26)02095-7. Online ahead of print.

    PubMed 42933458

  • McClain KM, Prabhu VS, Marupuru S, Meng K, Tran V, Orlowski R, Meng R, Green AK, Makker V. Real-world outcomes of first-line pembrolizumab monotherapy among dMMR/MSI-H advanced or recurrent endometrial cancer patients in the United States. Gynecol Oncol. 2026 Oct 9:S0090-8258(26)02101-3. doi: 10.1016/j.ygyno.2026.08.009. Online ahead of print.

    PubMed 42855328

  • Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.

    PubMed 40966692

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pembrolizumab, carboplatin and paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 194 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United States, China, Japan, Italy, Canada and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 45 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173987, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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