AzTrials
AzTrials

Cervical CancerPhase 3NCT03635567

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

A Phase 3 study testing Pembrolizumab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 149 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Pembrolizumab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
617 participants
Where
149 sitesin 19 countries
Study dates
25 Oct 2018to 4 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are eligible.
  • Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
  • Has adequate organ function

Who cannot join

  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
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  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • 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 co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137)
  • Has received prior systemic chemotherapy for treatment of cervical cancer.
  • Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization
  • Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Has received a live vaccine within 30 days prior to randomization
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
  • Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab
  • Has had an allogeneic tissue/solid organ transplant

Trial locations and contacts

149 sites in 19 countries.

149 sites in 19 countries

United States20 sites

  • Alaska Women's Cancer Care ( Site 1770)

    Anchorage, Alaska, 99508

  • Georgia Cancer Center at Augusta University ( Site 1767)

    Augusta, Georgia, 30912

  • MUSC Hollings Cancer Center ( Site 1819)

    Charleston, South Carolina, 29425

  • Barbara Ann Karmanos Cancer Institute ( Site 1785)

    Detroit, Michigan, 48201

  • Henry Ford Health System ( Site 1810)

    Detroit, Michigan, 48202

  • West Cancer Center - East Campus ( Site 1763)

    Germantown, Tennessee, 38138

  • OSU Wexner Medical Center ( Site 1817)

    Hilliard, Ohio, 43026

  • Smilow Cancer Hospital at Yale New Haven ( Site 1809)

    New Haven, Connecticut, 06510

  • Mount Sinai Chelsea ( Site 1760)

    New York, New York, 10011

  • Columbia University Medical Center ( Site 1800)

    New York, New York, 10032

  • Cancer Institute of New Jersey at University Hospital ( Site 1762)

    Newark, New Jersey, 07103

  • University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health ( Site 1796)

    Orange, California, 92868

  • Arizona Oncology Associates, PC- HAL ( Site 8005)

    Phoenix, Arizona, 85016

  • Texas Oncology-San Antonio Medical Center ( Site 8001)

    San Antonio, Texas, 78240

  • Seattle Cancer Care Alliance ( Site 1777)

    Seattle, Washington, 98109

  • Washington University School of Medicine ( Site 1779)

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)

    Tampa, Florida, 33612

  • Holy Name Medical Center ( Site 1776)

    Teaneck, New Jersey, 07666

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)

    Tulsa, Oklahoma, 74146

Other trials in United States

Canada15 sites

  • Tom Baker Cancer Centre ( Site 1728)

    Calgary, Alberta, T2N 4N2

  • CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)

    Chicoutimi, Quebec, G7H 5H6

  • Queen Elizabeth II Health Sciences Centre ( Site 1731)

    Halifax, Nova Scotia, B3H 2Y9

  • Juravinski Cancer Centre ( Site 1735)

    Hamilton, Ontario, L8V 5C2

  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program - London HSC ( Site 1723)

    London, Ontario, N6A 5W9

  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)

    Montreal, Quebec, H2X 3E4

  • The Ottawa Hospital Cancer Centre ( Site 1736)

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)

    Québec, Quebec, G1R 2J6

  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Research Institute ( Site 1733)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 1732)

    Toronto, Ontario, M5G 2M9

  • BC Cancer - Vancouver Center ( Site 1722)

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba ( Site 1725)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Japan14 sites

  • Hyogo Cancer Center ( Site 1705)

    Akashi, Hyōgo, 673-8558

  • Saitama Medical University International Medical Center ( Site 1691)

    Hidaka, Saitama, 350-1298

  • The Jikei University Kashiwa Hospital ( Site 1701)

    Kashiwa, Chiba, 277-8567

  • National Cancer Center Hospital East ( Site 1704)

    Kashiwa, Chiba, 277-8577

  • Kurume University Hospital ( Site 1692)

    Kurume, Fukuoka, 830-0011

  • University of the Ryukyus Hospital ( Site 1706)

    Nakagami-gun, Okinawa, 903-0215

  • National Hospital Organization Hokkaido Cancer Center ( Site 1700)

    Sapporo, Hokkaido, 003-0804

  • Iwate Medical University Hospital ( Site 1695)

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

    Sunto-gun, Shizuoka, 411-8777

  • National Cancer Center Hospital ( Site 1702)

    Tokyo, 104-0045

  • The Jikei University Hospital ( Site 1697)

    Tokyo, 105-8471

  • The Cancer Institute Hospital of JFCR ( Site 1698)

    Tokyo, 135-8550

  • Keio University Hospital ( Site 1699)

    Tokyo, 160-8582

  • Ehime University Hospital ( Site 1693)

    Tōon, Ehime, 791-0295

Other trials in Japan

Germany9 sites

  • Universitaetsklinikum Carl Gustav Carus ( Site 1211)

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf ( Site 1220)

    Düsseldorf, 40225

  • Universitatsklinikum Essen AoR ( Site 1213)

    Essen, 45147

  • Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

    Hamburg, 20251

  • Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

    Hanover, 30177

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

    Kiel, 24105

  • Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

    München, 80637

  • Klinikum Oldenburg AoeR ( Site 1218)

    Oldenburg, 26133

  • Universitaet Regensburg ( Site 1221)

    Regensburg, 93053

Other trials in Germany

Russia9 sites

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

    Kazan', 420029

  • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)

    Moscow, 115478

  • Medical Rehabilitation Center ( Site 1337)

    Moscow, 125367

  • Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

    Novosibirsk, 630108

  • National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)

    Saint Petersburg, 197758

  • Municipal Clinical Oncology Center ( Site 1346)

    Saint Petersburg, 198255

  • National Research Ogarev Mordovia State University ( Site 1347)

    Saransk, 430005

  • Tomsk Scientific Research Institute of Oncology ( Site 1360)

    Tomsk, 634028

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)

    Ufa, 450054

Other trials in Russia

Israel7 sites

  • Soroka Medical Center ( Site 1363)

    Beersheba, 8410101

  • Rambam Medical Center ( Site 1364)

    Haifa, 3525408

  • Shaare Zedek Medical Center ( Site 1366)

    Jerusalem, 9103102

  • Hadassah Medical Center. Ein Kerem ( Site 1367)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 1365)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 1361)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 1362)

    Tel Aviv, 6423906

Other trials in Israel

Mexico7 sites

  • Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

    Chihuahua City, 31000

  • Medical Care and Research S.A. de C.V. ( Site 1135)

    Mérida, Yucatán, 97070

  • Instituto Nacional de Cancerologia. ( Site 1130)

    México, 14080

  • Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

    Mexico City, 03100

  • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)

    Mexico City, 06100

  • Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)

    San Pedro Garza García, 66269

  • Faicic S de RL de CV ( Site 1133)

    Veracruz, 91900

Other trials in Mexico

Peru7 sites

  • Centro Medico Monte Carmelo ( Site 1156)

    Arequipa, 04001

  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

    Lima, 15033

  • Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)

    Lima, 15036

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

    Lima, 15038

  • Hospital Nacional Arzobispo Loayza ( Site 1159)

    Lima, 15082

  • Hospital Nacional Maria Auxiliadora ( Site 1155)

    Lima, 15801

  • Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)

    Trujillo, La Libertad, 13006

Other trials in Peru

Turkey (Türkiye)7 sites

  • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)

    Adana, 01250

  • Hacettepe University Medical Faculty ( Site 1459)

    Ankara, 06230

  • Baskent Universitesi Ankara Hastanesi ( Site 1451)

    Ankara, 06490

  • Akdeniz Universitesi Tip Fakultesi ( Site 1453)

    Antalya, 07059

  • Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)

    Istanbul, 34722

  • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)

    Izmir, 35040

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

    Konya, 42080

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)

    Berazategui, Buenos Aires, B1884BBF

  • Hospital Aleman ( Site 1005)

    Buenos Aires, C1118AAT

  • Hospital de Oncologia Angel Roffo ( Site 1003)

    Buenos Aires, C1417DTB

  • Instituto Medico Especializado Alexander Fleming ( Site 1009)

    Buenos Aires, C1426ANZ

  • Centro Oncologico Riojano Integral ( Site 1004)

    La Rioja, F5300COE

  • Centro Medico San Roque ( Site 1001)

    San Miguel de Tucumán, T4000IAK

Other trials in Argentina

Colombia6 sites

  • Biomelab S A S ( Site 1104)

    Barranquilla, 080002

  • Instituto Nacional de Cancerologia E.S.E ( Site 1095)

    Bogota, Cundinamarca, 111511

  • Hemato Oncologos S.A. ( Site 1100)

    Cali, Valle del Cauca Department, 760046

  • Oncomedica S.A. ( Site 1098)

    Montería, 230002

  • Instituto Cancerologico de Narino Ltda ( Site 1097)

    Pasto, 520001

  • Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Italy6 sites

  • Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)

    Aviano, 33081

  • A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)

    Bolgna, 40138

  • Istituto Nazionale Tumori ( Site 1251)

    Milan, 20133

  • Istituto Europeo di Oncologia ( Site 1250)

    Milan, 20141

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

    Naples, 80131

  • Policlinico Universitario -Agostino Gemelli ( Site 1241)

    Roma, 00168

Other trials in Italy

Taiwan6 sites

  • Kaohsiung Veterans General Hospital ( Site 1632)

    Kaohsiung City, 813

  • China Medical University Hospital ( Site 1635)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 1634)

    Taichung, 40705

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)

    Taipei, 112

  • Taipei Veterans General Hospital ( Site 1631)

    Taipei, 112

  • Chang Gung Medical Foundation. Linkou ( Site 1633)

    Taoyuan, 33305

Other trials in Taiwan

Ukraine6 sites

  • City Clinical Hosp.4 of DCC ( Site 1482)

    Dnipropetrovsk, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 1487)

    Ivano-Frankivsk, 76018

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)

    Kharkiv, 61070

  • National Cancer Institute of the MoH of Ukraine ( Site 1484)

    Kyiv, 03022

  • MI Odessa Regional Oncological Centre ( Site 1493)

    Odesa, 65055

  • Medical Centre LLC Oncolife ( Site 1485)

    Zaporizhzhya, 69104

Other trials in Ukraine

Australia5 sites

  • Flinders Medical Centre ( Site 1513)

    Bedford Park, South Australia, 5042

  • Monash Health-Monash Medical Centre ( Site 1519)

    Clayton, 3168

  • Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital ( Site 1514)

    St Leonards, New South Wales, 2065

  • St John of God Subiaco Hospital ( Site 1512)

    Subiaco, Western Australia, 6008

Other trials in Australia

Chile5 sites

  • Fundacion Arturo Lopez Perez FALP ( Site 1061)

    Santiago, 7500921

  • Sociedad Oncovida S.A. ( Site 1069)

    Santiago, 7510032

  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

    Santiago, 8330024

  • Instituto Clinico Oncologico del Sur ( Site 1062)

    Temuco, 4810469

  • Oncocentro ( Site 1065)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

France5 sites

  • Centre Jean Perrin ( Site 1181)

    Clermont-Ferrand, 63011

  • Institut Paoli Calmettes ( Site 1182)

    Marseille, 13009

  • Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

    Paris, 75014

  • Centre Eugene Marquis ( Site 1187)

    Rennes, 35042

  • Institut Curie - Centre Rene Huguenin ( Site 1185)

    Saint-Cloud, 92210

Other trials in France

Spain5 sites

  • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)

    Badalona, 08916

  • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

    Doniostia - San Sebastian, Guipuzcoa, 20014

  • MD Anderson Cancer Center Madrid ( Site 1273)

    Madrid, 28033

  • Hospital Quiron Madrid ( Site 1277)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen Macarena ( Site 1274)

    Seville, 41009

Other trials in Spain

South Korea4 sites

  • Keimyung University Dongsan Medical Center ( Site 1603)

    Daegu, 42601

  • Seoul National University Hospital ( Site 1602)

    Seoul, 03080

  • Asan Medical Center ( Site 1601)

    Seoul, 05505

  • Samsung Medical Center ( Site 1604)

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).

Conditions
Cervical Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Uterine Cervical 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 MK-3475, KEYTRUDA®

    IV infusion

  • PaclitaxelDrug

    Also called TAXOL®

    IV infusion

  • CisplatinDrug

    Also called PLATINOL®

    IV infusion

  • CarboplatinDrug

    Also called PARAPLATIN®

    IV infusion

  • BevacizumabBiological

    Also called AVASTIN®

    IV infusion

  • Placebo to pembrolizumabDrug

    Also called Normal Saline or Dextrose solution

    IV infusion

Study groups in NCT03635567
Study groupRoleWhat they receive
Pembrolizumab+ChemotherapyExperimentalOn Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Biological: Bevacizumab
Placebo+ChemotherapyPlacebo comparatorOn Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Biological: Bevacizumab; Drug: Placebo to pembrolizumab

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 Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.

    Measured: Up to approximately 46 months

  2. PFS Per RECIST 1.1 as Assessed by Investigator in All Participants

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.

    Measured: Up to approximately 46 months

  3. PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.

    Measured: Up to approximately 46 months

  4. Overall Survival (OS) in Participants With PD-L1 CPS ≥1

    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.

    Measured: Up to approximately 46 months

  5. OS in All Participants

    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.

    Measured: Up to approximately 46 months

  6. OS in Participants With PD-L1 CPS ≥10

    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

    Measured: Up to approximately 46 months

Secondary outcomes (9)

  1. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator

    ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.

    Measured: Up to approximately 46 months

  2. Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator

    For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.

    Measured: Up to approximately 46 months

  3. Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.

    Measured: 12 months

  4. PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)

    PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.

    Measured: Up to approximately 46 months

  5. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was 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. The number of participants who experienced an AE is presented.

    Measured: Up to approximately 66 months

  6. Number of Participants Who Experienced a Serious AE (SAE)

    An SAE was defined as any untoward medical occurrence that, at any dose: a.) Resulted in death; b.) Was life-threatening; c.) Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant disability/incapacity; e.) Was a congenital anomaly/birth defect; f.) Other important medical events; h.) Was a new cancer (that is not a condition of the study) or i.) Was associated with an overdose. The number of participants who experienced an SAE is presented.

    Measured: Up to approximately 66 months

  7. Number of Participants Who Experienced an Immune-related AE (irAE)

    AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis;

    • Diarrhea/Colitis;
    • Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;
    • Type 1 diabetes mellitus or Hyperglycemia;
    • Hypophysitis;
    • Hyperthyroidism;
    • Hypothyroidism;
    • Nephritis and Renal dysfunction; and
    • Myocarditis. The number of participants who experienced an irAE is presented.

    Measured: Up to approximately 66 months

  8. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE was 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. The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to approximately 63 months

  9. Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score

    The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or <10-point change in score OR a <10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".

    Measured: Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months

Timeline

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

  1. First posted17 Aug 2018
  2. Study start25 Oct 2018
  3. Primary completion3 Oct 2022
  4. Study completion4 Jun 2024

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635567
Sponsor's protocol ID
3475-826
Other IDs
MK-3475-826, KEYNOTE-826, 184183, 2018-001440-53, 2018
Status last verified
Dec 2025
First submitted
15 Aug 2018
Last updated
4 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.

    PubMed 37910822

  • Hasegawa K, Colombo N, Tewari KS, Dubot C, Caceres MV, Lorusso D, Shapira-Frommer R, Salman P, Yanez E, Gumus M, de Mendoza MOH, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Jensen E, Toker S, Monk BJ. Pembrolizumab Plus Chemotherapy for Cervical Cancer: An Exploratory Analysis of the KEYNOTE-826 Randomized Clinical Trial. JAMA Oncol. 2026 Sep 10:e263547. doi: 10.1001/jamaoncol.2026.3547. Online ahead of print.

    PubMed 42720936

  • Kim YM, Nishio S, Kim SI, Hasegawa K, Dubot C, Caceres MV, Tewari KS, Lorusso D, Lee JW, Liou WS, Li K, Tekin C, Colombo N, Monk BJ. Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis. J Gynecol Oncol. 2025 Jul;36(4):e110. doi: 10.3802/jgo.2025.36.e110.

    PubMed 40590325

  • Monk BJ, van Mens S, Hale O, Boer J, van Hees F, Swami S, Muston D, Tekin C, Keefe S, Monberg M. Cost-Effectiveness of Pembrolizumab as First-Line Treatment in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer in the United States. Oncol Ther. 2025 Mar;13(1):85-98. doi: 10.1007/s40487-024-00311-5. Epub 2024 Nov 5.

    PubMed 39499492

  • Lorusso D, Colombo N, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera M, Samouelian V, Castonguay V, Arkhipov A, Li K, Toker S, Tekin C, Tewari KS, Monk BJ. Pembrolizumab plus chemotherapy for advanced and recurrent cervical cancer: final analysis according to bevacizumab use in the randomized KEYNOTE-826 study. Ann Oncol. 2025 Jan;36(1):65-75. doi: 10.1016/j.annonc.2024.10.002. Epub 2024 Oct 10.

    PubMed 39393777

  • Tewari KS, Colombo N, Monk BJ, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Toker S, Keefe SM, Lorusso D. Pembrolizumab or Placebo Plus Chemotherapy With or Without Bevacizumab for Persistent, Recurrent, or Metastatic Cervical Cancer: Subgroup Analyses From the KEYNOTE-826 Randomized Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):185-192. doi: 10.1001/jamaoncol.2023.5410.

    PubMed 38095881

  • Monk BJ, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Hurtado de Mendoza MO, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Martin Nguyen A, Monberg MJ, Colombo N, Lorusso D. Health-related quality of life with pembrolizumab or placebo plus chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer (KEYNOTE-826): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Apr;24(4):392-402. doi: 10.1016/S1470-2045(23)00052-9. Epub 2023 Mar 3.

    PubMed 36878237

  • Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

    PubMed 34534429

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by Merck Sharp & Dohme LLC at 149 sites in 19 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Canada, Japan, Germany, Russia and 14 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 (time frame: Up to approximately 46 months). The study lists 6 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 NCT03635567, which also lists 8 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 4 Feb 2026.

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