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)

January 15, 2026 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 1005)
      • Buenos Aires, Argentina, C1417DTB
        • Hospital de Oncologia Angel Roffo ( Site 1003)
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming ( Site 1009)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral ( Site 1004)
      • San Miguel de Tucumán, Argentina, T4000IAK
        • Centro Medico San Roque ( Site 1001)
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1884BBF
        • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)
  • Australia
      • Clayton, Australia, 3168
        • Monash Health-Monash Medical Centre ( Site 1519)
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital ( Site 1514)
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre ( Site 1513)
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Subiaco Hospital ( Site 1512)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre ( Site 1728)
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver Center ( Site 1722)
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba ( Site 1725)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre ( Site 1731)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre ( Site 1735)
      • London, Ontario, Canada, N6A 5W9
        • London Regional Cancer Program - London HSC ( Site 1723)
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre ( Site 1736)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 1733)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 1732)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
  • Chile
      • Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez FALP ( Site 1061)
      • Santiago, Chile, 7510032
        • Sociedad Oncovida S.A. ( Site 1069)
      • Santiago, Chile, 8330024
        • Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
      • Temuco, Chile, 4810469
        • Instituto Clinico Oncologico del Sur ( Site 1062)
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Oncocentro ( Site 1065)
  • Colombia
      • Barranquilla, Colombia, 080002
        • Biomelab S A S ( Site 1104)
      • Montería, Colombia, 230002
        • Oncomedica S.A. ( Site 1098)
      • Pasto, Colombia, 520001
        • Instituto Cancerologico de Narino Ltda ( Site 1097)
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111511
        • Instituto Nacional de Cancerologia E.S.E ( Site 1095)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760046
        • Hemato Oncologos S.A. ( Site 1100)
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin ( Site 1181)
      • Marseille, France, 13009
        • Institut Paoli Calmettes ( Site 1182)
      • Paris, France, 75014
        • Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)
      • Rennes, France, 35042
        • Centre Eugene Marquis ( Site 1187)
      • Saint-Cloud, France, 92210
        • Institut Curie - Centre Rene Huguenin ( Site 1185)
  • Germany
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus ( Site 1211)
      • Düsseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf ( Site 1220)
      • Essen, Germany, 45147
        • Universitatsklinikum Essen AoR ( Site 1213)
      • Hamburg, Germany, 20251
        • Universitatsklinikum Hamburg-Eppendorf ( Site 1212)
      • Hanover, Germany, 30177
        • Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)
      • München, Germany, 80637
        • Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg AoeR ( Site 1218)
      • Regensburg, Germany, 93053
        • Universitaet Regensburg ( Site 1221)
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 1363)
      • Haifa, Israel, 3525408
        • Rambam Medical Center ( Site 1364)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center ( Site 1366)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center. Ein Kerem ( Site 1367)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1365)
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center ( Site 1361)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 1362)
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)
      • Bolgna, Italy, 40138
        • A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)
      • Milan, Italy, 20133
        • Istituto Nazionale Tumori ( Site 1251)
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia ( Site 1250)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)
      • Roma, Italy, 00168
        • Policlinico Universitario -Agostino Gemelli ( Site 1241)
  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 1702)
      • Tokyo, Japan, 105-8471
        • The Jikei University Hospital ( Site 1697)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 1698)
      • Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 1699)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8567
        • The Jikei University Kashiwa Hospital ( Site 1701)
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 1704)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 1693)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 1692)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center ( Site 1700)
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Hyogo Cancer Center ( Site 1705)
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital ( Site 1695)
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital ( Site 1706)
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center ( Site 1691)
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Centro Estatal de Cancerologia de Chihuahua ( Site 1123)
      • Mexico City, Mexico, 03100
        • Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
      • Mexico City, Mexico, 06100
        • CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)
      • México, Mexico, 14080
        • Instituto Nacional de Cancerologia. ( Site 1130)
      • San Pedro Garza García, Mexico, 66269
        • Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)
      • Veracruz, Mexico, 91900
        • Faicic S de RL de CV ( Site 1133)
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care and Research S.A. de C.V. ( Site 1135)
  • Peru
      • Arequipa, Peru, 04001
        • Centro Medico Monte Carmelo ( Site 1156)
      • Lima, Peru, 15033
        • Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)
      • Lima, Peru, 15036
        • Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)
      • Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza ( Site 1159)
      • Lima, Peru, 15801
        • Hospital Nacional Maria Auxiliadora ( Site 1155)
    • La Libertad
      • Trujillo, La Libertad, Peru, 13006
        • Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)
  • Russia
      • Kazan', Russia, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)
      • Moscow, Russia, 115478
        • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)
      • Moscow, Russia, 125367
        • Medical Rehabilitation Center ( Site 1337)
      • Novosibirsk, Russia, 630108
        • Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)
      • Saint Petersburg, Russia, 197758
        • National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)
      • Saint Petersburg, Russia, 198255
        • Municipal Clinical Oncology Center ( Site 1346)
      • Saransk, Russia, 430005
        • National Research Ogarev Mordovia State University ( Site 1347)
      • Tomsk, Russia, 634028
        • Tomsk Scientific Research Institute of Oncology ( Site 1360)
      • Ufa, Russia, 450054
        • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)
  • South Korea
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Medical Center ( Site 1603)
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 1602)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 1601)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 1604)
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid ( Site 1273)
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena ( Site 1274)
    • Guipuzcoa
      • Doniostia - San Sebastian, Guipuzcoa, Spain, 20014
        • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quiron Madrid ( Site 1277)
  • Taiwan
      • Kaohsiung City, Taiwan, 813
        • Kaohsiung Veterans General Hospital ( Site 1632)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 1635)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital ( Site 1634)
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 1631)
      • Taoyuan District, Taiwan, 33305
        • Chang Gung Medical Foundation. Linkou ( Site 1633)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe University Medical Faculty ( Site 1459)
      • Ankara, Turkey (Türkiye), 06490
        • Baskent Universitesi Ankara Hastanesi ( Site 1451)
      • Antalya, Turkey (Türkiye), 07059
        • Akdeniz Universitesi Tip Fakultesi ( Site 1453)
      • Istanbul, Turkey (Türkiye), 34722
        • Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)
      • Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 1482)
      • Ivano-Frankivsk, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 1487)
      • Kharkiv, Ukraine, 61070
        • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)
      • Kyiv, Ukraine, 03022
        • National Cancer Institute of the MoH of Ukraine ( Site 1484)
      • Odesa, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 1493)
      • Zaporizhzhya, Ukraine, 69104
        • Medical Centre LLC Oncolife ( Site 1485)
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care ( Site 1770)
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC- HAL ( Site 8005)
    • California
      • Orange, California, United States, 92868
        • UC Irvine Health ( Site 1796)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale New Haven ( Site 1809)
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University ( Site 1767)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute ( Site 1785)
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System ( Site 1810)
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine ( Site 1779)
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Cancer Institute of New Jersey at University Hospital ( Site 1762)
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center ( Site 1776)
    • New York
      • New York, New York, United States, 10011
        • Mount Sinai Chelsea ( Site 1760)
      • New York, New York, United States, 10032
        • Columbia University Medical Center ( Site 1800)
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • OSU Wexner Medical Center ( Site 1817)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Hollings Cancer Center ( Site 1819)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center - East Campus ( Site 1763)
    • Texas
      • San Antonio, Texas, United States, 78240
        • Texas Oncology-San Antonio Medical Center ( Site 8001)
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance ( Site 1777)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab+Chemotherapy
On 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: Cisplatin
IV infusion
Other Names:
  • PLATINOL®
Biological: Bevacizumab
IV infusion
Other Names:
  • AVASTIN®
Placebo Comparator: Placebo+Chemotherapy
On 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.
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: Cisplatin
IV infusion
Other Names:
  • PLATINOL®
Biological: Bevacizumab
IV infusion
Other Names:
  • AVASTIN®
Drug: Placebo to pembrolizumab
IV infusion
Other Names:
  • Normal Saline or Dextrose solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Up to approximately 46 months
PFS Per RECIST 1.1 as Assessed by Investigator in All Participants
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
Overall Survival (OS) in Participants With PD-L1 CPS ≥1
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
OS in All Participants
Time Frame: Up to approximately 46 months
OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
Up to approximately 46 months
OS in Participants With PD-L1 CPS ≥10
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator
Time Frame: 12 months
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.
12 months
PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 46 months
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.
Up to approximately 46 months
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
Time Frame: Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
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".
Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 66 months
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.
Up to approximately 66 months
Number of Participants Who Experienced a Serious AE (SAE)
Time Frame: Up to approximately 66 months
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.
Up to approximately 66 months
Number of Participants Who Experienced an Immune-related AE (irAE)
Time Frame: Up to approximately 66 months

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.
Up to approximately 66 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 63 months
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.
Up to approximately 63 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

October 3, 2022

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-826
  • MK-3475-826 (Other Identifier: MSD)
  • KEYNOTE-826 (Other Identifier: MSD)
  • 184183 (Registry Identifier: JAPAC-CTI)
  • 2018-001440-53 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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