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)

NCT ID: NCT03635567

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 617 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2024-06-04

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Paclitaxel

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Bevacizumab

Intervention Type: BIOLOGICAL

IV infusion

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.

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Bevacizumab

Intervention Type: BIOLOGICAL

IV infusion

Placebo to pembrolizumab

Intervention Type: DRUG

IV infusion

Interventions

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Paclitaxel

IV infusion

Intervention Type: DRUG

Cisplatin

IV infusion

Intervention Type: DRUG

Carboplatin

IV infusion

Intervention Type: DRUG

Bevacizumab

IV infusion

Intervention Type: BIOLOGICAL

Placebo to pembrolizumab

IV infusion

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; TAXOL®; PLATINOL®; PARAPLATIN®; AVASTIN®; Normal Saline or Dextrose solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Alaska Women's Cancer Care ( Site 1770)

Anchorage, Alaska, United States

Arizona Oncology Associates, PC- HAL ( Site 8005)

Phoenix, Arizona, United States

UC Irvine Health ( Site 1796)

Orange, California, United States

Smilow Cancer Hospital at Yale New Haven ( Site 1809)

New Haven, Connecticut, United States

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

Tampa, Florida, United States

Georgia Cancer Center at Augusta University ( Site 1767)

Augusta, Georgia, United States

Barbara Ann Karmanos Cancer Institute ( Site 1785)

Detroit, Michigan, United States

Henry Ford Health System ( Site 1810)

Detroit, Michigan, United States

Washington University School of Medicine ( Site 1779)

St Louis, Missouri, United States

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

Newark, New Jersey, United States

Holy Name Medical Center ( Site 1776)

Teaneck, New Jersey, United States

Mount Sinai Chelsea ( Site 1760)

New York, New York, United States

Columbia University Medical Center ( Site 1800)

New York, New York, United States

OSU Wexner Medical Center ( Site 1817)

Hilliard, Ohio, United States

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

Oklahoma City, Oklahoma, United States

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

Tulsa, Oklahoma, United States

MUSC Hollings Cancer Center ( Site 1819)

Charleston, South Carolina, United States

West Cancer Center - East Campus ( Site 1763)

Germantown, Tennessee, United States

Texas Oncology-San Antonio Medical Center ( Site 8001)

San Antonio, Texas, United States

Seattle Cancer Care Alliance ( Site 1777)

Seattle, Washington, United States

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

Berazategui, Buenos Aires, Argentina

Hospital Aleman ( Site 1005)

Buenos Aires, , Argentina

Hospital de Oncologia Angel Roffo ( Site 1003)

Buenos Aires, , Argentina

Instituto Medico Especializado Alexander Fleming ( Site 1009)

Buenos Aires, , Argentina

Centro Oncologico Riojano Integral ( Site 1004)

La Rioja, , Argentina

Centro Medico San Roque ( Site 1001)

San Miguel de Tucumán, , Argentina

Royal North Shore Hospital ( Site 1514)

St Leonards, New South Wales, Australia

Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

South Brisbane, Queensland, Australia

Flinders Medical Centre ( Site 1513)

Bedford Park, South Australia, Australia

St John of God Subiaco Hospital ( Site 1512)

Subiaco, Western Australia, Australia

Monash Health-Monash Medical Centre ( Site 1519)

Clayton, , Australia

Tom Baker Cancer Centre ( Site 1728)

Calgary, Alberta, Canada

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

Kelowna, British Columbia, Canada

BC Cancer - Vancouver Center ( Site 1722)

Vancouver, British Columbia, Canada

CancerCare Manitoba ( Site 1725)

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre ( Site 1731)

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre ( Site 1735)

Hamilton, Ontario, Canada

London Regional Cancer Program - London HSC ( Site 1723)

London, Ontario, Canada

The Ottawa Hospital Cancer Centre ( Site 1736)

Ottawa, Ontario, Canada

Sunnybrook Research Institute ( Site 1733)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 1732)

Toronto, Ontario, Canada

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

Chicoutimi, Quebec, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Oncocentro ( Site 1065)

Viña del Mar, Región de Valparaíso, Chile

Fundacion Arturo Lopez Perez FALP ( Site 1061)

Santiago, , Chile

Sociedad Oncovida S.A. ( Site 1069)

Santiago, , Chile

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

Santiago, , Chile

Instituto Clinico Oncologico del Sur ( Site 1062)

Temuco, , Chile

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

Valledupar, Cesar Department, Colombia

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

Bogota, Cundinamarca, Colombia

Hemato Oncologos S.A. ( Site 1100)

Cali, Valle del Cauca Department, Colombia

Biomelab S A S ( Site 1104)

Barranquilla, , Colombia

Oncomedica S.A. ( Site 1098)

Montería, , Colombia

Instituto Cancerologico de Narino Ltda ( Site 1097)

Pasto, , Colombia

Centre Jean Perrin ( Site 1181)

Clermont-Ferrand, , France

Institut Paoli Calmettes ( Site 1182)

Marseille, , France

Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

Paris, , France

Centre Eugene Marquis ( Site 1187)

Rennes, , France

Institut Curie - Centre Rene Huguenin ( Site 1185)

Saint-Cloud, , France

Universitaetsklinikum Carl Gustav Carus ( Site 1211)

Dresden, , Germany

Universitaetsklinikum Duesseldorf ( Site 1220)

Düsseldorf, , Germany

Universitatsklinikum Essen AoR ( Site 1213)

Essen, , Germany

Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

Hamburg, , Germany

Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

Hanover, , Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

Kiel, , Germany

Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

München, , Germany

Klinikum Oldenburg AoeR ( Site 1218)

Oldenburg, , Germany

Universitaet Regensburg ( Site 1221)

Regensburg, , Germany

Soroka Medical Center ( Site 1363)

Beersheba, , Israel

Rambam Medical Center ( Site 1364)

Haifa, , Israel

Shaare Zedek Medical Center ( Site 1366)

Jerusalem, , Israel

Hadassah Medical Center. Ein Kerem ( Site 1367)

Jerusalem, , Israel

Rabin Medical Center ( Site 1365)

Petah Tikva, , Israel

Chaim Sheba Medical Center ( Site 1361)

Ramat Gan, , Israel

Sourasky Medical Center ( Site 1362)

Tel Aviv, , Israel

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

Aviano, , Italy

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

Bolgna, , Italy

Istituto Nazionale Tumori ( Site 1251)

Milan, , Italy

Istituto Europeo di Oncologia ( Site 1250)

Milan, , Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

Napoli, , Italy

Policlinico Universitario -Agostino Gemelli ( Site 1241)

Roma, , Italy

The Jikei University Kashiwa Hospital ( Site 1701)

Kashiwa, Chiba, Japan

National Cancer Center Hospital East ( Site 1704)

Kashiwa, Chiba, Japan

Ehime University Hospital ( Site 1693)

Tōon, Ehime, Japan

Kurume University Hospital ( Site 1692)

Kurume, Fukuoka, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 1700)

Sapporo, Hokkaido, Japan

Hyogo Cancer Center ( Site 1705)

Akashi, Hyōgo, Japan

Iwate Medical University Hospital ( Site 1695)

Shiwa-gun, Iwate, Japan

University of the Ryukyus Hospital ( Site 1706)

Nakagami-gun, Okinawa, Japan

Saitama Medical University International Medical Center ( Site 1691)

Hidaka, Saitama, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital ( Site 1702)

Tokyo, , Japan

The Jikei University Hospital ( Site 1697)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 1698)

Tokyo, , Japan

Keio University Hospital ( Site 1699)

Tokyo, , Japan

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

Mérida, Yucatán, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

Chihuahua City, , Mexico

Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

Mexico City, , Mexico

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

Mexico City, , Mexico

Instituto Nacional de Cancerologia. ( Site 1130)

México, , Mexico

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

San Pedro Garza García, , Mexico

Faicic S de RL de CV ( Site 1133)

Veracruz, , Mexico

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

Trujillo, La Libertad, Peru

Centro Medico Monte Carmelo ( Site 1156)

Arequipa, , Peru

Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

Lima, , Peru

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

Lima, , Peru

Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

Lima, , Peru

Hospital Nacional Arzobispo Loayza ( Site 1159)

Lima, , Peru

Hospital Nacional Maria Auxiliadora ( Site 1155)

Lima, , Peru

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

Kazan', , Russia

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

Moscow, , Russia

Medical Rehabilitation Center ( Site 1337)

Moscow, , Russia

Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

Novosibirsk, , Russia

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

Saint Petersburg, , Russia

Municipal Clinical Oncology Center ( Site 1346)

Saint Petersburg, , Russia

National Research Ogarev Mordovia State University ( Site 1347)

Saransk, , Russia

Tomsk Scientific Research Institute of Oncology ( Site 1360)

Tomsk, , Russia

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

Ufa, , Russia

Keimyung University Dongsan Medical Center ( Site 1603)

Daegu, , South Korea

Seoul National University Hospital ( Site 1602)

Seoul, , South Korea

Asan Medical Center ( Site 1601)

Seoul, , South Korea

Samsung Medical Center ( Site 1604)

Seoul, , South Korea

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

Doniostia - San Sebastian, Guipuzcoa, Spain

Hospital Quiron Madrid ( Site 1277)

Pozuelo de Alarcón, Madrid, Spain

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

Badalona, , Spain

MD Anderson Cancer Center Madrid ( Site 1273)

Madrid, , Spain

Hospital Universitario Virgen Macarena ( Site 1274)

Seville, , Spain

Kaohsiung Veterans General Hospital ( Site 1632)

Kaohsiung City, , Taiwan

China Medical University Hospital ( Site 1635)

Taichung, , Taiwan

Taichung Veterans General Hospital ( Site 1634)

Taichung, , Taiwan

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

Taipei, , Taiwan

Taipei Veterans General Hospital ( Site 1631)

Taipei, , Taiwan

Chang Gung Medical Foundation. Linkou ( Site 1633)

Taoyuan District, , Taiwan

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

Adana, , Turkey (Türkiye)

Hacettepe University Medical Faculty ( Site 1459)

Ankara, , Turkey (Türkiye)

Baskent Universitesi Ankara Hastanesi ( Site 1451)

Ankara, , Turkey (Türkiye)

Akdeniz Universitesi Tip Fakultesi ( Site 1453)

Antalya, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

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

Izmir, , Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

Konya, , Turkey (Türkiye)

City Clinical Hosp.4 of DCC ( Site 1482)

Dnipropetrovsk, , Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1487)

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

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

Kyiv, , Ukraine

MI Odessa Regional Oncological Centre ( Site 1493)

Odesa, , Ukraine

Medical Centre LLC Oncolife ( Site 1485)

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Australia; Canada; Chile; Colombia; France; Germany; Israel; Italy; Japan; Mexico; Peru; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine

References

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.

Reference Type: RESULT

PMID: 37910822 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40590325 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39499492 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38095881 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36878237 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34534429 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-3475-826

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-826

Identifier Type: OTHER

Identifier Source: secondary_id

184183

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-001440-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-826

Identifier Type: -

Identifier Source: org_study_id