Clinical trial NCT03635567: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 617
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
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
timeFrame: Up to approximately 46 months
measure: PFS Per RECIST 1.1 as Assessed by Investigator in All Participants
timeFrame: Up to approximately 46 months
measure: PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10
timeFrame: Up to approximately 46 months
measure: Overall Survival (OS) in Participants With PD-L1 CPS ≥1
timeFrame: Up to approximately 46 months
measure: OS in All Participants
timeFrame: Up to approximately 46 months
measure: OS in Participants With PD-L1 CPS ≥10
timeFrame: Up to approximately 46 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 46 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 46 months
measure: Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator
timeFrame: 12 months
measure: PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 46 months
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Experienced a Serious AE (SAE)
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Experienced an Immune-related AE (irAE)
timeFrame: Up to approximately 66 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 63 months
measure: 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
timeFrame: Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Women's Cancer Care ( Site 1770)
state: Alaska
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC- HAL ( Site 8005)
state: Arizona
city: Orange
country: United States
facility: UC Irvine Health ( Site 1796)
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven ( Site 1809)
state: Connecticut
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 1767)
state: Georgia
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute ( Site 1785)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 1810)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 1779)
state: Missouri
city: Newark
country: United States
facility: Cancer Institute of New Jersey at University Hospital ( Site 1762)
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center ( Site 1776)
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Chelsea ( Site 1760)
state: New York
city: New York
country: United States
facility: Columbia University Medical Center ( Site 1800)
state: New York
city: Hilliard
country: United States
facility: OSU Wexner Medical Center ( Site 1817)
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)
state: Oklahoma
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center ( Site 1819)
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center - East Campus ( Site 1763)
state: Tennessee
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Medical Center ( Site 8001)
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 1777)
state: Washington
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 1005)
city: Buenos Aires
country: Argentina
facility: Hospital de Oncologia Angel Roffo ( Site 1003)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming ( Site 1009)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 1004)
city: Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 1001)
city: St Leonards
country: Australia
facility: Royal North Shore Hospital ( Site 1514)
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre ( Site 1513)
state: South Australia
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital ( Site 1512)
state: Western Australia
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre ( Site 1519)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 1728)
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver Center ( Site 1722)
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 1725)
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre ( Site 1731)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre ( Site 1735)
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program - London HSC ( Site 1723)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre ( Site 1736)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 1733)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 1732)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 1065)
state: Valparaiso
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 1061)
city: Santiago
country: Chile
facility: Sociedad Oncovida S.A. ( Site 1069)
city: Santiago
country: Chile
facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur ( Site 1062)
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)
state: Cesar
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 1095)
state: Cundinamarca
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 1100)
state: Valle
city: Barranquilla
country: Colombia
facility: Biomelab S A S ( Site 1104)
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 1098)
city: Pasto
country: Colombia
facility: Instituto Cancerologico de Narino Ltda ( Site 1097)
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin ( Site 1181)
city: Marseille
country: France
facility: Institut Paoli Calmettes ( Site 1182)
city: Paris
country: France
facility: Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 1187)
city: Saint-Cloud
country: France
facility: Institut Curie - Centre Rene Huguenin ( Site 1185)
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 1211)
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf ( Site 1220)
city: Essen
country: Germany
facility: Universitatsklinikum Essen AoR ( Site 1213)
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf ( Site 1212)
city: Hannover
country: Germany
facility: Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)
city: Muenchen
country: Germany
facility: Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AoeR ( Site 1218)
city: Regensburg
country: Germany
facility: Universitaet Regensburg ( Site 1221)
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center ( Site 1363)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 1364)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1366)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 1367)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1365)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 1361)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1362)
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)
city: Bolgna
country: Italy
facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)
city: Milano
country: Italy
facility: Istituto Nazionale Tumori ( Site 1251)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1250)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)
city: Roma
country: Italy
facility: Policlinico Universitario -Agostino Gemelli ( Site 1241)
city: Kashiwa
country: Japan
facility: The Jikei University Kashiwa Hospital ( Site 1701)
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1704)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1693)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1692)
state: Fukuoka
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 1700)
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 1705)
state: Hyogo
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 1695)
state: Iwate
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital ( Site 1706)
state: Okinawa
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1691)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)
state: Shizuoka
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 1702)
city: Tokyo
country: Japan
facility: The Jikei University Hospital ( Site 1697)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 1698)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 1699)
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center ( Site 1603)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1602)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1601)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1604)
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V. ( Site 1135)
state: Yucatan
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua ( Site 1123)
city: Ciudad de Mexico
country: Mexico
facility: Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
city: Ciudad de Mexico
country: Mexico
facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia. ( Site 1130)
city: San Pedro Garza Garcia
country: Mexico
facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)
city: Veracruz
country: Mexico
facility: Faicic S de RL de CV ( Site 1133)
city: Trujillo
country: Peru
facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)
state: La Libertad
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo ( Site 1156)
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)
city: Lima
country: Peru
facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 1159)
city: Lima
country: Peru
facility: Hospital Nacional Maria Auxiliadora ( Site 1155)
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)
city: Moscow
country: Russian Federation
facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center ( Site 1337)
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)
city: Saint Petersburg
country: Russian Federation
facility: Municipal Clinical Oncology Center ( Site 1346)
city: Saransk
country: Russian Federation
facility: National Research Ogarev Mordovia State University ( Site 1347)
city: St. Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology ( Site 1360)
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)
city: Doniostia - San Sebastian
country: Spain
facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)
state: Guipuzcoa
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron Madrid ( Site 1277)
state: Madrid
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid ( Site 1273)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 1274)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 1632)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 1635)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1634)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1631)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 1633)
city: Adana
country: Turkey
facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty ( Site 1459)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 1451)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi ( Site 1453)
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)
city: Dnipropetrovsk
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 1482)
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 1487)
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 1484)
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 1493)
city: Zaporizhzhya
country: Ukraine
facility: Medical Centre LLC Oncolife ( Site 1485)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.