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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)

Primary Purpose

Cervical Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Paclitaxel

Cisplatin

Carboplatin

Bevacizumab

Placebo to pembrolizumab

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)
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

Sites / Locations

Alaska Women's Cancer Care ( Site 1770)
Arizona Oncology Associates, PC- HAL ( Site 8005)
UC Irvine Health ( Site 1796)
Smilow Cancer Hospital at Yale New Haven ( Site 1809)
H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)
Georgia Cancer Center at Augusta University ( Site 1767)
Barbara Ann Karmanos Cancer Institute ( Site 1785)
Henry Ford Health System ( Site 1810)
Washington University School of Medicine ( Site 1779)
Cancer Institute of New Jersey at University Hospital ( Site 1762)
Holy Name Medical Center ( Site 1776)
Mount Sinai Chelsea ( Site 1760)
Columbia University Medical Center ( Site 1800)
OSU Wexner Medical Center ( Site 1817)
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)
MUSC Hollings Cancer Center ( Site 1819)
West Cancer Center - East Campus ( Site 1763)
Texas Oncology-San Antonio Medical Center ( Site 8001)
Seattle Cancer Care Alliance ( Site 1777)
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)
Hospital Aleman ( Site 1005)
Hospital de Oncologia Angel Roffo ( Site 1003)
Instituto Medico Especializado Alexander Fleming ( Site 1009)
Centro Oncologico Riojano Integral ( Site 1004)
Centro Medico San Roque ( Site 1001)
Royal North Shore Hospital ( Site 1514)
Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)
Flinders Medical Centre ( Site 1513)
St John of God Subiaco Hospital ( Site 1512)
Monash Health-Monash Medical Centre ( Site 1519)
Tom Baker Cancer Centre ( Site 1728)
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
BC Cancer - Vancouver Center ( Site 1722)
CancerCare Manitoba ( Site 1725)
Queen Elizabeth II Health Sciences Centre ( Site 1731)
Juravinski Cancer Centre ( Site 1735)
London Regional Cancer Program - London HSC ( Site 1723)
The Ottawa Hospital Cancer Centre ( Site 1736)
Sunnybrook Research Institute ( Site 1733)
Princess Margaret Cancer Centre ( Site 1732)
CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
Oncocentro ( Site 1065)
Fundacion Arturo Lopez Perez FALP ( Site 1061)
Sociedad Oncovida S.A. ( Site 1069)
Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
Instituto Clinico Oncologico del Sur ( Site 1062)
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)
Instituto Nacional de Cancerologia E.S.E ( Site 1095)
Hemato Oncologos S.A. ( Site 1100)
Biomelab S A S ( Site 1104)
Oncomedica S.A. ( Site 1098)
Instituto Cancerologico de Narino Ltda ( Site 1097)
Centre Jean Perrin ( Site 1181)
Institut Paoli Calmettes ( Site 1182)
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)
Centre Eugene Marquis ( Site 1187)
Institut Curie - Centre Rene Huguenin ( Site 1185)
Universitaetsklinikum Carl Gustav Carus ( Site 1211)
Universitaetsklinikum Duesseldorf ( Site 1220)
Universitatsklinikum Essen AoR ( Site 1213)
Universitatsklinikum Hamburg-Eppendorf ( Site 1212)
Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)
Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)
Klinikum Oldenburg AoeR ( Site 1218)
Universitaet Regensburg ( Site 1221)
Soroka Medical Center ( Site 1363)
Rambam Medical Center ( Site 1364)
Shaare Zedek Medical Center ( Site 1366)
Hadassah Medical Center. Ein Kerem ( Site 1367)
Rabin Medical Center ( Site 1365)
Chaim Sheba Medical Center ( Site 1361)
Sourasky Medical Center ( Site 1362)
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)
Istituto Nazionale Tumori ( Site 1251)
Istituto Europeo di Oncologia ( Site 1250)
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)
Policlinico Universitario -Agostino Gemelli ( Site 1241)
The Jikei University Kashiwa Hospital ( Site 1701)
National Cancer Center Hospital East ( Site 1704)
Ehime University Hospital ( Site 1693)
Kurume University Hospital ( Site 1692)
National Hospital Organization Hokkaido Cancer Center ( Site 1700)
Hyogo Cancer Center ( Site 1705)
Iwate Medical University Hospital ( Site 1695)
University of the Ryukyus Hospital ( Site 1706)
Saitama Medical University International Medical Center ( Site 1691)
Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)
National Cancer Center Hospital ( Site 1702)
The Jikei University Hospital ( Site 1697)
The Cancer Institute Hospital of JFCR ( Site 1698)
Keio University Hospital ( Site 1699)
Keimyung University Dongsan Medical Center ( Site 1603)
Seoul National University Hospital ( Site 1602)
Asan Medical Center ( Site 1601)
Samsung Medical Center ( Site 1604)
Medical Care and Research S.A. de C.V. ( Site 1135)
Centro Estatal de Cancerologia de Chihuahua ( Site 1123)
Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)
Instituto Nacional de Cancerologia. ( Site 1130)
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)
Faicic S de RL de CV ( Site 1133)
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)
Centro Medico Monte Carmelo ( Site 1156)
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)
Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)
Hospital Nacional Arzobispo Loayza ( Site 1159)
Hospital Nacional Maria Auxiliadora ( Site 1155)
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)
Medical Rehabilitation Center ( Site 1337)
Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)
Municipal Clinical Oncology Center ( Site 1346)
National Research Ogarev Mordovia State University ( Site 1347)
National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)
Tomsk Scientific Research Institute of Oncology ( Site 1360)
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)
Hospital Quiron Madrid ( Site 1277)
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)
MD Anderson Cancer Center Madrid ( Site 1273)
Hospital Universitario Virgen Macarena ( Site 1274)
Kaohsiung Veterans General Hospital ( Site 1632)
China Medical University Hospital ( Site 1635)
Taichung Veterans General Hospital ( Site 1634)
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)
Taipei Veterans General Hospital ( Site 1631)
Chang Gung Medical Foundation. Linkou ( Site 1633)
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)
Hacettepe University Medical Faculty ( Site 1459)
Baskent Universitesi Ankara Hastanesi ( Site 1451)
Akdeniz Universitesi Tip Fakultesi ( Site 1453)
Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)
City Clinical Hosp.4 of DCC ( Site 1482)
MI Precarpathian Clinical Oncology Center ( Site 1487)
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)
National Cancer Institute of the MoH of Ukraine ( Site 1484)
MI Odessa Regional Oncological Centre ( Site 1493)
Medical Centre LLC Oncolife ( Site 1485)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab+Chemotherapy

Placebo+Chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

PFS Per RECIST 1.1 as Assessed by Investigator in All Participants

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

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Number of Participants Who Discontinued Study Treatment Due to an AE

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

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) Global Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. It incorporates 5 functional scales, 3 symptom scales, a global health status/QoL scale, & single items assessing additional symptoms commonly reported by cancer & perceived financial impact of the disease. All of the scales & single-item measures range in score from 0 to 100. Participant post-baseline EORTC QLQ-C30 scores were classified as "Improved", defined as a ≥10-point improvement in score from baseline & confirmed by the next visit; "Stable", defined as a ≥10-point increase or <10-point change in score from baseline confirmed in the next visit OR a <10-point change in score & a ≥10-point increase in score at the next visit; or "Deteriorated", defined as a ≥10-point deterioration in score from baseline when the criteria for improvement or stability were not met. Participants who did not achieve improvement/stability with confirmation or deterioration criteria were reported as "Other".

Full Information

NCT ID

NCT03635567

First Posted

August 15, 2018

Last Updated

September 20, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03635567

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

October 3, 2022 (Actual)

Study Completion Date

June 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

617 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab+Chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Placebo+Chemotherapy

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, KEYTRUDA®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

TAXOL®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

PLATINOL®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

PARAPLATIN®

Intervention Description

IV infusion

Intervention Type

Biological

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

AVASTIN®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Placebo to pembrolizumab

Other Intervention Name(s)

Normal Saline or Dextrose solution

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Description

Time Frame

Up to approximately 46 months

Title

PFS Per RECIST 1.1 as Assessed by Investigator in All Participants

Description

Time Frame

Up to approximately 46 months

Title

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

Description

Time Frame

Up to approximately 46 months

Title

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

Description

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.

Time Frame

Up to approximately 46 months

Title

OS in All Participants

Description

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

Time Frame

Up to approximately 46 months

Title

OS in Participants With PD-L1 CPS ≥10

Description

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.

Time Frame

Up to approximately 46 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 46 months

Title

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

Description

Time Frame

Up to approximately 46 months

Title

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

Description

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.

Time Frame

12 months

Title

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

Description

Time Frame

Up to approximately 46 months

Title

Number of Participants Who Experienced an Adverse Event (AE)

Description

Time Frame

Up to approximately 46 months

Title

Number of Participants Who Experienced a Serious AE (SAE)

Description

Time Frame

Up to approximately 46 months

Title

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

Description

Time Frame

Up to approximately 46 months

Title

Number of Participants Who Discontinued Study Treatment Due to an AE

Description

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

Time Frame

Up to approximately 43 months

Title

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Alaska Women's Cancer Care ( Site 1770)

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

Arizona Oncology Associates, PC- HAL ( Site 8005)

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

UC Irvine Health ( Site 1796)

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Smilow Cancer Hospital at Yale New Haven ( Site 1809)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

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

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Georgia Cancer Center at Augusta University ( Site 1767)

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Barbara Ann Karmanos Cancer Institute ( Site 1785)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Henry Ford Health System ( Site 1810)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University School of Medicine ( Site 1779)

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

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

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

Holy Name Medical Center ( Site 1776)

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Mount Sinai Chelsea ( Site 1760)

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

Columbia University Medical Center ( Site 1800)

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

OSU Wexner Medical Center ( Site 1817)

City

Hilliard

State/Province

Ohio

ZIP/Postal Code

43026

Country

United States

Facility Name

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

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

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

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

MUSC Hollings Cancer Center ( Site 1819)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

West Cancer Center - East Campus ( Site 1763)

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Texas Oncology-San Antonio Medical Center ( Site 8001)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Facility Name

Seattle Cancer Care Alliance ( Site 1777)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

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

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

B1884BBF

Country

Argentina

Facility Name

Hospital Aleman ( Site 1005)

City

Buenos Aires

ZIP/Postal Code

C1118AAT

Country

Argentina

Facility Name

Hospital de Oncologia Angel Roffo ( Site 1003)

City

Buenos Aires

ZIP/Postal Code

C1417DTB

Country

Argentina

Facility Name

Instituto Medico Especializado Alexander Fleming ( Site 1009)

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Centro Oncologico Riojano Integral ( Site 1004)

City

La Rioja

ZIP/Postal Code

F5300COE

Country

Argentina

Facility Name

Centro Medico San Roque ( Site 1001)

City

Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Royal North Shore Hospital ( Site 1514)

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Flinders Medical Centre ( Site 1513)

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

St John of God Subiaco Hospital ( Site 1512)

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Monash Health-Monash Medical Centre ( Site 1519)

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Tom Baker Cancer Centre ( Site 1728)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

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

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

BC Cancer - Vancouver Center ( Site 1722)

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

CancerCare Manitoba ( Site 1725)

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Queen Elizabeth II Health Sciences Centre ( Site 1731)

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Juravinski Cancer Centre ( Site 1735)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

London Regional Cancer Program - London HSC ( Site 1723)

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

The Ottawa Hospital Cancer Centre ( Site 1736)

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Sunnybrook Research Institute ( Site 1733)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Princess Margaret Cancer Centre ( Site 1732)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

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

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

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

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

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

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Oncocentro ( Site 1065)

City

Vina del Mar

State/Province

Valparaiso

ZIP/Postal Code

2520598

Country

Chile

Facility Name

Fundacion Arturo Lopez Perez FALP ( Site 1061)

City

Santiago

ZIP/Postal Code

7500921

Country

Chile

Facility Name

Sociedad Oncovida S.A. ( Site 1069)

City

Santiago

ZIP/Postal Code

7510032

Country

Chile

Facility Name

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

City

Santiago

ZIP/Postal Code

8330024

Country

Chile

Facility Name

Instituto Clinico Oncologico del Sur ( Site 1062)

City

Temuco

ZIP/Postal Code

4810469

Country

Chile

Facility Name

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

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

200001

Country

Colombia

Facility Name

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

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111511

Country

Colombia

Facility Name

Hemato Oncologos S.A. ( Site 1100)

City

Cali

State/Province

Valle

ZIP/Postal Code

760046

Country

Colombia

Facility Name

Biomelab S A S ( Site 1104)

City

Barranquilla

ZIP/Postal Code

080002

Country

Colombia

Facility Name

Oncomedica S.A. ( Site 1098)

City

Monteria

ZIP/Postal Code

230002

Country

Colombia

Facility Name

Instituto Cancerologico de Narino Ltda ( Site 1097)

City

Pasto

ZIP/Postal Code

520001

Country

Colombia

Facility Name

Centre Jean Perrin ( Site 1181)

City

Clermont Ferrand

ZIP/Postal Code

63011

Country

France

Facility Name

Institut Paoli Calmettes ( Site 1182)

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Centre Eugene Marquis ( Site 1187)

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Institut Curie - Centre Rene Huguenin ( Site 1185)

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Facility Name

Universitaetsklinikum Carl Gustav Carus ( Site 1211)

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinikum Duesseldorf ( Site 1220)

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Universitatsklinikum Essen AoR ( Site 1213)

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

City

Hannover

ZIP/Postal Code

30177

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

City

Muenchen

ZIP/Postal Code

80637

Country

Germany

Facility Name

Klinikum Oldenburg AoeR ( Site 1218)

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Universitaet Regensburg ( Site 1221)

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Soroka Medical Center ( Site 1363)

City

Beer-Sheva

ZIP/Postal Code

8410101

Country

Israel

Facility Name

Rambam Medical Center ( Site 1364)

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

Shaare Zedek Medical Center ( Site 1366)

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Hadassah Medical Center. Ein Kerem ( Site 1367)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Rabin Medical Center ( Site 1365)

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Chaim Sheba Medical Center ( Site 1361)

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Sourasky Medical Center ( Site 1362)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

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

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

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

City

Bolgna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Istituto Nazionale Tumori ( Site 1251)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Europeo di Oncologia ( Site 1250)

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Policlinico Universitario -Agostino Gemelli ( Site 1241)

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

The Jikei University Kashiwa Hospital ( Site 1701)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8567

Country

Japan

Facility Name

National Cancer Center Hospital East ( Site 1704)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Ehime University Hospital ( Site 1693)

City

Toon

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Kurume University Hospital ( Site 1692)

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

National Hospital Organization Hokkaido Cancer Center ( Site 1700)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Hyogo Cancer Center ( Site 1705)

City

Akashi

State/Province

Hyogo

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

Iwate Medical University Hospital ( Site 1695)

City

Shiwa-gun

State/Province

Iwate

ZIP/Postal Code

028-3695

Country

Japan

Facility Name

University of the Ryukyus Hospital ( Site 1706)

City

Nakagami-gun

State/Province

Okinawa

ZIP/Postal Code

903-0215

Country

Japan

Facility Name

Saitama Medical University International Medical Center ( Site 1691)

City

Hidaka

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

City

Sunto-gun

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

National Cancer Center Hospital ( Site 1702)

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

The Jikei University Hospital ( Site 1697)

City

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

The Cancer Institute Hospital of JFCR ( Site 1698)

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Keio University Hospital ( Site 1699)

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Keimyung University Dongsan Medical Center ( Site 1603)

City

Daegu

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

Seoul National University Hospital ( Site 1602)

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Asan Medical Center ( Site 1601)

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 1604)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

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

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

City

Ciudad de Mexico

ZIP/Postal Code

03100

Country

Mexico

Facility Name

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

City

Ciudad de Mexico

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Instituto Nacional de Cancerologia. ( Site 1130)

City

Mexico

ZIP/Postal Code

14080

Country

Mexico

Facility Name

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

City

San Pedro Garza Garcia

ZIP/Postal Code

66269

Country

Mexico

Facility Name

Faicic S de RL de CV ( Site 1133)

City

Veracruz

ZIP/Postal Code

91900

Country

Mexico

Facility Name

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

City

Trujillo

State/Province

La Libertad

ZIP/Postal Code

13006

Country

Peru

Facility Name

Centro Medico Monte Carmelo ( Site 1156)

City

Arequipa

ZIP/Postal Code

04001

Country

Peru

Facility Name

Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

City

Lima

ZIP/Postal Code

15033

Country

Peru

Facility Name

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

City

Lima

ZIP/Postal Code

15036

Country

Peru

Facility Name

Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

City

Lima

ZIP/Postal Code

15038

Country

Peru

Facility Name

Hospital Nacional Arzobispo Loayza ( Site 1159)

City

Lima

ZIP/Postal Code

15082

Country

Peru

Facility Name

Hospital Nacional Maria Auxiliadora ( Site 1155)

City

Lima

ZIP/Postal Code

15801

Country

Peru

Facility Name

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Medical Rehabilitation Center ( Site 1337)

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

City

Novosibirsk

ZIP/Postal Code

630108

Country

Russian Federation

Facility Name

Municipal Clinical Oncology Center ( Site 1346)

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

National Research Ogarev Mordovia State University ( Site 1347)

City

Saransk

ZIP/Postal Code

430005

Country

Russian Federation

Facility Name

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

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Tomsk Scientific Research Institute of Oncology ( Site 1360)

City

Tomsk

ZIP/Postal Code

634028

Country

Russian Federation

Facility Name

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

City

Ufa

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

City

Doniostia - San Sebastian

State/Province

Guipuzcoa

ZIP/Postal Code

20014

Country

Spain

Facility Name

Hospital Quiron Madrid ( Site 1277)

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

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

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

MD Anderson Cancer Center Madrid ( Site 1273)

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena ( Site 1274)

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Kaohsiung Veterans General Hospital ( Site 1632)

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

China Medical University Hospital ( Site 1635)

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Taichung Veterans General Hospital ( Site 1634)

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

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

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 1631)

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Chang Gung Medical Foundation. Linkou ( Site 1633)

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

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

City

Adana

ZIP/Postal Code

01250

Country

Turkey

Facility Name

Hacettepe University Medical Faculty ( Site 1459)

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Baskent Universitesi Ankara Hastanesi ( Site 1451)

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Akdeniz Universitesi Tip Fakultesi ( Site 1453)

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

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

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

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

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

City

Konya

ZIP/Postal Code

42080

Country

Turkey

Facility Name

City Clinical Hosp.4 of DCC ( Site 1482)

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

MI Precarpathian Clinical Oncology Center ( Site 1487)

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

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

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

MI Odessa Regional Oncological Centre ( Site 1493)

City

Odesa

ZIP/Postal Code

65055

Country

Ukraine

Facility Name

Medical Centre LLC Oncolife ( Site 1485)

City

Zaporizhzhya

ZIP/Postal Code

69104

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

34534429

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.

Results Reference

derived

Links:

URL

https://www.merckclinicaltrials.com

Description

Merck Clinical Trials Information

Learn more about this trial

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