Phase
Condition
Cervical Cancer
Pelvic Cancer
Dysfunctional Uterine Bleeding
Treatment
Cisplatin
Paclitaxel
Pembrolizumab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamouscarcinoma, or adenocarcinoma of the cervix which has not been treated with systemicchemotherapy and is not amenable to curative treatment (such as with surgery and/orradiation). Prior chemotherapy utilized as a radiosensitizing agent and completed atleast 2 weeks prior to randomization with resolution of all treatment-relatedtoxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia areeligible.
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 useeffective contraception during the treatment period and for at least 120 days afterthe last dose of pembrolizumab/placebo and 210 days after the last dose ofchemotherapy/bevacizumab
Has measurable disease per RECIST 1.1 as assessed by the local siteinvestigator/radiology
Has provided archival tumor tissue sample or newly obtained core or excisionalbiopsy of a tumor lesion not previously irradiated for prospective determination ofProgrammed 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
Exclusion Criteria:
A WOCBP who has a positive urine pregnancy test within 72 hours prior torandomization
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Participants with known brain metastases may participate provided thatthe brain metastases have been previously treated (except with chemotherapy) and areradiographically stable.
Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years. Note: Participants with basal cell carcinoma ofthe skin, squamous cell carcinoma of the skin, transitional cell carcinoma ofurothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergonepotentially 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 ofimmunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease that has required systemic treatment in past 2years (i.e., with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency) is not considered a form of systemic treatment and is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis
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 orwith 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 surgeryprior to randomization
Has received prior radiotherapy within 2 weeks prior to randomization. Participantsmust have recovered from all radiation-related toxicities, not requirecorticosteroids, 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 itsexcipients.
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 investigationalagent or has used an investigational device within 4 weeks prior to randomization
Is pregnant or breastfeeding or expecting to conceive within the projected durationof the study, starting with the screening visit through 120 days following last doseof pembrolizumab/placebo and 210 days following last dose ofchemotherapy/bevacizumab
Has had an allogeneic tissue/solid organ transplant
Study Design
Connect with a study center
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)
Berazategui, Buenos Aires B1884BBF
ArgentinaSite Not Available
Hospital Aleman ( Site 1005)
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Hospital de Oncologia Angel Roffo ( Site 1003)
Buenos Aires, C1417DTB
ArgentinaSite Not Available
Instituto Medico Especializado Alexander Fleming ( Site 1009)
Buenos Aires, C1426ANZ
ArgentinaSite Not Available
Hospital de Oncologia Angel Roffo ( Site 1003)
Ciudad de Buenos Aires, C1417DTB
ArgentinaSite Not Available
Centro Oncologico Riojano Integral ( Site 1004)
La Rioja, F5300COE
ArgentinaSite Not Available
Centro Medico San Roque ( Site 1001)
Tucuman, T4000IAK
ArgentinaSite Not Available
Royal North Shore Hospital ( Site 1514)
St Leonards, New South Wales 2065
AustraliaSite Not Available
Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)
South Brisbane, Queensland 4101
AustraliaSite Not Available
Flinders Medical Centre ( Site 1513)
Bedford Park, South Australia 5042
AustraliaSite Not Available
St John of God Subiaco Hospital ( Site 1512)
Subiaco, Western Australia 6008
AustraliaSite Not Available
Monash Health-Monash Medical Centre ( Site 1519)
Clayton, 3168
AustraliaSite Not Available
Tom Baker Cancer Centre ( Site 1728)
Calgary, Alberta T2N 4N2
CanadaSite Not Available
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
Kelowna, British Columbia V1Y 5L3
CanadaSite Not Available
BC Cancer - Vancouver Center ( Site 1722)
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
CancerCare Manitoba ( Site 1725)
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
Queen Elizabeth II Health Sciences Centre ( Site 1731)
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Juravinski Cancer Centre ( Site 1735)
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
London Regional Cancer Program - London HSC ( Site 1723)
London, Ontario N6A 5W9
CanadaSite Not Available
The Ottawa Hospital Cancer Centre ( Site 1736)
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Centre ( Site 1732)
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Sunnybrook Research Institute ( Site 1733)
Toronto, Ontario M4N 3M5
CanadaSite Not Available
CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)
Chicoutimi, Quebec G7H 5H6
CanadaSite Not Available
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
Montreal, Quebec H2X 3E4
CanadaSite Not Available
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
Quebec, G1R 2J6
CanadaSite Not Available
Oncocentro ( Site 1065)
Vina del Mar, Valparaiso 2520598
ChileSite Not Available
Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
Santiago, 8330024
ChileSite Not Available
Fundacion Arturo Lopez Perez FALP ( Site 1061)
Santiago, 7500921
ChileSite Not Available
Sociedad Oncovida S.A. ( Site 1069)
Santiago, 7510032
ChileSite Not Available
Instituto Clinico Oncologico del Sur ( Site 1062)
Temuco, 4810469
ChileSite Not Available
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)
Valledupar, Cesar 200001
ColombiaSite Not Available
Instituto Nacional de Cancerologia E.S.E ( Site 1095)
Bogota, Cundinamarca 111511
ColombiaSite Not Available
Hemato Oncologos S.A. ( Site 1100)
Cali, Valle 760046
ColombiaSite Not Available
Biomelab S A S ( Site 1104)
Barranquilla, 080002
ColombiaSite Not Available
Oncomedica S.A. ( Site 1098)
Monteria, 230002
ColombiaSite Not Available
Instituto Cancerologico de Narino Ltda ( Site 1097)
Pasto, 520001
ColombiaSite Not Available
Centre Jean Perrin ( Site 1181)
Clermont Ferrand, 63011
FranceSite Not Available
Centre Jean Perrin ( Site 1181)
Clermont Ferrand Cedex 1, 63011
FranceSite Not Available
Institut Paoli Calmettes ( Site 1182)
Marseille, 13009
FranceSite Not Available
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)
Paris, 75014
FranceSite Not Available
Centre Eugene Marquis ( Site 1187)
Rennes, 35042
FranceSite Not Available
Institut Curie - Centre Rene Huguenin ( Site 1185)
Saint-Cloud, 92210
FranceSite Not Available
Universitaetsklinikum Carl Gustav Carus ( Site 1211)
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Duesseldorf ( Site 1220)
Duesseldorf, 40225
GermanySite Not Available
Universitatsklinikum Essen AoR ( Site 1213)
Essen, 45147
GermanySite Not Available
Universitatsklinikum Hamburg-Eppendorf ( Site 1212)
Hamburg, 20251
GermanySite Not Available
Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)
Hannover, 30177
GermanySite Not Available
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)
Kiel, 24105
GermanySite Not Available
Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)
Muenchen, 80637
GermanySite Not Available
Klinikum Oldenburg AoeR ( Site 1218)
Oldenburg, 26133
GermanySite Not Available
Universitaet Regensburg ( Site 1221)
Regensburg, 93053
GermanySite Not Available
Soroka Medical Center ( Site 1363)
Beer-Sheva, 8410101
IsraelSite Not Available
Rambam Medical Center ( Site 1364)
Haifa, 3525408
IsraelSite Not Available
Hadassah Medical Center. Ein Kerem ( Site 1367)
Jerusalem, 9112001
IsraelSite Not Available
Shaare Zedek Medical Center ( Site 1366)
Jerusalem, 9103102
IsraelSite Not Available
Rabin Medical Center ( Site 1365)
Petah Tikva, 4941492
IsraelSite Not Available
Chaim Sheba Medical Center ( Site 1361)
Ramat Gan, 5265601
IsraelSite Not Available
Sourasky Medical Center ( Site 1362)
Tel Aviv, 6423906
IsraelSite Not Available
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)
Aviano, 33081
ItalySite Not Available
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)
Bolgna, 40138
ItalySite Not Available
Istituto Europeo di Oncologia ( Site 1250)
Milano, 20141
ItalySite Not Available
Istituto Nazionale Tumori ( Site 1251)
Milano, 20133
ItalySite Not Available
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)
Napoli, 80131
ItalySite Not Available
Policlinico Universitario -Agostino Gemelli ( Site 1241)
Roma, 00168
ItalySite Not Available
National Cancer Center Hospital East ( Site 1704)
Kashiwa, Chiba 277-8577
JapanSite Not Available
The Jikei University Kashiwa Hospital ( Site 1701)
Kashiwa, Chiba 277-8567
JapanSite Not Available
Ehime University Hospital ( Site 1693)
Toon, Ehime 791-0295
JapanSite Not Available
Kurume University Hospital ( Site 1692)
Kurume, Fukuoka 830-0011
JapanSite Not Available
National Hospital Organization Hokkaido Cancer Center ( Site 1700)
Sapporo, Hokkaido 003-0804
JapanSite Not Available
Hyogo Cancer Center ( Site 1705)
Akashi, Hyogo 673-8558
JapanSite Not Available
Iwate Medical University Hospital ( Site 1695)
Morioka, Iwate 020-8505
JapanSite Not Available
Iwate Medical University Hospital ( Site 1695)
Shiwa-gun, Iwate 028-3695
JapanSite Not Available
University of the Ryukyus Hospital ( Site 1706)
Nakagami-gun, Okinawa 903-0215
JapanSite Not Available
Saitama Medical University International Medical Center ( Site 1691)
Hidaka, Saitama 350-1298
JapanSite Not Available
Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)
Sunto-gun, Shizuoka 411-8777
JapanSite Not Available
Keio University Hospital ( Site 1699)
Tokyo, 160-8582
JapanSite Not Available
National Cancer Center Hospital ( Site 1702)
Tokyo, 104-0045
JapanSite Not Available
The Cancer Institute Hospital of JFCR ( Site 1698)
Tokyo, 135-8550
JapanSite Not Available
The Jikei University Hospital ( Site 1697)
Tokyo, 105-8471
JapanSite Not Available
Keimyung University Dongsan Medical Center ( Site 1603)
Daegu, 42601
Korea, Republic ofSite Not Available
Asan Medical Center ( Site 1601)
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center ( Site 1604)
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital ( Site 1602)
Seoul, 03080
Korea, Republic ofSite Not Available
Medical Care and Research S.A. de C.V. ( Site 1135)
Merida, Yucatan 97070
MexicoSite Not Available
Centro Estatal de Cancerologia de Chihuahua ( Site 1123)
Chihuahua, 31000
MexicoSite Not Available
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)
Ciudad de Mexico, 06100
MexicoSite Not Available
Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
Ciudad de Mexico, 03100
MexicoSite Not Available
Instituto Nacional de Cancerologia. ( Site 1130)
Mexico, 14080
MexicoSite Not Available
Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
Mexico City, 03100
MexicoSite Not Available
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)
San Pedro Garza Garcia, 66269
MexicoSite Not Available
Faicic S de RL de CV ( Site 1133)
Veracruz, 91900
MexicoSite Not Available
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)
Trujillo, La Libertad 13006
PeruSite Not Available
Centro Medico Monte Carmelo ( Site 1156)
Arequipa, 04001
PeruSite Not Available
Hospital Nacional Arzobispo Loayza ( Site 1159)
Lima, 15082
PeruSite Not Available
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)
Lima, 15033
PeruSite Not Available
Hospital Nacional Maria Auxiliadora ( Site 1155)
Lima, 15801
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)
Lima, 15038
PeruSite Not Available
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)
Lima, 15036
PeruSite Not Available
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)
Kazan, 420029
Russian FederationSite Not Available
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)
Moscow, 115478
Russian FederationSite Not Available
Medical Rehabilitation Center ( Site 1337)
Moscow, 125367
Russian FederationSite Not Available
Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)
Novosibirsk, 630108
Russian FederationSite Not Available
Municipal Clinical Oncology Center ( Site 1346)
Saint Petersburg, 198255
Russian FederationSite Not Available
National Research Ogarev Mordovia State University ( Site 1347)
Saransk, 430005
Russian FederationSite Not Available
National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)
St. Petersburg, 197758
Russian FederationSite Not Available
Tomsk Scientific Research Institute of Oncology ( Site 1360)
Tomsk, 634028
Russian FederationSite Not Available
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)
Ufa, 450054
Russian FederationSite Not Available
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)
Doniostia - San Sebastian, Guipuzcoa 20014
SpainSite Not Available
Hospital Quiron Madrid ( Site 1277)
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)
Badalona, 08916
SpainSite Not Available
MD Anderson Cancer Center Madrid ( Site 1273)
Madrid, 28033
SpainSite Not Available
Hospital Universitario Virgen Macarena ( Site 1274)
Sevilla, 41009
SpainSite Not Available
Kaohsiung Veterans General Hospital ( Site 1632)
Kaohsiung, 813
TaiwanSite Not Available
China Medical University Hospital ( Site 1635)
Taichung, 40447
TaiwanSite Not Available
Taichung Veterans General Hospital ( Site 1634)
Taichung, 40705
TaiwanSite Not Available
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)
Taipei, 112
TaiwanSite Not Available
Taipei Veterans General Hospital ( Site 1631)
Taipei, 112
TaiwanSite Not Available
Chang Gung Medical Foundation. Linkou ( Site 1633)
Taoyuan, 33305
TaiwanSite Not Available
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)
Adana, 01250
TurkeySite Not Available
Baskent Universitesi Ankara Hastanesi ( Site 1451)
Ankara, 06490
TurkeySite Not Available
Hacettepe University Medical Faculty ( Site 1459)
Ankara, 06230
TurkeySite Not Available
Akdeniz Universitesi Tip Fakultesi ( Site 1453)
Antalya, 07059
TurkeySite Not Available
Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)
Istanbul, 34722
TurkeySite Not Available
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)
Izmir, 35040
TurkeySite Not Available
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)
Konya, 42080
TurkeySite Not Available
City Clinical Hosp.4 of DCC ( Site 1482)
Dnipropetrovsk, 49102
UkraineSite Not Available
MI Precarpathian Clinical Oncology Center ( Site 1487)
Ivano-Frankivsk, 76018
UkraineSite Not Available
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)
Kharkiv, 61070
UkraineSite Not Available
National Cancer Institute of the MoH of Ukraine ( Site 1484)
Kyiv, 03022
UkraineSite Not Available
MI Odessa Regional Oncological Centre ( Site 1493)
Odesa, 65055
UkraineSite Not Available
Medical Centre LLC Oncolife ( Site 1485)
Zaporizhzhya, 69104
UkraineSite Not Available
Alaska Women's Cancer Care ( Site 1770)
Anchorage, Alaska 99508
United StatesSite Not Available
Arizona Oncology Associates, PC- HAL ( Site 8005)
Phoenix, Arizona 85016
United StatesSite Not Available
UC Irvine Health ( Site 1796)
Orange, California 92868
United StatesSite Not Available
Smilow Cancer Hospital at Yale New Haven ( Site 1809)
New Haven, Connecticut 06510
United StatesSite Not Available
H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)
Tampa, Florida 33612
United StatesSite Not Available
Georgia Cancer Center at Augusta University ( Site 1767)
Augusta, Georgia 30912
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute ( Site 1785)
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Health System ( Site 1810)
Detroit, Michigan 48202
United StatesSite Not Available
Washington University School of Medicine ( Site 1779)
Saint Louis, Missouri 63110
United StatesSite Not Available
Cancer Institute of New Jersey at University Hospital ( Site 1762)
Newark, New Jersey 07103
United StatesSite Not Available
Holy Name Medical Center ( Site 1776)
Teaneck, New Jersey 07666
United StatesSite Not Available
Columbia University Medical Center ( Site 1800)
New York, New York 10032
United StatesSite Not Available
Mount Sinai Chelsea ( Site 1760)
New York, New York 10011
United StatesSite Not Available
OSU Wexner Medical Center ( Site 1817)
Hilliard, Ohio 43026
United StatesSite Not Available
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)
Tulsa, Oklahoma 74146
United StatesSite Not Available
MUSC Hollings Cancer Center ( Site 1819)
Charleston, South Carolina 29425
United StatesSite Not Available
West Cancer Center - East Campus ( Site 1763)
Germantown, Tennessee 38138
United StatesSite Not Available
Texas Oncology-San Antonio Medical Center ( Site 8001)
San Antonio, Texas 78240
United StatesSite Not Available
Seattle Cancer Care Alliance ( Site 1777)
Seattle, Washington 98109
United StatesSite Not Available
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