Phase
Condition
Ovarian Cancer
Vaginal Cancer
Pelvic Cancer
Treatment
Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Giredestrant
Bevacizumab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Persistent or recurrent EOC that meets the following criteria: Histologicallyconfirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian,fallopian tube, or primary peritoneal cancer, including but not limited to low-gradeserous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma,undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cellcarcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable tocurative surgery
Measurable disease (at least one target lesion) according to RECIST v1.1
Previous treatment with one to four lines of therapy, at least one of which wasplatinum-based. Hormonal therapy does not count as a line of therapy.
Platinum-resistant disease, defined as disease progression during or within 6 monthsof last platinum therapy, with the following exception: Participants with primaryplatinum-refractory disease are excluded.
Submission of a representative tumor specimen that is suitable for next-generationsequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) todetermine treatment arm assignment and for central pathology review.
Submission of the local pathology report and, if available, any associated stainedslides that supported the local diagnosis of the histology (to be used for centralpathology review)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent or usecontraception, and agreement to refrain from donating eggs (if applicable)
In addition to the general inclusion criteria above, participants must meet all ofthe arm-specific inclusion criteria for the respective arm
Exclusion
General Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant or breastfeed during thestudy
Primary platinum-refractory disease, defined as progression during or within 4 weeksafter the last dose of the first-line platinum treatment
Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian,fallopian tube, or primary peritoneal cancer
Current diagnosis of solely borderline epithelial ovarian tumor
Current diagnosis of non-epithelial ovarian tumors
Current diagnosis of synchronous primary endometrial cancer
Prior history of primary endometrial cancer, with the following exception: a priordiagnosis of primary endometrial cancer is permitted if it meets all of thefollowing conditions: Stage IA, no lymphovascular invasion, International Federationof Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures
Symptomatic, untreated, or actively progressing CNS metastases
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy,gene therapy, vaccine therapy, or investigational therapy within 28 days prior toinitiation of study treatment
Treatment with hormonal therapy within 14 days prior to initiation of studytreatment
In addition to the general exclusion criteria above, participants can not meet anyof the arm-specific exclusion criteria for the respective arm
Study Design
Connect with a study center
Cabrini Hospital
Malvern, Victoria 3144
AustraliaSite Not Available
Cabrini Hospital; Cabrini Foundation
Malvern, Victoria 3144
AustraliaSite Not Available
St John of God Hospital; Bendat Cancer Centre
Subiaco, Western Australia 6008
AustraliaSite Not Available
UZ Leuven; Gyneacologische Oncologie
Leuven, 3000
BelgiumSite Not Available
CHU Sart-Tilman
Liège, 4000
BelgiumSite Not Available
Kingston General Hospital
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
McGill University Health Centre - Glen Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Fakultni nemocnice Brno Bohunice
Brno, 625 00
CzechiaSite Not Available
Gynekologicko-porodnicka klinika
Prague, 120 00
CzechiaSite Not Available
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex, 25030
FranceSite Not Available
Institut Bergonie; Oncologie
Bordeaux, 33076
FranceSite Not Available
Centre Francois Baclesse
Caen, 14076
FranceSite Not Available
Centre Francois Baclesse; Oncologie
Caen, 14076
FranceSite Not Available
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
Lyon, 69373
FranceSite Not Available
Centre Leon Berard
Lyon, 69373
FranceSite Not Available
Institut Régional du Cancer de Montpellier
Montpellier, 34298
FranceSite Not Available
Groupe Hospitalier Diaconesses
Paris, 75020
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35042
FranceSite Not Available
ICO - Site René Gauducheau
Saint Herblain, 44805
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31059
FranceSite Not Available
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif CEDEX, 94800
FranceSite Not Available
Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
Berlin, 13353
GermanySite Not Available
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden, 01307
GermanySite Not Available
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
Essen, 45136
GermanySite Not Available
Universitätsklinikum Mannheim
Mannheim, 68167
GermanySite Not Available
Universitätsklinikum Mannheim; Frauenklinik
Mannheim, 68167
GermanySite Not Available
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
Muenchen, 81377
GermanySite Not Available
Istituto Tumori Napoli
Napoli, Campania 80131
ItalySite Not Available
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
Napoli, Campania 80131
ItalySite Not Available
Policlinico Universitario Agostino Gemelli
Roma, Lazio 00168
ItalySite Not Available
IRCCS S. Raffaele
Milano, Lombardia 20132
ItalySite Not Available
IRCCS S. Raffaele; Ginecologia Oncologica
Milano, Lombardia 20132
ItalySite Not Available
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano, Lombardia 20141
ItalySite Not Available
I.R.C.C. Candiolo; Oncologia Medica e Ematologia
Candiolo, Piemonte 10060
ItalySite Not Available
A.O. U. Consorziale Policlinico di Bari
Bari, Puglia 70124
ItalySite Not Available
A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica
Bari, Puglia 70124
ItalySite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, (0)6351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
LLC Medscan
Moskva, Moskovskaja Oblast 119421
Russian FederationSite Not Available
FSBI "Federal Medical Research Center n.a. V.A.Almazov"
Sankt-peterburg, Sankt Petersburg 197341
Russian FederationSite Not Available
Chelyabisnk regional clinical center for oncology and nuclear medicine
Chelyabinsk, Sverdlovsk 454087
Russian FederationSite Not Available
FSBI "Federal Medical Research Center n.a. V.A.Almazov"
St. Petersburg, 197341
Russian FederationSite Not Available
Institutio Catalan De Oncologia
Badalona, Barcelona 08916
SpainSite Not Available
Institutio Catalan De Oncologia
Barcelona, 08908
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Victoria
Malaga, 29010
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, 29010
SpainSite Not Available
Hôpitaux Universitaires de Genève
Genève, 1205
SwitzerlandSite Not Available
Hôpitaux Universitaires de Genève; Département d'oncologie
Genève, 1205
SwitzerlandSite Not Available
Adana Baskent University Medical Faculty; Oncology
Adana, 01220
TurkeySite Not Available
Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
Ankara, 06490
TurkeySite Not Available
Koc University Medical Faculty; Department of Gynecology & Obstetrics
Istanbul, 34010
TurkeySite Not Available
Koc University Medical Faculty; Department of Gynecology & Obstetrics
Topkapi, 34010
TurkeySite Not Available
Western General Hospital
Edinburgh, EH4 2XU
United KingdomSite Not Available
Western General Hospital; Edinburgh Cancer Center
Edinburgh, EH4 2XU
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust - University College Hospital
London, NW1 2PG
United KingdomSite Not Available
Arizona Oncology - HOPE Wilmot
Tucson, Arizona 85710
United StatesSite Not Available
Kaiser Permanente - Irvine
Irvine, California 92618
United StatesSite Not Available
UCSF Helen Diller Family CCC
San Francisco, California 94158
United StatesSite Not Available
Northwestern University Medical School; Drug Information Center
Chicago, Illinois 60611
United StatesSite Not Available
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United StatesSite Not Available
Minnesota Oncology Hematology
Saint Paul, Minnesota 55102
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63108
United StatesSite Not Available
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
Saint Louis, Missouri 63108
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Oklahoma Health Sciences Center; Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
Springfield, Oregon 97477
United StatesSite Not Available
Northwest Cancer Specialists, P.C.
Tigard, Oregon 97223
United StatesSite Not Available
Pinnacle Health; Harrisburg Hospital Pharmacy
Harrisburg, Pennsylvania 17101
United StatesSite Not Available
Magee-Woman's Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390-8813
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Texas Oncology - Gulf Coast
The Woodlands, Texas 77380
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesSite Not Available
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesSite Not Available
University of Washington - Seattle Cancer Care Alliance; Medical Oncology
Seattle, Washington 98109
United StatesSite Not Available
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