Phase
Condition
Ovarian Cysts
Vaginal Cancer
Ovarian Cancer
Treatment
INCB123667
Clinical Study ID
Ages 18-99 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, orprimary peritoneal cancer.
Have platinum-resistant disease:
Participants who have only had 1 line of platinum-based therapy must havereceived at least 4 cycles of a platinum-containing regimen.
Participants who have received 2 to 4 lines of platinum-based therapy must haveprogressed on or within 6 months after the last dose of platinum.
Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatmentbiopsy is preferred, however an archival sample is acceptable as long as the sampleis no older than 5 years.
Received at least 1 and no more than 4 prior lines of systemic therapy following theinitial diagnosis, after which single-agent therapy is considered an appropriatenext therapeutic option.
Must have received bevacizumab unless there was a contraindication for its use.
If the tumor tests positive for FRα, participants must have received mirvetuximabsoravtansine unless there is an exception for its use on medical grounds.
Exclusion
Exclusion Criteria:
Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumorscontaining any of these histologies, or low-grade/borderline ovarian cancer.
Have primary platinum-refractory disease: either did not respond (CR or PR) tofirst-line platinum-containing therapy or progressed on or within 3 months after thelast dose of the first line platinum-containing therapy.
The tumor tests positive for FRα but the participant has not received mirvetuximabsoravtansine for any reason other than medical contraindication.
Clinically significant or uncontrolled cardiac disease within 6 months before thefirst dose of study drug.
Known active CNS metastases and/or carcinomatous meningitis.
Known additional malignancy that is progressing or requires active treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
Connect with a study center
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown, New South Wales 02148
AustraliaSite Not Available
Concord General Repatriation Hospital
Concord, New South Wales 02139
AustraliaSite Not Available
Burnside War Memorial Hospital - the Brian Fricker Oncology Centre
Adelaide, South Australia 05065
AustraliaActive - Recruiting
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania 07000
AustraliaActive - Recruiting
Cancer Research Sa (Crsa)
Adelaide, 05000
AustraliaActive - Recruiting
Cancer Research Sa (Crsa)
Adelaide 2078025, 05000
AustraliaSite Not Available
Southern Oncology Clinical Research Unit
South Australia, 05042
AustraliaSite Not Available
Cliniques Universitaires St Luc Ucl
Brussels, B-1200
BelgiumActive - Recruiting
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels, 01070
BelgiumActive - Recruiting
Cliniques Universitaires St Luc Ucl
Brussels 2800866, B-1200
BelgiumSite Not Available
Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel
Brussels 2800866, 01070
BelgiumSite Not Available
Az Groeninge
Kortrijk, 08500
BelgiumActive - Recruiting
Universitair Ziekenhuis Leuven
Leuven, 03000
BelgiumActive - Recruiting
Chu Liege
Liège, 04000
BelgiumSite Not Available
Hyogo Cancer Center
Akashi-shi, 673-8558
JapanActive - Recruiting
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
JapanActive - Recruiting
Kurume University Hospital
Kurume, 830-0011
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
JapanActive - Recruiting
Shikoku Cancer Center
Matsuyama, 791-0280
JapanActive - Recruiting
Shikoku Cancer Center
Matsuyama 1926099, 791-0280
JapanSite Not Available
Hokkaido University Hospital
Sapporo, 060-8648
JapanActive - Recruiting
Shizuoka Cancer Center
Sunto-gun, 411-8777
JapanActive - Recruiting
Panoncology Trials
San Juan, PR 00935
Puerto RicoActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall D'Hebron
Barcelona, 08035
SpainActive - Recruiting
Instituto Catalan de Oncologia - Hospital Duran I Reynals
Barcelona, 08908
SpainSite Not Available
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona 3128760, 08036
SpainSite Not Available
Hospital Universitario Vall D'Hebron
Barcelona 3128760, 08035
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainSite Not Available
Institut Catala D'Oncologia Girona
Girona, 17007
SpainActive - Recruiting
Clinica Universidad de Navarra - Sede Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainSite Not Available
Hospital Universitario Virgen de La Arrixaca
Murcia, 30120
SpainActive - Recruiting
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia, 46010
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia 2509954, 46010
SpainSite Not Available
Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona
Bellinzona, 06500
SwitzerlandActive - Recruiting
Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona
Bellinzona 2661567, 06500
SwitzerlandSite Not Available
Kantonsspital Graubunden
Chur, 07000
SwitzerlandSite Not Available
Geneva University Hospitals-Hug
Geneva, 01211
SwitzerlandActive - Recruiting
Hopital Du Valais-Geneva University Hospitals - Hug
Geneva 2660646, 01211
SwitzerlandSite Not Available
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, 01011
SwitzerlandActive - Recruiting
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT
United KingdomActive - Recruiting
Hammersmith Hospital - Imperial College Healthcare Nhs Trust
London, W12 0HS
United KingdomActive - Recruiting
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
London, SM2 5PT
United KingdomActive - Recruiting
St Bartholomew'S Hospital
London, EC1A 7BE
United KingdomSite Not Available
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London 2643743, SE1 9RT
United KingdomSite Not Available
Hammersmith Hospital - Imperial College Healthcare Nhs Trust
London 2643743, W12 0HS
United KingdomActive - Recruiting
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
London 2643743, SM2 5PT
United KingdomSite Not Available
The Christie Nhs Foundation Trust
Manchester Greater, M204BX
United KingdomActive - Recruiting
Usa Health Mitchell Cancer Institute
Mobile, Alabama 36604
United StatesActive - Recruiting
University of California, Los Angeles Medical Center
Los Angeles, California 90024-6995
United StatesActive - Recruiting
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California 92103
United StatesActive - Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia 20010
United StatesActive - Recruiting
Florida Cancer Specialists & Research Institute
Fort Myers, Florida 33901
United StatesActive - Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida 33401
United StatesActive - Recruiting
Northeast Georgia Medical Center Gainesville
Gainesville, Georgia 30501
United StatesActive - Recruiting
Parkview Research Center
Fort Wayne, Indiana 46845
United StatesActive - Recruiting
Community Health Network, Inc.
Indianapolis, Indiana 46250
United StatesSite Not Available
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
University of Iowa Hospital and Clinics
Iowa City, Iowa 52242-1009
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Trials365, Llc
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Trials365, Llc
Shreveport 4341513, Louisiana 4331987 71133
United StatesSite Not Available
Greater Baltimore Medical Center
Baltimore, Maryland 21204
United StatesActive - Recruiting
John Hopkins University-School of Medicine
Baltimore, Maryland 21287
United StatesSite Not Available
Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Umass Memorial Medical Center, Inc.
Worcester, Massachusetts 01605
United StatesSite Not Available
University of Michigan Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesSite Not Available
Minnesota Oncology-Minneapolis
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Washington University
St Louis, Missouri 63110
United StatesActive - Recruiting
St. Vincent Regional Hospital - West End Clinic
Billings, Montana 59106
United StatesActive - Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesActive - Recruiting
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
United StatesActive - Recruiting
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York 14642
United StatesSite Not Available
State University of New York Upstate Medical Unive
Syracuse, New York 13210
United StatesSite Not Available
Oncology Hematology Care, Inc
Cincinnati, Ohio 45242
United StatesActive - Recruiting
The Mark H Zangmeister Cancer Center Ohio
Columbus, Ohio 43219
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
Hilliard, Ohio 43026
United StatesActive - Recruiting
Penn State College of Medicine
Hershey, Pennsylvania 17033
United StatesSite Not Available
Asplundh Cancer Pavilion - Thomas Jefferson
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Texas Oncology-Austin Center
Austin, Texas 78731
United StatesActive - Recruiting
Houston Methodist Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Cancer Care Center of South Texas-Medical Center
San Antonio, Texas 78229
United StatesActive - Recruiting
Texas Oncology-San Antonio Medical Center Pharmacy
San Antonio, Texas 78229
United StatesActive - Recruiting
Texas Oncology-Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
Utah Cancer Specialists
Salt Lake City, Utah 84106
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
Virginia Cancer Specialists, Pc
Fairfax, Virginia 22031
United StatesActive - Recruiting
Carilion Clinic
Roanoke, Virginia 24016-4962
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesActive - Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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