Phase
Condition
Fallopian Tube Cancer
Ovarian Cysts
Pelvic Cancer
Treatment
Upifitimab rilsodotin
Placebo
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant must have a histological diagnosis of high grade serous ovarian cancer,which includes fallopian tube and primary peritoneal cancer, that is metastatic orrecurrent.
- Participant must have platinum-sensitive recurrent disease, defined as having achievedeither a partial or complete response to 4 or more cycles in their penultimateplatinum- containing regimen and their disease progressing more than 6 months aftercompletion of the last dose of platinum containing therapy in the penultimate regimen.
- Participant must have had 4 to 8 cycles of platinum-based chemotherapy in 2nd to 4thline setting in their most recent treatment regimen as defined below:
- Platinum-based chemotherapy regimens allowed immediately preceding enrollment tothe study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomaldoxorubicin or gemcitabine.
- Participant must receive first study treatment infusion between 4 and 12 weeksafter completing final dose of platinum in the most recent platinum-basedregimen.
- Participant must have had as their best response to last line of treatment one of thefollowing: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD)
- Participants with NED, CR, or PR as their best response to most recent line oftreatment and who have not received treatment with a prior PARP inhibitor must havedefinitive BRCA1 and BRCA2 testing results that demonstrate no evidence of adeleterious BRCA1 or BRCA2 mutation. Somatic BRCA mutation testing is required forparticipants who are classified as not having a deleterious mutation by germlinetesting alone.
- Participant must provide either a tumor tissue block or fresh cut slides formeasurement of NaPi2b expression by a central laboratory. If sufficient archival tumortissue is not available, then a tumor tissue block or slides must be obtained from afresh biopsy and provided to the central laboratory. Confirmation of aNaPi2b-H/positive tumor by the central laboratory is required prior to randomization.
Exclusion
Exclusion Criteria:
- Participant has received prior treatment with mirvetuximab soravtansine or another ADCcontaining an auristatin or maytansinoid payload.
- Participant has received bevacizumab in combination with last platinum-based regimentor plans to receive maintenance therapy outside the study intervention.
- Participant has clinical signs or symptoms of gastrointestinal obstruction and/orrequirement for parenteral hydration or nutrition.
- Participant has ascites or pleural effusion managed with therapeutic paracentesis orthoracentesis within 28 days prior to signing the principal study consent form.
- Participant has history of cirrhosis, hepatic fibrosis, esophageal or gastric varices,or other clinically significant liver disease. Testing beyond laboratory studiesotherwise defined in the eligibility criteria, to diagnose potentially clinicallysignificant liver disease based on risk factors such as hepatic steatosis or historyof excessive alcohol intake, will be based on clinical judgement of the investigator.
- Participant has history of or suspected pneumonitis or interstitial lung disease.
- Participant has untreated CNS metastases (including new and progressive brainmetastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
Study Design
Study Description
Connect with a study center
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
AustraliaSite Not Available
Icon Cancer Centre - Chermside
Chermside, Queensland 4032
AustraliaSite Not Available
Icon Cancer Centre Southport
Southport, Queensland 4125
AustraliaSite Not Available
Epworth Richmond
Richmond, Victoria 3121
AustraliaSite Not Available
CHUM - University of Montreal Hospital Centre
Montréal, Quebec H2X 3E4
CanadaSite Not Available
Sherbrooke University Hospital Centre
Quebec, Sherbrooke J1H 5N4
CanadaSite Not Available
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
HonorHealth Research Institute - HonorHealth VGPCC Biltmore
Phoenix, Arizona 85016
United StatesSite Not Available
The University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
University of California Los Angeles, Gynecologic Oncology Clinic
Los Angeles, California 90095
United StatesSite Not Available
University of California, Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80012
United StatesSite Not Available
Miami Valley Hospital South
Miami, Florida 45459
United StatesSite Not Available
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesSite Not Available
Orlando Health, Inc.
Orlando, Florida 32806
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
Tampa General Hospital
Tampa, Florida 33606
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Northeast Georgia Medical Center
Gainesville, Georgia 30501
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Gyne Oncology Clinic
Hinsdale, Illinois 60521
United StatesSite Not Available
Community Health Network, Community Cancer Center North
Indianapolis, Indiana 46250
United StatesSite Not Available
WK Physicians
Shreveport, Louisiana 71103
United StatesSite Not Available
Maine Medical Partners, Division of Gynecologic Oncology
Scarborough, Maine 04074
United StatesSite Not Available
Greater Baltimore Medical Center
Towson, Maryland 21204
United StatesSite Not Available
Mersana Therapeutics
Cambridge, Massachusetts 02139
United StatesSite Not Available
Karmanos Cancer Institute - Detroit
Detroit, Michigan 48201
United StatesSite Not Available
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota 55404
United StatesSite Not Available
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri 64132
United StatesSite Not Available
Washington University School of Medicine, Center for Advanced Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Cox Medical Centers, GYN ONC
Springfield, Missouri 65807
United StatesSite Not Available
Billings Clinic
Billings, Montana 59101
United StatesSite Not Available
Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United StatesSite Not Available
Center of Hope
Reno, Nevada 89433
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Hackensack University Medical Center, John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesSite Not Available
Southwest Women's Oncology
Albuquerque, New Mexico 87109
United StatesSite Not Available
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United StatesSite Not Available
The Blavatnik Family at Chelsea Medical Center at Mount Sinai
New York, New York 10011
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Vidant Cancer Center - at Vidant Medical Center
Greenville, North Carolina 27834
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic - Cleveland
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio 44106
United StatesSite Not Available
OSU Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United StatesSite Not Available
Kettering Health Cancer Center
Kettering, Ohio 45429
United StatesSite Not Available
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401
United StatesSite Not Available
Legacy Good Samaritan Medical Center - Legacy Medical Group - Gynecologic Oncology
Portland, Oregon 97210
United StatesSite Not Available
Northwest Cancer Specialists PC
Portland, Oregon 97227
United StatesSite Not Available
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Allegheny Health Network Cancer Institute, West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
Women and Infants Hospital
Providence, Rhode Island 02905
United StatesSite Not Available
Hollings Cancer Center (HCC)
Charleston, South Carolina 29425
United StatesSite Not Available
Avera McKennan d/b/a Avera Research Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sanford Gynecologic Oncology
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Erlanger Womens Oncology
Chattanooga, Tennessee 37403
United StatesSite Not Available
Texas Oncology P.A. - Austin
Austin, Texas 78745
United StatesSite Not Available
Texas Oncology - DFWW
Bedford, Texas 76022
United StatesSite Not Available
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas 75231
United StatesSite Not Available
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas 76006
United StatesSite Not Available
Texas Oncology P.A. - McAllen
McAllen, Texas 78503
United StatesSite Not Available
Texas Oncology - Tyler
Tyler, Texas 75702
United StatesSite Not Available
VCU Massey Cancer Center
Richmond, Virginia 23291
United StatesSite Not Available
Carilion Clinic Gynecological Oncology
Roanoke, Virginia 24016
United StatesSite Not Available
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesSite Not Available
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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