Ovarian Cancer Clinical Trial
A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
Summary
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.
Full Description
Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Participants must be diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
Participants must have folate receptor alpha positive tumor expression as defined in the protocol
Participants must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
Participants must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
Participants must have at least one lesion that meets the definition of measurable disease by RECIST 1.1
Exclusion Criteria:
Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
Participants with primary platinum-refractory disease
Serious concurrent illness or clinically relevant active infection as defined in the protocol
Prior treatment with mirvetuximab soravtansine
Women who are pregnant or breast feeding
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There are 128 Locations for this study
Birmingham Alabama, 35294, United States
Tempe Arizona, 85284, United States
Tucson Arizona, 85711, United States
Los Angeles California, 90095, United States
San Diego California, 92093, United States
San Francisco California, 94118, United States
Vallejo California, 94589, United States
New Haven Connecticut, 06520, United States
Norwalk Connecticut, 06856, United States
Sarasota Florida, 34239, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60629, United States
Hinsdale Illinois, 60521, United States
Indianapolis Indiana, 46184, United States
Indianapolis Indiana, 46202, United States
Louisville Kentucky, 40241, United States
Covington Louisiana, 70433, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71101, United States
Silver Spring Maryland, 20902, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Worcester Massachusetts, 01605, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Springfield Missouri, 65804, United States
Reno Nevada, 89502, United States
Lebanon New Hampshire, 03756, United States
Camden New Jersey, 08103, United States
Summit New Jersey, 07901, United States
Albuquerque New Mexico, 87131, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Mayfield Ohio, 44124, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Austin Texas, 78731, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Kennewick Washington, 99336, United States
Milwaukee Wisconsin, 53226, United States
Brussels , 1200, Belgium
Kortrijk , 8500, Belgium
Leuven , B-300, Belgium
Libramont , 6800, Belgium
Banja Luka , 78 00, Bosnia and Herzegovina
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H8L, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H2X 0, Canada
Montréal Quebec, H4A 3, Canada
Hradec Králové , 500 0, Czechia
Ostrava Poruba , 708 5, Czechia
ZlÃn , 76275, Czechia
Angers , 49055, France
Besançon , 25030, France
Bordeaux , 33076, France
Paris , 75014, France
Paris , 75020, France
Pierre-Bénite , 69495, France
Plérin , 22190, France
Rennes , 35042, France
Saint-Cloud , 92210, France
Toulouse , 31059, France
Vandœuvre-lès-Nancy , 54519, France
Villejuif , 94800, France
Cork , , Ireland
Dublin , , Ireland
Milano MI, 20141, Italy
Bologna , 40138, Italy
Brindisi , 72100, Italy
Faenza , 48018, Italy
Meldola (FC) , 47014, Italy
Milan , 20132, Italy
Milan , 20133, Italy
Naples , 80131, Italy
Roma , 00168, Italy
Moscow , 12130, Russian Federation
Novosibirsk , 63010, Russian Federation
Omsk , 64401, Russian Federation
Saint Petersburg , 19101, Russian Federation
Belgrade , 11 00, Serbia
Niš , 18 00, Serbia
Sremska Kamenica , 21 20, Serbia
Badalona Barcelona, 08916, Spain
Donostia San Sebastian Gipuzkoa, 20014, Spain
A Coruña , 15006, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Córdoba , 14004, Spain
Granada , 18014, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Malaga , 29011, Spain
Palma de Mallorca , 07198, Spain
Valencia , 46009, Spain
Winterthur Zurich, 8401, Switzerland
Winterthur Zurich, 8401, Switzerland
Geneve , 1205, Switzerland
London England, WC1E , United Kingdom
Manchester England, M20 4, United Kingdom
Nottingham England, NG5 1, United Kingdom
Preston England, PR2 9, United Kingdom
Sutton England, SM2 5, United Kingdom
Wolverhampton England, WV10 , United Kingdom
Peterborough Great Britain, PE3 9, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Coventry , CV2 2, United Kingdom
Northwood , HA6 2, United Kingdom
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