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.

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Full Description

Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

366

Study ID:

NCT02631876

Recruitment Status:

Completed

Sponsor:

ImmunoGen, Inc.

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There are 128 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Arizona Oncology Associates, PC - HAL
Tempe Arizona, 85284, United States
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85711, United States
UCLA Women's Health Clinical Research Unit - OBGYN
Los Angeles California, 90095, United States
University of California San Diego Medical Center
San Diego California, 92093, United States
California Pacific Medical Center
San Francisco California, 94118, United States
Kaiser Permanente Medical Center
Vallejo California, 94589, United States
Yale University School of Medicine
New Haven Connecticut, 06520, United States
Norwalk Hospital/WCHN
Norwalk Connecticut, 06856, United States
Florida State University College of Medicine
Sarasota Florida, 34239, United States
Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center
Augusta Georgia, 30912, United States
Rush University Medical Center
Chicago Illinois, 60629, United States
Sudarshan Sharma LTD
Hinsdale Illinois, 60521, United States
Community Health Network, Inc.
Indianapolis Indiana, 46184, United States
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States
Norton Cancer Institute
Louisville Kentucky, 40241, United States
Women's Cancer Care
Covington Louisiana, 70433, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
WK Physician Network Clinical Research
Shreveport Louisiana, 71101, United States
Holy Cross Hospital
Silver Spring Maryland, 20902, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01605, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Mercy Women's Oncology
Springfield Missouri, 65804, United States
Center of Hope
Reno Nevada, 89502, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
MD Anderson Cancer Center - Cooper Health
Camden New Jersey, 08103, United States
Overlook Medical Center
Summit New Jersey, 07901, United States
The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center
Albuquerque New Mexico, 87131, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)
New York New York, 10065, United States
Levine Cancer Institute - Carolinas Medical Center
Charlotte North Carolina, 28204, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, United States
Fairview Hospital, Moll Pavilion Cancer Center
Cleveland Ohio, 44111, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
OSU Wexner Medical Center
Columbus Ohio, 43210, United States
Hillcrest Hospital
Mayfield Ohio, 44124, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa Oklahoma, 74146, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Magee - Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
Women & Infants of Rhode Island
Providence Rhode Island, 02905, United States
Hollings Cancer Center
Charleston South Carolina, 29425, United States
Texas Oncology-Austin Central
Austin Texas, 78731, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Texas Oncology - Fort Worth
Fort Worth Texas, 76104, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands Texas, 77380, United States
Texas Oncology-Tyler
Tyler Texas, 75702, United States
Kadlec Clinic Hematology & Oncology
Kennewick Washington, 99336, United States
Froedtert and Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
AZ Groeninge - Oncology Centre
Kortrijk , 8500, Belgium
Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg
Leuven , B-300, Belgium
Centre Hospitalier de l'Ardenne
Libramont , 6800, Belgium
University Clinical Center of Republic of Srpska
Banja Luka , 78 00, Bosnia and Herzegovina
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H8L, Canada
Sunnybrook Research Institute - Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital de la CitedelaSante
Laval Quebec, H7M 3, Canada
Centre hospitalier de l'Université de Montréal
Montreal Quebec, H2X 0, Canada
McGill University Health Centre - Glen Site
Montréal Quebec, H4A 3, Canada
Porodnicka A Gynekologicka Klinika
Hradec Králové , 500 0, Czechia
University Hospital Ostrava
Ostrava Poruba , 708 5, Czechia
Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin
Zlín , 76275, Czechia
Institut de Cancerologie de L'Ouest - site Paul Papin
Angers , 49055, France
CHRU Jean Minjoz
Besançon , 25030, France
Institut Bergonie
Bordeaux , 33076, France
Cochin Hospital
Paris , 75014, France
Hôpital Croix St-Simon
Paris , 75020, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite , 69495, France
Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol
Plérin , 22190, France
Centre Eugene Marquis
Rennes , 35042, France
Institut Curie-Hopital Rene Huguenin
Saint-Cloud , 92210, France
Institut Claudius Regaud
Toulouse , 31059, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy , 54519, France
Gustave Roussy Institution
Villejuif , 94800, France
Bon Secours Hospital
Cork , , Ireland
Mater Private Hospital and Mater Misericordiae University Hospital
Dublin , , Ireland
Istituto Europeo di Oncologia
Milano MI, 20141, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Azienda Sanitaria Locale (ASL)
Brindisi , 72100, Italy
Azienda Unita Sanitaria Locale di Ravenna
Faenza , 48018, Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC) , 47014, Italy
Ospedale San Raffaele
Milan , 20132, Italy
Fondazione IRCCS National Cancer Institute
Milan , 20133, Italy
Istituto Nazionale Tumori- G. Pascale
Naples , 80131, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
LLC "VitaMed"
Moscow , 12130, Russian Federation
State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"
Novosibirsk , 63010, Russian Federation
Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation
State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"
Saint Petersburg , 19101, Russian Federation
Oncology and Radiology Institute Serbia
Belgrade , 11 00, Serbia
Clinical Centre Nis, Oncology Clinic
Niš , 18 00, Serbia
Oncology Institute Vojvodina
Sremska Kamenica , 21 20, Serbia
ICO Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Onkologikoa
Donostia San Sebastian Gipuzkoa, 20014, Spain
Hospital Teresa Herrera (CHUACoruña)
A Coruña , 15006, Spain
IOR - Hospital Quiron Dexeus
Barcelona , 08028, Spain
Hospital Vall D'Hebron
Barcelona , 08035, Spain
Institut Català d'Oncologia - Unitad de Investigación Clínica
Barcelona , 08908, Spain
Hospital Reina Sofia
Córdoba , 14004, Spain
Complejo Hospitalario Granada
Granada , 18014, Spain
Hospital Universitario Gregorio Maranon
Madrid , 28007, Spain
MD Anderson Cancer Center - Madrid
Madrid , 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Servicio de Oncología Médica Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga
Malaga , 29011, Spain
Hospital Son Llatzer (HSLL)
Palma de Mallorca , 07198, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur Zurich, 8401, Switzerland
Kantonsspital
Winterthur Zurich, 8401, Switzerland
Hopitaux Universitaires de Geneve
Geneve , 1205, Switzerland
UCL Cancer Institute
London England, WC1E , United Kingdom
The Christie NHS Foundation Trust
Manchester England, M20 4, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham England, NG5 1, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston England, PR2 9, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)
Sutton England, SM2 5, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW
Wolverhampton England, WV10 , United Kingdom
Peterborough City Hospital
Peterborough Great Britain, PE3 9, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow Scotland, G12 0, United Kingdom
Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre
Coventry , CV2 2, United Kingdom
Mount Vernon Cancer Centre
Northwood , HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

366

Study ID:

NCT02631876

Recruitment Status:

Completed

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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