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
NCT ID: NCT02631876
Last Updated: 2020-10-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
366 participants
INTERVENTIONAL
2016-03-02
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT04606914
Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer
NCT02606305
Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer
NCT05456685
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT03552471
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
NCT04209855
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mirvetuximab Soravtansine
Participants will receive mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants will continue to receive study drug until they experience progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee \[BIRC\]), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 86.9 weeks)
Mirvetuximab soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
Investigator's Choice (IC) Chemotherapy
Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel will be administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan will be administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin will be administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion. Participants will continue to receive study drug until they experience PD per RECIST version 1.1 (as assessed by BIRC), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 62.9 weeks)
Paclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Topotecan
Topotecan will be administered per dose and schedule specified in the arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirvetuximab soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
Paclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Topotecan
Topotecan will be administered per dose and schedule specified in the arm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gynecologic Oncology Group
NETWORK
ImmunoGen, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
CMO ImmunoGen
Role: STUDY_DIRECTOR
ImmunoGen, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
UCLA Women's Health Clinical Research Unit - OBGYN
Los Angeles, California, United States
University of California San Diego Medical Center
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Norwalk Hospital/WCHN
Norwalk, Connecticut, United States
Florida State University College of Medicine
Sarasota, Florida, United States
Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Sudarshan Sharma LTD
Hinsdale, Illinois, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Women's Cancer Care
Covington, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
WK Physician Network Clinical Research
Shreveport, Louisiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mercy Women's Oncology
Springfield, Missouri, United States
Center of Hope
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
MD Anderson Cancer Center - Cooper Health
Camden, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center
Albuquerque, New Mexico, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)
New York, New York, United States
Levine Cancer Institute - Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Fairview Hospital, Moll Pavilion Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Hillcrest Hospital
Mayfield, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Women & Infants of Rhode Island
Providence, Rhode Island, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Texas Oncology-Austin Central
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Kadlec Clinic Hematology & Oncology
Kennewick, Washington, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
AZ Groeninge - Oncology Centre
Kortrijk, , Belgium
Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg
Leuven, , Belgium
Centre Hospitalier de l'Ardenne
Libramont, , Belgium
University Clinical Center of Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute - Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hopital de la CitedelaSante
Laval, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Porodnicka A Gynekologicka Klinika
Hradec Králové, , Czechia
University Hospital Ostrava
Ostrava Poruba, , Czechia
Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin
Zlín, , Czechia
Institut de Cancerologie de L'Ouest - site Paul Papin
Angers, , France
CHRU Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Cochin Hospital
Paris, , France
Hôpital Croix St-Simon
Paris, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol
Plérin, , France
Centre Eugene Marquis
Rennes, , France
Institut Curie-Hopital Rene Huguenin
Saint-Cloud, , France
Institut Claudius Regaud
Toulouse, , France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, , France
Gustave Roussy Institution
Villejuif, , France
Bon Secours Hospital
Cork, , Ireland
Mater Private Hospital and Mater Misericordiae University Hospital
Dublin, , Ireland
Istituto Europeo di Oncologia
Milan, MI, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Sanitaria Locale (ASL)
Brindisi, , Italy
Azienda Unita Sanitaria Locale di Ravenna
Faenza, , Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC), , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS National Cancer Institute
Milan, , Italy
Istituto Nazionale Tumori- G. Pascale
Naples, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
LLC "VitaMed"
Moscow, , Russia
State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"
Novosibirsk, , Russia
Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"
Omsk, , Russia
State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"
Saint Petersburg, , Russia
Oncology and Radiology Institute Serbia
Belgrade, , Serbia
Oncology Institute Vojvodina
Kamenitz, , Serbia
Clinical Centre Nis, Oncology Clinic
Niš, , Serbia
ICO Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Onkologikoa
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Teresa Herrera (CHUACoruña)
A Coruña, , Spain
IOR - Hospital Quiron Dexeus
Barcelona, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Institut Català d'Oncologia - Unitad de Investigación Clínica
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Complejo Hospitalario Granada
Granada, , Spain
Hospital Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center - Madrid
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Servicio de Oncología Médica Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga
Málaga, , Spain
Hospital Son Llatzer (HSLL)
Palma de Mallorca, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, Canton of Zurich, Switzerland
Kantonsspital
Winterthur, Canton of Zurich, Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
UCL Cancer Institute
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, England, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, England, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)
Sutton, England, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW
Wolverhampton, England, United Kingdom
Peterborough City Hospital
Peterborough, Great Britain, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University
Stoke-on-Trent, Staffordshire, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre
Coventry, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMGN853-0403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.