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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 (FORWARD I)

Primary Purpose

Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirvetuximab soravtansine
Paclitaxel
Pegylated liposomal doxorubicin
Topotecan
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, IMGN853, ADC, Antibody drug conjugate, ImmunoGen, Antibody, Folate receptor alpha, mirvetuximab soravtansine, Phase 3, platinum-resistant, MIRV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology Associates, PC - HOPE
  • UCLA Women's Health Clinical Research Unit - OBGYN
  • University of California San Diego Medical Center
  • California Pacific Medical Center
  • Kaiser Permanente Medical Center
  • Yale University School of Medicine
  • Norwalk Hospital/WCHN
  • Florida State University College of Medicine
  • Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center
  • Rush University Medical Center
  • Sudarshan Sharma LTD
  • Community Health Network, Inc.
  • Indiana University School of Medicine
  • Norton Cancer Institute
  • Women's Cancer Care
  • Ochsner Clinic Foundation
  • WK Physician Network Clinical Research
  • Holy Cross Hospital
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • University of Massachusetts Memorial Medical Center
  • Karmanos Cancer Institute
  • Henry Ford Hospital
  • Mercy Women's Oncology
  • Center of Hope
  • Dartmouth-Hitchcock Medical Center
  • MD Anderson Cancer Center - Cooper Health
  • Overlook Medical Center
  • The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)
  • Levine Cancer Institute - Carolinas Medical Center
  • University of Cincinnati Medical Center
  • Fairview Hospital, Moll Pavilion Cancer Center
  • Cleveland Clinic
  • OSU Wexner Medical Center
  • Hillcrest Hospital
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute, LLC
  • University of Pennsylvania
  • Magee - Womens Hospital of UPMC
  • Women & Infants of Rhode Island
  • Hollings Cancer Center
  • Texas Oncology-Austin Central
  • University of Texas Southwestern Medical Center
  • Texas Oncology - Fort Worth
  • Texas Oncology - The Woodlands, Gynecologic Oncology
  • Texas Oncology-Tyler
  • Kadlec Clinic Hematology & Oncology
  • Froedtert and Medical College of Wisconsin
  • Cliniques Universitaires Saint-Luc
  • AZ Groeninge - Oncology Centre
  • Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg
  • Centre Hospitalier de l'Ardenne
  • University Clinical Center of Republic of Srpska
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Juravinski Cancer Centre
  • London Health Sciences Centre
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook Research Institute - Odette Cancer Centre
  • Princess Margaret Cancer Centre
  • Hopital de la CitedelaSante
  • Centre hospitalier de l'Université de Montréal
  • McGill University Health Centre - Glen Site
  • Porodnicka A Gynekologicka Klinika
  • University Hospital Ostrava
  • Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin
  • Institut de Cancerologie de L'Ouest - site Paul Papin
  • CHRU Jean Minjoz
  • Institut Bergonie
  • Cochin Hospital
  • Hôpital Croix St-Simon
  • Centre Hospitalier Lyon-Sud
  • Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol
  • Centre Eugene Marquis
  • Institut Curie-Hopital Rene Huguenin
  • Institut Claudius Regaud
  • Institut de Cancerologie de Lorraine
  • Gustave Roussy Institution
  • Bon Secours Hospital
  • Mater Private Hospital and Mater Misericordiae University Hospital
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • Azienda Sanitaria Locale (ASL)
  • Azienda Unita Sanitaria Locale di Ravenna
  • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
  • Ospedale San Raffaele
  • Fondazione IRCCS National Cancer Institute
  • Istituto Nazionale Tumori- G. Pascale
  • Policlinico Universitario Agostino Gemelli
  • LLC "VitaMed"
  • State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"
  • Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"
  • State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"
  • Oncology and Radiology Institute Serbia
  • Clinical Centre Nis, Oncology Clinic
  • Oncology Institute Vojvodina
  • ICO Hospital Germans Trias i Pujol
  • Onkologikoa
  • Hospital Teresa Herrera (CHUACoruña)
  • IOR - Hospital Quiron Dexeus
  • Hospital Vall D'Hebron
  • Institut Català d'Oncologia - Unitad de Investigación Clínica
  • Hospital Reina Sofia
  • Complejo Hospitalario Granada
  • Hospital Universitario Gregorio Maranon
  • MD Anderson Cancer Center - Madrid
  • Hospital Universitario Ramon Y Cajal
  • Servicio de Oncología Médica Hospital Universitario La Paz
  • Hospital Universitario HM Sanchinarro
  • Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga
  • Hospital Son Llatzer (HSLL)
  • Instituto Valenciano de Oncologia
  • Kantonsspital Winterthur, Medizinische Onkologie
  • Kantonsspital
  • Hopitaux Universitaires de Geneve
  • UCL Cancer Institute
  • The Christie NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust - City Hospital
  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)
  • The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW
  • Peterborough City Hospital
  • Beatson West of Scotland Cancer Centre
  • Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University
  • University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre
  • Mount Vernon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mirvetuximab Soravtansine

Investigator's Choice (IC) Chemotherapy

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Secondary Outcome Measures

Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the SoD of target lesions, taking as reference the baseline SoD.
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death from any cause. Participants who did not experience the event of death were censored at their last date known to be alive. OS was estimated using the Kaplan-Meier method.
Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28-item ovarian cancer supplemental module. It comprises of 6 symptom scales (AB/GI symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease, treatment), and sexual functioning. Participants were asked to indicate extent to which they experienced AB/GI symptoms. Participants responded on a scale of 1-4(1=not at all, 2=a little, 3=quite a bit, 4=very much) to following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data were transformed to a scale from 0-100. Lower scores=better health.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE): any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity: graded per National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Relation of AE to treatment was determined by investigator. Serious AEs: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: any AE that emerged on or after the first dose, and within 30 days of the last dose. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported AEs module.
Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.
PFS, as Assessed by Investigator Per RECIST Version 1.1
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1
DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of PD. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4
PK parameters were calculated using standard non-compartmental methods.
Number of Participants With Anti-Drug Antibodies (ADA)
An electrochemiluminescent method was used for the detection of anti-mirvetuximab soravtansine antibodies in plasma from samples collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) tubes. The qualitative assay was designed to detect anti-mirvetuximab soravtansine antibodies in human plasma.

Full Information

First Posted
December 10, 2015
Last Updated
September 24, 2020
Sponsor
ImmunoGen, Inc.
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02631876
Brief Title
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
Acronym
FORWARD I
Official Title
FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.
Collaborators
Gynecologic Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Ovarian Cancer
Keywords
Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, IMGN853, ADC, Antibody drug conjugate, ImmunoGen, Antibody, Folate receptor alpha, mirvetuximab soravtansine, Phase 3, platinum-resistant, MIRV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirvetuximab Soravtansine
Arm Type
Experimental
Arm Description
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)
Arm Title
Investigator's Choice (IC) Chemotherapy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Mirvetuximab soravtansine
Intervention Description
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered per dose and schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin
Intervention Description
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan will be administered per dose and schedule specified in the arm.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study
Description
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame
From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)
Description
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame
From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1
Description
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the SoD of target lesions, taking as reference the baseline SoD.
Time Frame
From randomization until first BOR of CR or PR (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization until the date of death from any cause. Participants who did not experience the event of death were censored at their last date known to be alive. OS was estimated using the Kaplan-Meier method.
Time Frame
From the date of randomization until the time of death (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment
Description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28-item ovarian cancer supplemental module. It comprises of 6 symptom scales (AB/GI symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease, treatment), and sexual functioning. Participants were asked to indicate extent to which they experienced AB/GI symptoms. Participants responded on a scale of 1-4(1=not at all, 2=a little, 3=quite a bit, 4=very much) to following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data were transformed to a scale from 0-100. Lower scores=better health.
Time Frame
Baseline, Week 8/9
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Adverse event (AE): any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity: graded per National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Relation of AE to treatment was determined by investigator. Serious AEs: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: any AE that emerged on or after the first dose, and within 30 days of the last dose. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported AEs module.
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
Description
CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.
Time Frame
From first dose of study drug until CA-125 response (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
PFS, as Assessed by Investigator Per RECIST Version 1.1
Description
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame
From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1
Description
DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of PD. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
Time Frame
From the date of first response (CR or PR) until the date of PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
Title
Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4
Description
PK parameters were calculated using standard non-compartmental methods.
Time Frame
Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; and Day 8 and 15 of Cycles 1 and 3
Title
Number of Participants With Anti-Drug Antibodies (ADA)
Description
An electrochemiluminescent method was used for the detection of anti-mirvetuximab soravtansine antibodies in plasma from samples collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) tubes. The qualitative assay was designed to detect anti-mirvetuximab soravtansine antibodies in human plasma.
Time Frame
Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1, 2, and 4; pre-dose on Day 1 of Cycle 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CMO ImmunoGen
Organizational Affiliation
ImmunoGen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
UCLA Women's Health Clinical Research Unit - OBGYN
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Norwalk Hospital/WCHN
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Florida State University College of Medicine
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60629
Country
United States
Facility Name
Sudarshan Sharma LTD
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46184
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Women's Cancer Care
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
WK Physician Network Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mercy Women's Oncology
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Center of Hope
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
MD Anderson Cancer Center - Cooper Health
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute - Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Fairview Hospital, Moll Pavilion Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OSU Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hillcrest Hospital
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Magee - Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Women & Infants of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology-Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology - The Woodlands, Gynecologic Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Kadlec Clinic Hematology & Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Groeninge - Oncology Centre
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
University Clinical Center of Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78 000
Country
Bosnia and Herzegovina
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Sunnybrook Research Institute - Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital de la CitedelaSante
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
McGill University Health Centre - Glen Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Porodnicka A Gynekologicka Klinika
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin
City
Zlín
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Institut de Cancerologie de L'Ouest - site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHRU Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Croix St-Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Curie-Hopital Rene Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Gustave Roussy Institution
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Bon Secours Hospital
City
Cork
Country
Ireland
Facility Name
Mater Private Hospital and Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Sanitaria Locale (ASL)
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Azienda Unita Sanitaria Locale di Ravenna
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS National Cancer Institute
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori- G. Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
LLC "VitaMed"
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"
City
Saint Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Oncology and Radiology Institute Serbia
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinical Centre Nis, Oncology Clinic
City
Niš
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Oncology Institute Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21 204
Country
Serbia
Facility Name
ICO Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Onkologikoa
City
Donostia San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Teresa Herrera (CHUACoruña)
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
IOR - Hospital Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Català d'Oncologia - Unitad de Investigación Clínica
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario Granada
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Center - Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Servicio de Oncología Médica Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Son Llatzer (HSLL)
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Kantonsspital Winterthur, Medizinische Onkologie
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Kantonsspital
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 OQP
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
State/Province
Great Britain
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33667670
Citation
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.
Results Reference
derived

Learn more about this 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

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