Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    FORWARD 1: 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 α−positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

    Summary
    EudraCT number
    		 2015-004060-11
    Trial protocol
    		 ES   GB   BE   PL   BG   IT  
    Global end of trial date
    21 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2021
    First version publication date
    19 Feb 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IMGN853-0403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02631876
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ImmunoGen, Inc.
    Sponsor organisation address
    830 Winter Street, Waltham, United States, MA 02451
    Public contact
    CMO, ImmunoGen, ImmunoGen, Inc., +1 781-895-0600, clinicaltrials@immunogen.com
    Scientific contact
    CMO, ImmunoGen, ImmunoGen, Inc., +1 781-895-0600, clinicaltrials@immunogen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the progression-free survival (PFS) of participants randomized to mirvetuximab soravtansine versus selected standard of care chemotherapy.
    Protection of trial subjects
    This study was designed and monitored in accordance with sponsor requirements, which comply with the ethical principles of ICH E6 Good Clinical Practice as required by the country-specific health authorities, and in accordance with principles laid out in the Declaration of Helsinki. The protocol also complied with the laws and regulations, as well as any applicable guidelines, of the countries in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 57
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Ireland: 13
    Country: Number of subjects enrolled
    Canada: 48
    Country: Number of subjects enrolled
    Italy: 73
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Ukraine: 4
    Country: Number of subjects enrolled
    United States: 112
    Worldwide total number of subjects
    366
    EEA total number of subjects
    191
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    194
    From 65 to 84 years
    169
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted in participants with folate receptor alpha-positive, platinum-resistant epithelial ovarian cancer at 101 sites in 12 countries between 02 March 2016 and 21 January 2020. Participants who had received 1-3 prior systemic lines of anti-cancer therapy and who fulfilled the eligibility criteria were enrolled.

    Pre-assignment
    Screening details
    		 A total of 366 participants were randomized in a ratio of 2:1 to receive either mirvetuximab soravtansine or the investigator’s choice of chemotherapy.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mirvetuximab Soravtansine
    Arm description
    		 Participants received 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 continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirvetuximab soravtansine
    Investigational medicinal product code
    IMGN853
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mirvetuximab Soravtansine was administered per dose and schedule specified in the arm description.

    Arm title
    		 Investigator’s Choice (IC) Chemotherapy
    Arm description
    		 Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel 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 administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin (PLD) 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, PLD could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered per dose and schedule specified in the arm description.

    Investigational medicinal product name
    Pegylated liposomal doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    PLD was administered per dose and schedule specified in the arm description.

    Investigational medicinal product name
    Topotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Topotecan was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1
    		Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Started
    248
    118
    Safety Population
    243
    109
    Completed
    129
    55
    Not completed
    119
    63
         Physician decision
    1
    -
         Consent withdrawn by subject
    16
    9
         Death
    96
    50
         Other than specified
    4
    4
         Lost to follow-up
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Mirvetuximab Soravtansine
    Reporting group description
    		 Participants received 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 continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Reporting group title
    Investigator’s Choice (IC) Chemotherapy
    Reporting group description
    		 Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel 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 administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin (PLD) 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, PLD could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Reporting group values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy Total
    Number of subjects
    		 248 118 366
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ( 10.29 ) 62.9 ( 10.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 248 118 366
        Male
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 9 21
        Not Hispanic or Latino
    		 225 102 327
        Unknown or Not Reported
    		 11 7 18
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 6 2 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 7 3 10
        White
    		 225 105 330
        Other
    		 2 2 4
        Unknown or Not Reported
    		 8 5 13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Mirvetuximab Soravtansine
    Reporting group description
    		 Participants received 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 continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Reporting group title
    Investigator’s Choice (IC) Chemotherapy
    Reporting group description
    		 Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel 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 administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin (PLD) 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, PLD could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Primary: PFS, as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study

    		 Close Top of page
    End point title
    		 PFS, as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study [1]
    End point description
    PFS was defined as the time from randomization until PD or death from any cause, 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 lesions, 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. The intent-to-treat (ITT) population included all participants randomized in the study.
    End point type
    Primary
    End point timeframe
    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)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    248
    118
    Units: months
        median (confidence interval 95%)
    4.14 (3.75 to 4.53)
    4.44 (2.83 to 5.59)
    No statistical analyses for this end point

    Primary: PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)

    		 Close Top of page
    End point title
    		 PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) [2]
    End point description
    PFS was defined as the time from randomization until PD or death from any cause, whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesions, 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. The ITT population included all participants randomized in the study. Here, the 'number of subjects analysed' signifies participants with high folate receptor alpha level.
    End point type
    Primary
    End point timeframe
    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)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    147
    71
    Units: months
        median (confidence interval 95%)
    4.76 (4.11 to 5.68)
    3.25 (1.97 to 5.59)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST Version 1.1

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST Version 1.1
    End point 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. The ITT population included all participants randomized in the study.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    248
    118
    Units: Percentage of participants
        number (confidence interval 95%)
    22 (17.2 to 27.9)
    12 (6.6 to 19.1)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point 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. The ITT population included all participants randomized in the study.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    248
    118
    Units: months
        median (confidence interval 95%)
    15.57 (12.85 to 18.04)
    13.93 (11.40 to 18.50)
    No statistical analyses for this end point

    Secondary: 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

    		 Close Top of page
    End point 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
    End point description
    The 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. ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/9
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    142
    50
    Units: Participants
    45
    7
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    		 Close Top of page
    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    End point 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. 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 AEs module. The safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    243
    109
    Units: Participants
    242
    107
    No statistical analyses for this end point

    Secondary: Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses

    		 Close Top of page
    End point title
    		 Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
    End point description
    CA-125 Response rate was defined 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. The CA-125-evaluable population included all randomized population whose pretreatment sample was ≥ 2.0 times the upper limit of normal, within 2 weeks prior to randomization, and who had at least 1 post-baseline CA-125 evaluation.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    203
    82
    Units: Percentage of participants
        number (confidence interval 95%)
    51 (44.1 to 58.3)
    27 (17.6 to 37.8)
    No statistical analyses for this end point

    Secondary: PFS, as Assessed by Investigator Per RECIST Version 1.1

    		 Close Top of page
    End point title
    		 PFS, as Assessed by Investigator Per RECIST Version 1.1
    End point 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 lesions, 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. The ITT population included all participants randomized in the study.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    248
    118
    Units: months
        median (confidence interval 95%)
    4.27 (4.11 to 5.06)
    4.24 (2.76 to 5.36)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR), as Assessed by BIRC Per RECIST Version 1.1

    		 Close Top of page
    End point title
    		 Duration of Response (DOR), as Assessed by BIRC Per RECIST Version 1.1
    End point 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 lesions, 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. The ITT population included all participants randomized in the study. Here, the 'number of subjects analysed' signifies participants evaluable for this outcome measure and values of '99999' = not calculable.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Number of subjects analysed
    55
    14
    Units: months
        median (confidence interval 95%)
    5.65 (4.17 to 8.51)
    7.26 (4.14 to 99999)
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Over All Time Measurements (AUClast) of Mirvetuximab Soravtansine, Total M9346A Antibody, DM4, and S-methyl DM4

    		 Close Top of page
    End point title
    		 Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Over All Time Measurements (AUClast) of Mirvetuximab Soravtansine, Total M9346A Antibody, DM4, and S-methyl DM4 [3]
    End point description
    Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. The PK population included all participants who received at least 1 infusion of mirvetuximab soravtansine, had evaluable PK data, and had samples collected with no major deviations related to administration of study drug. Here, the 'number of subjects analysed' signifies participants evaluable for this outcome measure and n = number of participants analyzed in each cycle.
    End point type
    Secondary
    End point timeframe
    Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; single samples were taken on Days 8 and 15 of Cycles 1 and 3
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic assessment was pre-specified for the Mirvetuximab Soravtansine arm only.
    End point values
    		 Mirvetuximab Soravtansine
    Number of subjects analysed
    235
    Units: hours*milligrams/milliliter (hr*mg/mL)
    arithmetic mean (standard deviation)
        Mirvetuximab Soravtansine at Cycle 1 (n = 235)
    20.53 ( 10.31 )
        Mirvetuximab Soravtansine at Cycle 3 (n = 146)
    22.40 ( 7.770 )
        Total M9346A antibody at Cycle 1 (n = 235)
    23.23 ( 9.463 )
        Total M9346A antibody at Cycle 3 (n = 146)
    31.20 ( 11.52 )
        DM4 at Cycle 1 (n = 233)
    348.5 ( 265.7 )
        DM4 at Cycle 3 (n = 142)
    347.4 ( 280.9 )
        S-methyl DM4 at Cycle 1 (n = 234)
    1586 ( 1496 )
        S-methyl DM4 at Cycle 3 (n = 146)
    1512 ( 1278 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibodies (ADA)

    		 Close Top of page
    End point title
    		 Number of Participants With Anti-Drug Antibodies (ADA) [4]
    End point 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. The immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
    End point type
    Secondary
    End point timeframe
    Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1, 2, and 4, and pre-dose on Day 1 of Cycle 6
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity assessment was pre-specified for the Mirvetuximab Soravtansine arm only.
    End point values
    		 Mirvetuximab Soravtansine
    Number of subjects analysed
    230
    Units: Participants
    13
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    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)
    Adverse event reporting additional description
    The safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Mirvetuximab Soravtansine
    Reporting group description
    		 Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by the BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Reporting group title
    Investigator’s Choice (IC) Chemotherapy
    Reporting group description
    		 Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or PLD 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, PLD could have been administered as a 1-hour infusion. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study.

    Serious adverse events
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 243 (27.57%)
    31 / 109 (28.44%)
         number of deaths (all causes)
    96
    50
         number of deaths resulting from adverse events
    5
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour obstruction
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 243 (0.00%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 243 (0.41%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 243 (0.82%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    5 / 243 (2.06%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    7 / 243 (2.88%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    7 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 243 (1.23%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    2 / 243 (0.82%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 243 (0.82%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratopathy
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 243 (1.23%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 243 (0.41%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 243 (1.65%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    10 / 243 (4.12%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    4 / 243 (1.65%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 243 (0.82%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 243 (2.06%)
    4 / 109 (3.67%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 243 (0.82%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 243 (1.23%)
    3 / 109 (2.75%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Systemic infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 243 (0.82%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 243 (0.41%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 243 (1.65%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mirvetuximab Soravtansine Investigator’s Choice (IC) Chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    239 / 243 (98.35%)
    103 / 109 (94.50%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 243 (6.58%)
    4 / 109 (3.67%)
         occurrences all number
    25
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    51 / 243 (20.99%)
    25 / 109 (22.94%)
         occurrences all number
    90
    73
    Fatigue
         subjects affected / exposed
    83 / 243 (34.16%)
    38 / 109 (34.86%)
         occurrences all number
    138
    85
    Influenza like illness
         subjects affected / exposed
    4 / 243 (1.65%)
    6 / 109 (5.50%)
         occurrences all number
    4
    7
    Mucosal inflammation
         subjects affected / exposed
    2 / 243 (0.82%)
    6 / 109 (5.50%)
         occurrences all number
    2
    6
    Oedema peripheral
         subjects affected / exposed
    8 / 243 (3.29%)
    10 / 109 (9.17%)
         occurrences all number
    9
    11
    Pyrexia
         subjects affected / exposed
    25 / 243 (10.29%)
    7 / 109 (6.42%)
         occurrences all number
    29
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    39 / 243 (16.05%)
    15 / 109 (13.76%)
         occurrences all number
    48
    19
    Dyspnoea
         subjects affected / exposed
    36 / 243 (14.81%)
    16 / 109 (14.68%)
         occurrences all number
    49
    24
    Pneumonitis
         subjects affected / exposed
    13 / 243 (5.35%)
    1 / 109 (0.92%)
         occurrences all number
    17
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    14 / 243 (5.76%)
    8 / 109 (7.34%)
         occurrences all number
    20
    9
    Insomnia
         subjects affected / exposed
    23 / 243 (9.47%)
    16 / 109 (14.68%)
         occurrences all number
    24
    18
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    40 / 243 (16.46%)
    6 / 109 (5.50%)
         occurrences all number
    80
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    43 / 243 (17.70%)
    8 / 109 (7.34%)
         occurrences all number
    94
    8
    Blood alkaline phosphatase increased
         subjects affected / exposed
    19 / 243 (7.82%)
    4 / 109 (3.67%)
         occurrences all number
    27
    4
    Weight decreased
         subjects affected / exposed
    17 / 243 (7.00%)
    4 / 109 (3.67%)
         occurrences all number
    24
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    16 / 243 (6.58%)
    3 / 109 (2.75%)
         occurrences all number
    20
    3
    Dysgeusia
         subjects affected / exposed
    30 / 243 (12.35%)
    9 / 109 (8.26%)
         occurrences all number
    33
    11
    Headache
         subjects affected / exposed
    57 / 243 (23.46%)
    14 / 109 (12.84%)
         occurrences all number
    86
    20
    Neurotoxicity
         subjects affected / exposed
    9 / 243 (3.70%)
    6 / 109 (5.50%)
         occurrences all number
    14
    16
    Peripheral neuropathy
         subjects affected / exposed
    86 / 243 (35.39%)
    21 / 109 (19.27%)
         occurrences all number
    151
    34
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    34 / 243 (13.99%)
    32 / 109 (29.36%)
         occurrences all number
    54
    91
    Leukopenia
         subjects affected / exposed
    9 / 243 (3.70%)
    16 / 109 (14.68%)
         occurrences all number
    24
    38
    Neutropenia
         subjects affected / exposed
    16 / 243 (6.58%)
    43 / 109 (39.45%)
         occurrences all number
    36
    119
    Thrombocytopenia
         subjects affected / exposed
    27 / 243 (11.11%)
    17 / 109 (15.60%)
         occurrences all number
    80
    52
    Eye disorders
    Cataract
         subjects affected / exposed
    36 / 243 (14.81%)
    2 / 109 (1.83%)
         occurrences all number
    52
    2
    Dry eye
         subjects affected / exposed
    68 / 243 (27.98%)
    2 / 109 (1.83%)
         occurrences all number
    122
    2
    Eye pain
         subjects affected / exposed
    31 / 243 (12.76%)
    1 / 109 (0.92%)
         occurrences all number
    50
    1
    Keratopathy
         subjects affected / exposed
    83 / 243 (34.16%)
    1 / 109 (0.92%)
         occurrences all number
    185
    1
    Photophobia
         subjects affected / exposed
    34 / 243 (13.99%)
    2 / 109 (1.83%)
         occurrences all number
    48
    2
    Vision blurred
         subjects affected / exposed
    104 / 243 (42.80%)
    6 / 109 (5.50%)
         occurrences all number
    258
    7
    Visual acuity reduced
         subjects affected / exposed
    52 / 243 (21.40%)
    2 / 109 (1.83%)
         occurrences all number
    78
    3
    Vitreous floaters
         subjects affected / exposed
    13 / 243 (5.35%)
    0 / 109 (0.00%)
         occurrences all number
    13
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    26 / 243 (10.70%)
    11 / 109 (10.09%)
         occurrences all number
    33
    13
    Abdominal pain
         subjects affected / exposed
    96 / 243 (39.51%)
    33 / 109 (30.28%)
         occurrences all number
    156
    49
    Ascites
         subjects affected / exposed
    9 / 243 (3.70%)
    6 / 109 (5.50%)
         occurrences all number
    12
    6
    Constipation
         subjects affected / exposed
    64 / 243 (26.34%)
    31 / 109 (28.44%)
         occurrences all number
    89
    38
    Diarrhoea
         subjects affected / exposed
    107 / 243 (44.03%)
    18 / 109 (16.51%)
         occurrences all number
    191
    42
    Dyspepsia
         subjects affected / exposed
    18 / 243 (7.41%)
    5 / 109 (4.59%)
         occurrences all number
    26
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    14 / 243 (5.76%)
    5 / 109 (4.59%)
         occurrences all number
    18
    7
    Nausea
         subjects affected / exposed
    131 / 243 (53.91%)
    46 / 109 (42.20%)
         occurrences all number
    223
    65
    Stomatitis
         subjects affected / exposed
    10 / 243 (4.12%)
    23 / 109 (21.10%)
         occurrences all number
    11
    43
    Vomiting
         subjects affected / exposed
    64 / 243 (26.34%)
    22 / 109 (20.18%)
         occurrences all number
    108
    32
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    7 / 243 (2.88%)
    14 / 109 (12.84%)
         occurrences all number
    7
    16
    Dry skin
         subjects affected / exposed
    4 / 243 (1.65%)
    8 / 109 (7.34%)
         occurrences all number
    4
    8
    Erythema
         subjects affected / exposed
    7 / 243 (2.88%)
    6 / 109 (5.50%)
         occurrences all number
    7
    11
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 243 (0.41%)
    16 / 109 (14.68%)
         occurrences all number
    1
    23
    Pruritus
         subjects affected / exposed
    12 / 243 (4.94%)
    7 / 109 (6.42%)
         occurrences all number
    15
    9
    Rash
         subjects affected / exposed
    10 / 243 (4.12%)
    12 / 109 (11.01%)
         occurrences all number
    10
    22
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    37 / 243 (15.23%)
    7 / 109 (6.42%)
         occurrences all number
    49
    7
    Back pain
         subjects affected / exposed
    23 / 243 (9.47%)
    9 / 109 (8.26%)
         occurrences all number
    29
    10
    Muscle spasms
         subjects affected / exposed
    25 / 243 (10.29%)
    4 / 109 (3.67%)
         occurrences all number
    27
    7
    Myalgia
         subjects affected / exposed
    22 / 243 (9.05%)
    5 / 109 (4.59%)
         occurrences all number
    32
    5
    Pain in extremity
         subjects affected / exposed
    15 / 243 (6.17%)
    7 / 109 (6.42%)
         occurrences all number
    18
    9
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    28 / 243 (11.52%)
    11 / 109 (10.09%)
         occurrences all number
    39
    16
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    60 / 243 (24.69%)
    16 / 109 (14.68%)
         occurrences all number
    86
    22
    Hypoalbuminaemia
         subjects affected / exposed
    14 / 243 (5.76%)
    3 / 109 (2.75%)
         occurrences all number
    18
    10
    Hypokalaemia
         subjects affected / exposed
    18 / 243 (7.41%)
    9 / 109 (8.26%)
         occurrences all number
    25
    15
    Hypomagnesaemia
         subjects affected / exposed
    40 / 243 (16.46%)
    10 / 109 (9.17%)
         occurrences all number
    62
    19
    Hyponatraemia
         subjects affected / exposed
    9 / 243 (3.70%)
    6 / 109 (5.50%)
         occurrences all number
    14
    8

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2015
    The primary reasons for amending the protocol were to revise the secondary objectives for Stage 1, revise Exclusion Criterion 3 to avoid inclusion of patients with pre-existing ocular conditions, update the management of ocular AEs to align with mirvetuximab soravtansine program-level changes, and to improve clarity and consistency among sections.
    23 Sep 2015
    The primary reason for amending the protocol was to revise the table for management of potential infusion-related reactions.
    20 Oct 2015
    The primary reason for amending the protocol was to provide details on the rationale for the selection of dose levels and the dosing schedule for the chemotherapeutic agents in the IC arm of Stage 2, clarification around high-risk biopsies in Inclusion Criterion 2, modification of the CA-125 assessment schedule, and corrections for inconsistencies among sections.
    01 Feb 2016
    The primary reason for amending the protocol was to add an exclusion criterion for patients with known hypersensitivity to any of the standard of care drugs (gemcitabine, PLD, paclitaxel, or topotecan) and revise Inclusion Criterion 13 regarding the use of contraception methods.
    17 Aug 2016
    The primary reason for amending the protocol was to close enrollment to Stage 1 of the study and revise the study from a Phase 2 to a Phase 3 study.
    19 Sep 2016
    The primary reason for amending the protocol was to correct an important typographical error in Inclusion Criterion 2, which affected the definition of the patient population under study. In the previous version of the protocol, platinum-resistant ovarian cancer was defined as disease having progressed within 6 months of completing a minimum of 4 cycles of first-line platinum-containing therapy. The descriptor “first-line” for platinum therapy was a typographical error and has been deleted.
    04 Nov 2016
    The primary reason for amending the protocol was to remove the option for patients on IC chemotherapy to cross over. The study schema was updated to reflect this change.
    08 May 2017
    The primary reason for amending the protocol was to revise Inclusion Criterion 4 to include hormonal therapies and cancer vaccines as prior lines of anti-cancer therapy.
    05 Dec 2019
    The primary reason for amending the protocol was to allow patients who are receiving mirvetuximab soravtansine and experiencing clinical benefit the option to continue to receive mirvetuximab soravtansine after the closure of the study by the Sponsor.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 15:51:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA