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← Malignant Fallopian Tube Neoplasm

NCT02631876 · STUDY IN CONTEXT

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 P

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

ITT population included all participants randomized in the study.

→

primary · POSTED

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.

ITT population included all participants randomized in the study. Here, overall number of participants analyzed signifies participants with high folate receptor alpha level.

→

secondary · POSTED

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.

ITT population included all participants randomized in the study.

→

secondary · POSTED

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.

ITT population included all participants randomized in the study.

→

secondary · POSTED

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.

ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.

→

secondary · POSTED

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.

Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · 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

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT02631876
qol key
qol-0004
source section id
NCT02631876-om-0004
source outcome index
4
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale 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
measure definition
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
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT02631876
trial label
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 P
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0000
    source section id
    NCT02631876-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study
    endpoint definition
    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 origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0001
    source section id
    NCT02631876-om-0001
    source outcome index
    1
    endpoint
    PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)
    endpoint definition
    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 origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized in the study. Here, overall number of participants analyzed signifies participants with high folate receptor alpha level.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0002
    source section id
    NCT02631876-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1
    endpoint definition
    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 origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0003
    source section id
    NCT02631876-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    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 origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0004
    source section id
    NCT02631876-om-0004
    source outcome index
    4
    endpoint
    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
    endpoint definition
    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 origin
    Baseline, Week 8/9
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0005
    source section id
    NCT02631876-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    endpoint definition
    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 origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    248
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    118
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    248
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    118
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    248
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    118
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    142
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Mirvetuximab Soravtansine
    regimen
    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 BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    analyzed count
    243
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Investigator's Choice (IC) Chemotherapy
    regimen
    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 pegylated liposomal doxorubicin 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 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. (Maximum exposure: 62.9 weeks)
    analyzed count
    109
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02631876-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    harm key
    EG000
    source section id
    NCT02631876-ae
    event group key
    EG000
    event group label
    Mirvetuximab Soravtansine
    serious affected
    67
    serious at risk
    243
    other affected
    242
    other at risk
    243
    frequency threshold
    0
    collection period
    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)
    event definition
    Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    harm key
    EG001
    source section id
    NCT02631876-ae
    event group key
    EG001
    event group label
    Investigator's Choice (IC) Chemotherapy
    serious affected
    31
    serious at risk
    109
    other affected
    106
    other at risk
    109
    frequency threshold
    0
    collection period
    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)
    event definition
    Safety population included all enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-fallopian-tube-neoplasm
    nct id
    NCT02631876
    qol key
    qol-0004
    source section id
    NCT02631876-om-0004
    source outcome index
    4
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale 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
    measure definition
    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
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population included all participants randomized in the study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice