Trial · NCT04209855
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
NCT04209855, Phase 3, Completed, AbbVie; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression. Trials, record NCT04209855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04209855
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
- NCT number
- NCT04209855
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 453 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab Soravtansine, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin
- First posted
- 2019-12-24
- Last updated
- 2025-08-27
- Other registries' IDs
- eudract:2019-003509-80
- Results first posted
- 2024-08-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From randomization until PD or death, whichever occurred first (up to approximately 36 months) | PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. 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 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
| Secondary | Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 36 months | ORR was defined as percentage of participants with a confirmed 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 \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD. |
| Secondary | Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to approximately 45 months | Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method. |
| Secondary | Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) | Baseline and Week 8 or 9 | The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 37 months | An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 34 months | DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. 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 have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Baseline up to approximately 36 months | The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days. |
| Secondary | Time to Second Progression-Free Survival (PFS 2) | Up to approximately 44 months | PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From randomization until PD or death, whichever occurred first (up to approximately 36 months) | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 36 months | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to approximately 45 months | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). | months | MEDIAN |
| SECONDARY | Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) | Baseline and Week 8 or 9 | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 37 months | The Safety Population included all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 34 months | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, Overall number of participants analyzed is the number of evaluable participants for this outcome measure who had CR or PR. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Baseline up to approximately 36 months | The CA-125-Evaluable Population included all randomized participants who received at least 1 dose of MIRV or IC Chemo, whose pretreatment CA-125 was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, and who had at least 1 post-baseline CA-125 evaluation. | percentage of participants | NUMBER |
| SECONDARY | Time to Second Progression-Free Survival (PFS 2) | Up to approximately 44 months | The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). | months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Mirvetuximab Soravtansine | 5.59 | 95% Confidence Interval 4.34 to 5.88 | months | |
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Investigator's Choice (IC) Chemotherapy | 3.98 | 95% Confidence Interval 2.86 to 4.47 | months | |
| Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 41.9 | 95% Confidence Interval 35.4 to 48.6 | percentage of participants | |
| Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | Investigator's Choice (IC) Chemotherapy | 15.9 | 95% Confidence Interval 11.4 to 21.4 | percentage of participants | |
| Overall Survival Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 16.85 | 95% Confidence Interval 14.36 to 19.78 | months | |
| Overall Survival Assessed by the Investigator Using RECIST v1.1 | Investigator's Choice (IC) Chemotherapy | 13.34 | 95% Confidence Interval 11.37 to 15.15 | months | |
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) | Mirvetuximab Soravtansine | 34 | Participants | ||
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) | Investigator's Choice (IC) Chemotherapy | 23 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine | 211 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Investigator's Choice (IC) Chemotherapy | 194 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirvetuximab Soravtansine | 227 | |
| Overall Study | STARTED | Investigator's Choice (IC) Chemotherapy | 226 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Mirvetuximab Soravtansine | 218 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Investigator's Choice (IC) Chemotherapy | 207 | |
| Overall Study | COMPLETED | Mirvetuximab Soravtansine | 0 | |
| Overall Study | COMPLETED | Investigator's Choice (IC) Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Mirvetuximab Soravtansine | 227 | |
| Overall Study | NOT COMPLETED | Investigator's Choice (IC) Chemotherapy | 226 |
Source ClinicalTrials.gov
Adverse events306
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 30 | 227 | 66 |
| other | ANAEMIA | Blood and lymphatic system disorders | Investigator's Choice (IC) Chemotherapy | 79 | 226 | 212 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 3 | 227 | 3 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Investigator's Choice (IC) Chemotherapy | 12 | 226 | 34 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 27 | 227 | 49 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Investigator's Choice (IC) Chemotherapy | 62 | 226 | 185 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 16 | 227 | 20 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Investigator's Choice (IC) Chemotherapy | 35 | 226 | 81 |
| other | CATARACT | Eye disorders | Mirvetuximab Soravtansine | 67 | 227 | 132 |
| other | CATARACT | Eye disorders | Investigator's Choice (IC) Chemotherapy | 28 | 226 | 31 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirvetuximab Soravtansine | 162 | 227 |
| Total, all-cause mortality | Investigator's Choice (IC) Chemotherapy | 177 | 226 |
| Total, other adverse events | Mirvetuximab Soravtansine | 212 | 227 |
| Total, other adverse events | Investigator's Choice (IC) Chemotherapy | 196 | 226 |
| Total, serious adverse events | Mirvetuximab Soravtansine | 62 | 227 |
| Total, serious adverse events | Investigator's Choice (IC) Chemotherapy | 73 | 226 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) | Trial comparisons |
| Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: deaths from any cause | Trial comparisons |
| Mirvetuximab Soravtansine vs Investigator's Choice (IC) Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04209855
GET https://conductscience.org/api/trials/v1/NCT04209855/events?page=2