Trial · NCT04296890
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
NCT04296890, Phase 3, Completed, ImmunoGen, Inc.; results first posted 2024-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression. Trials, record NCT04296890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04296890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
- NCT number
- NCT04296890
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 106 participants, actual
- Lead sponsor
- ImmunoGen, Inc.
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab Soravtansine
- First posted
- 2020-03-05
- Last updated
- 2024-08-07
- Other registries' IDs
- eudract:2020-000179-19
- Results first posted
- 2024-08-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 15 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 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD. |
| Secondary | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 15 months | DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was 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 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 estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to approximately 15 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 | Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 15 months | PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
| Secondary | Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to approximately 27 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 With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 27 months | An adverse event (AE) was defined as 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 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 all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 15 months | The investigator (INV) Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 15 months | All participants that showed a CR or PR according to RECIST 1.1 were analyzed. | months | MEDIAN |
| SECONDARY | Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to approximately 15 months | The CA-125-Evaluable population was defined as all participants who received at least 1 dose of study drug and whose pretreatment sample was ≥2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 postbaseline CA-125 evaluation. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 15 months | INV Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1. | months | MEDIAN |
| SECONDARY | Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to approximately 27 months | INV Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 27 months | The Safety population was defined as participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Mirvetuximab Soravtansine | 32.4 | 95% Confidence Interval 23.6 to 42.2 | percentage of participants | |
| Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 6.93 | 95% Confidence Interval 5.55 to 9.66 | months | |
| Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Mirvetuximab Soravtansine | 46.5 | 95% Confidence Interval 35.7 to 57.6 | percentage of participants | |
| Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 4.27 | 95% Confidence Interval 3.71 to 5.22 | months | |
| Overall Survival Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 15.0 | 95% Confidence Interval 11.5 to 18.7 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine | 105 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirvetuximab Soravtansine | 106 | |
| Overall Study | INV Efficacy Evaluable Population | Mirvetuximab Soravtansine | 105 | |
| Overall Study | COMPLETED | Mirvetuximab Soravtansine | 38 | |
| Overall Study | NOT COMPLETED | Mirvetuximab Soravtansine | 68 |
Source ClinicalTrials.gov
Adverse events80
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 | Alanine aminotransferase increased | Investigations | Mirvetuximab Soravtansine | 12 | 106 | |
| other | Aspartate aminotransferase increased | Investigations | Mirvetuximab Soravtansine | 16 | 106 | |
| other | Blood alkaline phosphatase increased | Investigations | Mirvetuximab Soravtansine | 12 | 106 | |
| other | Gamma-glutamyltransferase increased | Investigations | Mirvetuximab Soravtansine | 13 | 106 | |
| other | Weight decreased | Investigations | Mirvetuximab Soravtansine | 6 | 106 | |
| other | Dysgeusia | Nervous system disorders | Mirvetuximab Soravtansine | 8 | 106 | |
| other | Headache | Nervous system disorders | Mirvetuximab Soravtansine | 10 | 106 | |
| other | Neuropathy peripheral | Nervous system disorders | Mirvetuximab Soravtansine | 19 | 106 | |
| other | Anaemia | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 14 | 106 | |
| other | Neutropenia | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 16 | 106 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirvetuximab Soravtansine | 62 | 106 |
| Total, other adverse events | Mirvetuximab Soravtansine | 102 | 106 |
| Total, serious adverse events | Mirvetuximab Soravtansine | 36 | 106 |
Source ClinicalTrials.gov
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04296890
GET https://conductscience.org/api/trials/v1/NCT04296890/events?page=2