Trial · NCT05041257
Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers
NCT05041257, Phase 2, Completed, AbbVie; results first posted 2026-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers. Trials, record NCT05041257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05041257
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers
- NCT number
- NCT05041257
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab soravtansine
- First posted
- 2021-09-13
- Last updated
- 2026-01-09
- Other registries' IDs
- eudract:2021-003592-34
- Results first posted
- 2026-01-09
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) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1]) | Up to 3 years | 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) Assessed by the Investigator Using RECIST v1.1 | Up to 3 years | 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 3 years | 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 does not necessarily had 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. |
| Secondary | Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to 3 years | 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 3 years | 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 3 years | 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. |
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) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1]) | Up to 3 years | Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Assessed by the Investigator Using RECIST v1.1 | Up to 3 years | Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator. 'Overall number of participants analyzed' = participants with objective response. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 3 years | Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to 3 years | CA-125 Response-Evaluable Population included all participants who received at least 1 dose of mirvetuximab soravtansine, 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 post-baseline CA-125 evaluation. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Up to 3 years | Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator. | months | MEDIAN |
| SECONDARY | Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to 3 years | Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator. | months | MEDIAN |
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) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1]) | Mirvetuximab Soravtansine | 51.9 | 95% Confidence Interval 40.4 to 63.3 | percentage of participants | |
| Duration of Response (DOR) Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 8.25 | 95% Confidence Interval 5.55 to 10.78 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine | 78 | Participants | ||
| Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Mirvetuximab Soravtansine | 74.5 | 95% Confidence Interval 59.7 to 86.1 | percentage of participants | |
| Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 6.93 | 95% Confidence Interval 5.85 to 9.59 | months | |
| Overall Survival Assessed by the Investigator Using RECIST v1.1 | Mirvetuximab Soravtansine | 27.17 | 95% Confidence Interval 23.79 to NA | months |
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 | 79 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Mirvetuximab Soravtansine | 79 | |
| Overall Study | COMPLETED | Mirvetuximab Soravtansine | 0 | |
| Overall Study | NOT COMPLETED | Mirvetuximab Soravtansine | 79 |
Source ClinicalTrials.gov
Adverse events73
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 | 7 | 79 | 11 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 11 | 79 | 34 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Mirvetuximab Soravtansine | 5 | 79 | 9 |
| other | CATARACT | Eye disorders | Mirvetuximab Soravtansine | 27 | 79 | 41 |
| other | CORNEAL EPITHELIAL MICROCYSTS | Eye disorders | Mirvetuximab Soravtansine | 5 | 79 | 11 |
| other | DRY EYE | Eye disorders | Mirvetuximab Soravtansine | 32 | 79 | 49 |
| other | EYE PAIN | Eye disorders | Mirvetuximab Soravtansine | 5 | 79 | 9 |
| other | KERATITIS | Eye disorders | Mirvetuximab Soravtansine | 6 | 79 | 12 |
| other | KERATOPATHY | Eye disorders | Mirvetuximab Soravtansine | 26 | 79 | 57 |
| other | PHOTOPHOBIA | Eye disorders | Mirvetuximab Soravtansine | 13 | 79 | 19 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirvetuximab Soravtansine | 37 | 79 |
| Total, other adverse events | Mirvetuximab Soravtansine | 77 | 79 |
| Total, serious adverse events | Mirvetuximab Soravtansine | 17 | 79 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39617145 | DERIVED |
Source PubMed
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/NCT05041257
GET https://conductscience.org/api/trials/v1/NCT05041257/events?page=2