Trial · NCT05456685
Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer
NCT05456685, Phase 2, Active not recruiting, AbbVie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer. Trials, record NCT05456685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05456685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer
- NCT number
- NCT05456685
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- High Grade Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab soravtansine, Carboplatin
- First posted
- 2022-07-13
- Last updated
- 2025-10-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 3 years | ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to RECIST v1.1, defined as the proportion of confirmed responders (CR or PR) among participants with FRα expression of ≥ 50% o ORR following carboplatin plus MIRV combination will also be measured, as a sensitivity analysis, by a blinded independent central review (BICR) in the same participant population |
| Secondary | Overall Response Rate (ORR) | Up to 3 years | ORR, defined as the proportion of confirmed responders (CR or PR) following carboplatin plus MIRV combination, as measured by the investigator and assessed according to RECIST v1.1, among patients with FRα expression of ≥ 25% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion. o ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population. |
| Secondary | Duration of Response (DOR) | Up to 3 years | DOR, defined as the time from first response to radiological progressive disease (PD) or death, whichever occurs first, following carboplatin plus MIRV followed by MIRV continuation by the investigator and assessed according to RECIST v1.1 among efficacy evaluable participants: * with FRα expression of ≥ 50% of tumor cells with PS2+ staining and * with FRα expression of ≥ 25% of tumor cells with PS2+ staining * DOR in the above populations will also be measured by BICR |
| Secondary | Progression Free Survival (PFS) | Up to 3 years | PFS as measured by the investigator and by BICR in participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα expression of ≥ 25% of tumor cells with PS2+ staining |
| Secondary | Overall Survival (OS) | Up to 3 years | OS in participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα of ≥ 25% of tumor cells with PS2+ staining |
| Secondary | Cancer Antigen (CA)-125 Response | Up to 3 years | CA-125 response as measured by the investigator, per Gynecologic Cancer Intergroup (GCIG), in the efficacy evaluable participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα expression of ≥ 25% of tumor cells with PS2+ staining |
| Secondary | Number of Participants With treatment Emergent Adverse Events (TEAEs) | Up to 3 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05456685
GET https://conductscience.org/api/trials/v1/NCT05456685/registered