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NCT06682988 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
A Phase 2 study of Primary Peritoneal and Fallopian Tube Cancers, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT06682988: Recruiting Phase 2 study of Primary Peritoneal and Fallopian Tube Cancers, sponsored by AbbVie.
NCT06682988 is a Phase 2 study of Primary Peritoneal and Fallopian Tube Cancers that is actively recruiting participants, run by AbbVie. The registered enrollment target is 110 participants, below the 444-participant average among 3 other Primary Peritoneal trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06682988, a Phase 2 study of Primary Peritoneal and Fallopian Tube Cancers, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Primary Outcome
An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.
Conditions Studied
Interventions
- DRUG Mirvetuximab Soravtansine
Study Locations (20)
Gyeonggido
- National Cancer Center /ID# 272265 - Goyang-si
- CHA Bundang Medical Center /ID# 271590 - Seongnam
- Seoul National University Bundang Hospital /ID# 271594 - Seongnam-si
Kentucky
- St. Elizabeth Medical Center - Edgewood /ID# 272113 - Edgewood
- Baptist Health Lexington /ID# 272211 - Lexington
New South Wales
- Blacktown Hospital /ID# 272182 - Blacktown
- Newcastle Private Hosptial /ID# 272213 - Lambton Heights
Queensland
- Royal Brisbane and Women's Hospital /ID# 272123 - Brisbane
- Icon Cancer Centre Chermside /ID# 272220 - Chermside
Victoria
- Ballarat Base Hospital /ID# 272240 - Ballarat
- Monash Health - Monash Medical Centre /ID# 272234 - Clayton
Florida
- First Physicians Group /ID# 272180 - Sarasota
Massachusetts
- UMass Memorial Medical Center /ID# 272122 - Worcester
Michigan
- Karmanos Cancer Institute - Detroit /ID# 272112 - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-05-28 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT06682988 shows while recruiting
NCT06682988 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 444-participant average among 3 other Primary Peritoneal trials with a reported enrollment target (75% lower).
The record links to 5 conditions, with Primary Peritoneal appearing as the primary indexed condition, and to 1 intervention - of which Mirvetuximab Soravtansine is the first listed.
NCT06682988 names 20 study sites across 14 states, led by Gyeonggido, Kentucky, New South Wales.
Frequently Asked Questions
What is clinical trial NCT06682988 about?
NCT06682988 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine". Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallo...
What is the current status of trial NCT06682988?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2025-05-28. Estimated completion is 2028-03.
What conditions does trial NCT06682988 study?
This clinical trial studies the following conditions: Primary Peritoneal, Fallopian Tube Cancers, Advanced High-Grade Epithelial Ovarian, High Folate Receptor-Alpha Expression, Platinum Resistant.
What interventions are being tested in trial NCT06682988?
The interventions under investigation include: Mirvetuximab Soravtansine (DRUG).
Who is sponsoring clinical trial NCT06682988?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06682988 being conducted?
This trial has 20 study locations across Florida, Kentucky, Massachusetts, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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