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RECRUITING 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

NCT06682988 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 110 participants
Start Date 2025-05-28
Est. Completion 2028-03
Phase Phase 2

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06682988

The ClinicalTrials.gov registry entry for NCT06682988 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06682988 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Gyeonggido, Kentucky, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06682988?

The interventions under investigation include: Mirvetuximab Soravtansine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06682988?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial