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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
AbbVie
Study ID
NCT06682988
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced High-Grade Epithelial Ovarian Cancer
  • Fallopian Tube Cancers
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab Soravtansine — DRUG
    intravenous (IV) infusion

Study Details

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.

Key Dates

Start date
May 28, 2025
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized Phase 2 Cohort: Arm A
    Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.
  • Experimental: Randomized Phase 2 Cohort: Arm B
    Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .
  • Experimental: Hepatic Impairment Cohort : Mirvetuximab Soravtansine
    Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.

Primary Outcome Measure

Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) [ Time Frame: Up to Approximately 24 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
First Physicians Group /ID# 272180SarasotaFlorida34239-
St. Elizabeth Medical Center - Edgewood /ID# 272113EdgewoodKentucky41017-
Baptist Health Lexington /ID# 272211LexingtonKentucky40503-
UMass Memorial Medical Center - Belmont Street /ID# 272122WorcesterMassachusetts01605-
Karmanos Cancer Institute - Detroit /ID# 272112DetroitMichigan48201-
Allegheny Health Network West Penn Hospital /ID# 272267PittsburghPennsylvania15244-
Memorial Hermann Texas Medical Center /ID# 272227HoustonTexas77030-

Find similar trials in Sarasota, FL

By research site
First Physicians Group· Sarasota, FLSt. Elizabeth Medical Center - Edgewood· Edgewood, KYBaptist Health Lexington· Lexington, KYUMass Memorial Medical Center - Belmont Street· Worcester, MAKarmanos Cancer Institute - Detroit· Detroit, MIAllegheny Health Network West Penn Hospital· Pittsburgh, PA

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