Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting at 3 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Endometrioid, Clear cell, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for individuals with advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that are resistant to platinum-based treatments. Participants must have a certain level of physical fitness (ECOG PS of 0 or 1), have had specific prior treatments and disease progression, and their tumors must express high levels of folate receptor alpha.

Inclusion Criteria

I am eligible for both groups in the study.

It has been 6 months since my last platinum-based treatment.

My cancer has worsened after my last treatment, as shown by scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mirvetuximab Soravtansine on different schedules depending on the cohort: either on day 1 every 21 days or on days 1 and 15 every 28 days

Up to 24 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mirvetuximab Soravtansine

Trial Overview The study tests Mirvetuximab Soravtansine (MIRV), an experimental drug targeting cancer cells with a protein called folate receptor alpha. There are two groups receiving MIRV on different schedules in the Randomized Phase 2 Cohort and another group for those with abnormal liver function to find the right starting dose.

How Is the Trial Designed?

Group I: Randomized Phase 2 Cohort: Arm B Experimental Treatment 1 Intervention

Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .

Group II: Randomized Phase 2 Cohort: Arm A Experimental Treatment 1 Intervention

Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.

Group III: Hepatic Impairment Cohort : Mirvetuximab Soravtansine Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois