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Monoclonal Antibodies

Carboplatin + Mirvetuximab for Ovarian Cancer

Phase 2

Recruiting

Led By Rebecca Arend, M.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in >75% of cells

Patients must have a performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 2 years

Awards & highlights

Study Summary

This trial is testing a new combo of drugs to treat ovarian cancer that has come back or hasn't respond to other treatments.

Who is the study for?

This trial is for women with advanced-stage ovarian, fallopian tube, or primary peritoneal cancer who haven't had previous systemic anti-cancer therapy. They must have high-grade serous epithelial ovarian cancer that's positive for FRα expression and be fit enough to undergo chemotherapy and surgery. Women of childbearing potential must use effective contraception and not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests a combination of Carboplatin with Mirvetuximab Soravtansine (MIRV) in patients whose tumors over-express the FRα receptor. Participants will receive this treatment every three weeks before surgery, followed by additional cycles after surgery. The option to add Bevacizumab or maintenance therapy later on is at the physician's discretion.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to monoclonal antibodies like MIRV, liver or kidney function issues from Carboplatin, as well as general side effects from chemotherapy such as fatigue, nausea, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is mostly positive for a specific protein marker.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My ovarian cancer is confirmed as high grade serous type.

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My cancer is at stage III or IV and I can start treatment before surgery.

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I am willing to provide a sample of my tumor for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Radiographic tumor assessment per RECIST v1.1 criteria

progression free survival (PFS)

Secondary outcome measures

Therapeutic procedure

CA-125 Antigen

Trial Design

1Treatment groups

Experimental Treatment

Group I: neoadjuvant chemotherapy regimenExperimental Treatment1 Intervention

IV Carboplatin AUC 5 (Q21 days) 7 cycles (first cycle is Carbo alone, dosing for C1D1 will be provider's choice) IV Mirvetuximab 6 mg/kg (adjusted ideal body weight) day 1 (Q21 days) 6 cycles (starting with cycle #2)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,284 Total Patients Enrolled

14 Trials studying Ovarian Cancer

1,368 Patients Enrolled for Ovarian Cancer

Rebecca Arend, M.D.5.02 ReviewsPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

5Patient Review

Dr. Arend is a very kind and considerate doctor. She and her whole staff made me feel safe and confident in their abilities. I was most impressed by her compassion, dedication, and knowledge.

Media Library

Mirvetuximab Soravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606914 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any previous investigations that have utilized mirvetuximab soravtansine (MIRV; IMGN853)?

"Presently, there are 8 medical studies that involve mirvetuximab soravtansine (MIRV; IMGN853), with one of them in the final stage. Although multiple trials for this drug take place in Columbus, Ohio alone, a total of 318 clinical centres offer research on MIRV globally."

Answered by AI

What is the upper limit of individuals participating in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the recruitment process is currently live for this trial which was initially posted on May 27th 2021 and revised lastly on June 30th 2022. 70 participants are being sought at one particular site of examination."

Answered by AI

To what degree is mirvetuximab soravtansine (MIRV; IMGN853) deemed secure for human consumption?

"MIRV; IMGN853 has been assigned a safety rating of 2 due to the Phase 2 nature of this trial. While there is evidence that suggests it is safe, no data exists yet on its efficacy."

Answered by AI

Are there any openings left in this trial for participants?

"Affirmative. Per information on clinicaltrials.gov, this medical trial is currently recruiting patients who fit its enrollment criteria; the study was first posted on May 27th 2021 and latest updates were added on June 30th 2022. 70 participants are needed to be sourced from one site in particular."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Rebecca Arend 2021. "Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04606914.

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