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Antibody-Drug Conjugate

Mirvetuximab + Rucaparib for Ovarian Cancer

Phase 1
Waitlist Available
Led By Floor Backes, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while on study drug and up to 30 days after (through study treatment completion, an average of 1 year)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the combination of two drugs to treat cancer that has returned. The drugs are an antibody linked to a toxic substance, and a drug that may stop the growth of tumor cells.

Who is the study for?
This trial is for people with certain types of recurrent cancers: endometrial, ovarian, fallopian tube or primary peritoneal cancer. Participants must have tumors that are positive for folate receptor-alpha and should not have low-grade serous or clear cell carcinoma unless they carry a BRCA mutation. They need to be in good physical condition (ECOG ? 1), have adequate organ function, and women must agree to use contraception.
What is being tested?
The trial is testing the combination of mirvetuximab soravtansine (an antibody-drug conjugate) and rucaparib camsylate (a PARP inhibitor) on participants with recurrent cancers mentioned above. It aims to determine the safest doses and observe how well these drugs work together against these cancers.
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells, fatigue, digestive issues like nausea or constipation, blood-related problems such as anemia or clotting disorders, liver enzyme changes indicating potential liver damage, and possible heart rhythm abnormalities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on study drug and up to 30 days after (through study treatment completion, an average of 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and while on study drug and up to 30 days after (through study treatment completion, an average of 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recommended phase II dose (RPTD) of mirvetuximab soravtansine and rucaparib camsylate in combination
Secondary study objectives
Incidence of adverse effects graded according to CTCAE v. 4.0
Objective anti-tumor activity (complete and partial response) of mirvetuximab soravtansine and rucaparib in combination
Progression-free survival
Other study objectives
Pharmacokinetics of mirvetuximab soravtansine and rucaparib in combination Cmax trough concentrations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (mirvetuximab soravtansine, rucaparib)Experimental Treatment4 Interventions
Participants receive mirvetuximab soravtansine IV on day 1 and rucaparib PO BID on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirvetuximab Soravtansine
2017
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
339 Previous Clinical Trials
292,145 Total Patients Enrolled
ImmunoGen, Inc.Industry Sponsor
32 Previous Clinical Trials
3,800 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,139 Total Patients Enrolled

Media Library

Mirvetuximab Soravtansine (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03552471 — Phase 1
Fallopian Tube Cancer Research Study Groups: Treatment (mirvetuximab soravtansine, rucaparib)
Fallopian Tube Cancer Clinical Trial 2023: Mirvetuximab Soravtansine Highlights & Side Effects. Trial Name: NCT03552471 — Phase 1
Mirvetuximab Soravtansine (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03552471 — Phase 1
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