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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ while on study drug and up to 30 days after (through study treatment completion, an average of 1 year)
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)
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have to be ready and able to give tissue samples for research purposes.If it is not safe to perform a biopsy, but you have previously collected tumor tissue that is deemed suitable for testing, you can participate in the trial.You have a type of cancer that is not low grade serous or clear cell carcinoma, unless you have metastatic breast cancer with a specific genetic mutation and there are no other effective treatments.You are still experiencing side effects from a previous cancer treatment except for hair loss and mild fatigue.You have had an allergic reaction to drugs that are similar to rucaparib, mirvetuximab soravtansine, or monoclonal antibodies.You have a history of multiple sclerosis or other diseases that damage the protective coating around nerves. You might also have a condition called Eaton-Lambert syndrome which is related to some types of cancer.You can participate in the study if you have recurring endometrial cancer, recurring BRCA mutated ovarian cancer (excluding the first occurrence of platinum sensitive ovarian cancer), or platinum resistant ovarian cancer.You are currently taking part in another experimental treatment.You have a certain type of cancer called low grade serous or clear cell carcinoma, or you have metastatic breast cancer with a specific genetic mutation that cannot be treated with standard methods.You have a neurological condition that may make it difficult to evaluate any new nerve problems that may arise during the study.You are currently breastfeeding.You must have a certain protein called folate receptor-a (FR-alpha) present in your tumor tissue, which can be confirmed by a special test.You have previously had endometrial cancer that has come back. This includes all types of endometrial cancer, even a type called carcinosarcoma.You have a history of seizures that are not under control.You have an ongoing illness that is not being properly managed.You have a current or long-term eye condition affecting the cornea.You have been diagnosed with non-infectious pneumonitis before.The tissue sample for the biopsy must be from a solid tumor, not from fluid buildup in the body.You have cancer that has come back in your ovaries, fallopian tubes or the lining of your abdomen (in females only).If you have ovarian cancer and other treatments have worked for you, you cannot participate in the first part of the study.If the initial sample of your tumor tissue is not sufficient, a previously collected sample can be used instead. However, this must be done before starting treatment with rucaparib or mirvetuximab soravtansine.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mirvetuximab soravtansine, rucaparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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