A Phase 2 Research Study for Patients with Platinum-Resistant Ovarian Cancer

IRB/UVA Tracking #
21535
Principal Investigator
Linda R Duska
Contact
Anne Gabel
Contact Email
Contact Phone
434.982.6657
Official Trial Title
Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen
Study Description

The UVA Cancer Center has a clinical trial for women ages 18 and over who have advanced ovarian cancer or ovarian cancer that has spread to other areas of their body.

The purpose of this Phase 2 study is to see if the antibody drug conjugate drug, tisotumab vedotin, treats ovarian cancer (ie. the amount of time it takes patients to respond to it and how long the response lasts) as well as to try to determine the safety/tolerability of this study drug and its side effects.

The trial will last up to 3 years after the final patient is enrolled; overall study drug treatment will continue for as long are your study doctor thinks the medicine is helping you or another reason for discontinuation has been presented. Once you’ve reached your last dose, you will have an end of dosing visit about one month after. You will then have a follow-up call approximately every 12 weeks. You will also get scanned/blood drawn approximately every 12 weeks for 6 months from the End of Treatment visit, then every 6 months until study completion or treatment discontinuation (whichever is longer).

Research-specific tests (eye pre-medications, procedures done only for the study) and the cost and administration of study drug (tisotumab vedotin) will be provided at no cost to you. The costs of standard tests and procedures will be paid by your insurer in the same way as if you were not part of this study. You may be responsible for any extra costs your insurance company does not pay.

Additional information can be found here: NCT03657043

Compensation

No compensation, but you will be reimbursed for travel expenses as such per visit: up to $160 per night for a hotel room, up to $80 for incidental expenses (including parking, taxi/shuttle, and mileage) and $28 for patient meals.