Clovis CO-3810-101 LIO-1 (gynecological cancers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the study drugs (lucitanib and nivolumab) in advanced or metastatic gynecological cancers.

Lucitanib is a drug that is designed to block growth factors that help tumor cells grow. Nivolumab is a drug that helps block cancer cell’s ability to hide and activate your immune system to attack cancer cells.

What is the Condition Being Studied?

Advanced or recurrent gynecological cancers

Who Can Participate in the Study?

Adult women with advanced or metastatic gynecological cancers (ovarian, endometrial, and cervical)

Age Group
Adults

What is Involved?

If you agree to be in this study you will :
-Get a 28-day supply of lucitanib, (Pill you take once a day)
-Get an IV infusion of nivolumab every 28 days
-Have physicals
-Have blood taken
-May be asked for additional biopsy samples of your tumor

*You will continue to get the study drug until your disease no longer responds to the study drugs, side effects prevent further continuation of the study drugs, you decide to no longer participate, or the study closes.

*Long-term follow up will be made every 3 months until end (up to 3 years).

Study Details

Full Title
A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With an Advanced, Metastatic Solid Tumor
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00104162
NCT: NCT04042116
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698