A Phase IB/II Study of Lucitanib and Nivolumab Immunotherapy in Women with Advanced Gynecologic Cancers

Share
Print

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

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug lucitanib with the immunotherapy drug nivolumab in patients with gynecologic cancers that have returned or spread after previous treatment. Lucitanib may stop tumors from growing by inhibiting proteins that drive the development of new blood vessels that tumors need to grow and spread.

Nivolumab works by taking the brakes off the immune response, enabling immune cells to find and destroy cancer cells. Lucitanib is taken orally (by mouth) and nivolumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced or metastatic endometrial, ovarian, or cervical cancer that has returned or spread after previous treatment.
  • At least 2 weeks must pass between the completion of prior therapies and receipt of the study drugs.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Protocol

20-325

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators