A Phase IB/II Study of Tisotumab Vedotin Combined with Other Drugs in Patients with Recurrent or Metastatic Cervical Cancer

Full Title

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax® TF ADC) in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

Purpose

The purpose of this study is to find the safest dose of tisotumab vedotin that can be given with bevacizumab, pembrolizumab, or carboplatin to women with recurrent or metastatic cervical cancer. Tisotumab vedotin is a chemotherapy drug attached to an antibody (“antibody-drug conjugate”). The antibody part of tisotumab vedotin targets a protein on cancer cells and delivers a drug that kills the cancer cells. Researchers think the combination of tisotumab vedotin with bevacizumab, pembrolizumab, or carboplatin may be an effective treatment for women with cervical cancer.

Bevacizumab works by inhibiting the blood vessels that tumors need to grow and spread. Pembrolizumab is an immunotherapy drug that boosts the ability of the immune system to find and kill cancer cells. Carboplatin is a standard chemotherapy drug. Patients in this study will receive one of these drugs in combination with tisotumab vedotin. All of the medications are 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 recurrent or metastatic cervical cancer that continues to grow despite treatment.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Roisin O’Cearbhaill at 646-888-4227.

Protocol

19-177

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators