Overview

Stereotactic Ablative Radiotherapy (SABR) in Combination With Durvalumab and Tremelimumab in Patients With Cervical, Vaginal, or Vulvar Cancer

Status:
Recruiting

Trial end date:
2020-10-01

Target enrollment:

Participant gender:

Summary

The goal of this clinical research study is to learn if it is safe to give a special type of radiation called stereotactic ablative radiotherapy (SABR) in combination with durvalumab and tremelimumab to patients with advanced forms of cervical, vaginal, or vulvar cancer that is recurrent (has returned after treatment) and/or metastatic (has spread). Researchers also want to learn if this combination can help to control the disease. SABR is a type of radiation commonly used to treat various types of cancer with larger doses of radiation focused precisely at the tumor. This is an investigational study. Durvalumab is FDA approved for the treatment of urothelial cancer. Tremelimumab is not FDA approved or commercially available. The use of these drugs in combination with SABR is investigational. SABR is delivered using FDA-approved and commercially available methods. The study doctor can describe how the study drugs and radiation are designed to work. Up to 18 patients will enroll in this multi-center study. Up to 9 will take part at MD Anderson.

Phase:

Phase 1

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

AstraZeneca

Treatments:

Antibodies, Monoclonal
Tremelimumab