Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Andrew Sharabi, MD, PhD (ucsd)
Headshot of Andrew Sharabi
Andrew Sharabi

Description

Summary

The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.

Official Title

Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease

Details

Patients who will receive anti-PD-1/PD-L1 immunotherapy with at least 1 site of measurable metastatic disease which will not be irradiated will be candidates for the study. Patients will be randomized (1:1) to CBI combined with SBRT or CBI alone. SBRT at 9.5Gy x3 fractions will be delivered within 1-21 days of the start of first cycle of CBI. The first six patients will be treated and observed for toxicity in the safety run-in phase for 30 days after radiation before continuing with further accrual. Radiation dose reduction is allowed if necessary to meet tissue constraints (6Gyx3 Minimum Dose). Response rates will be determined from the non-irradiated lesion/lesions. Blood draws will be obtained to analyze anti-tumor immune responses.

Keywords

Metastatic Cancer, stereotactic body radiation therapy, checkpoint blockade immunotherapy, Neoplasm Metastasis, Immunomodulating Agents, Immunologic Factors, Checkpoint blockade immunotherapy plus SBRT

Eligibility

Location

  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at University of California Health

  • Andrew Sharabi, MD, PhD (ucsd)
    Dr. Andrew Sharabi is a physician scientist and board-certified radiation oncologist at UC San Diego Moores Cancer Center. He sees patients at the La Jolla Moores Cancer Center and his specialties include Prostate (Genitourinary) and Head and Neck Cancers.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02843165
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 146 study participants
Last Updated