for people ages 18 years and up (full criteria)
at La Jolla, California
study started
completion around
Principal Investigator
by Andrew Sharabi, MD, PhD
Headshot of Andrew Sharabi
Andrew Sharabi



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


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.


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


You can join if…

Open to people ages 18 years and up

  • Patient has one lesion that is treatable with SBRT.
  • Patient has at least 1 site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on computed tomography (CT) or Magnetic resonance imaging (MRI) which will not be irradiated.
  • Histological confirmation of malignancy (primary or metastatic tumor).
  • Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Patient's screening laboratory values must meet protocol limits.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document.

You CAN'T join if...

  • Patient has had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patient receiving any investigational or experimental agents other than immunotherapy.
  • Patient who has had any prior radiotherapy to the treatment site(s).
  • Patient is a pregnant woman (pregnant women are excluded from this study because radiation treatment has known potential for teratogenic or abortifacient effects).
  • Patient refuses to sign informed consent.


  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Andrew Sharabi, MD, PhD
    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.


in progress, not accepting new patients
Start Date
Completion Date
University of California, San Diego
Phase 2 research study
Study Type
Expecting 146 study participants
Last Updated