Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease

NCT02843165 | Completed Phase 2 Results DMC

• 1 other identifier: 151570
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Cancer

Keywords

stereotactic body radiation therapy; checkpoint blockade immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Responses measured by RECIST at 16 weeks from baseline

Secondary Outcomes (4)

• Number of Participants With Adverse Events

  up to 5 years

• Progression Free Survival

  Assessed at 5 years

• Overall Survival

  Assessed at 5 years

• Rate of Stable Disease

  Assessed at 5 years

Study Arms (2)

Checkpoint blockade immunotherapy plus SBRT

EXPERIMENTAL

Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)

Radiation: Checkpoint blockade immunotherapy plus SBRT

Checkpoint blockade immunotherapy

ACTIVE COMPARATOR

Checkpoint blockade immunotherapy (CBI) alone

Drug: Checkpoint blockade immunotherapy

Interventions

Checkpoint blockade immunotherapy DRUG

Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)

Checkpoint blockade immunotherapy

Checkpoint blockade immunotherapy plus SBRT RADIATION

SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)

Checkpoint blockade immunotherapy plus SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Andrew Sharabi
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Andrew Sharabi, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 25, 2016
• Study Start: September 2, 2016
• Primary Completion: August 16, 2021
• Study Completion: August 15, 2024
• Last Updated: September 30, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-09

Locations

US (1)