Back to resultsCheckpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
Primary Purpose
Metastatic Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Checkpoint blockade immunotherapy
Checkpoint blockade immunotherapy plus SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring stereotactic body radiation therapy, checkpoint blockade immunotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCSD Moores Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Checkpoint blockade immunotherapy plus SBRT
Checkpoint blockade immunotherapy
Arm Description
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy (CBI) alone
Outcomes
Primary Outcome Measures
Objective Response Rate
Complete response plus partial response
Secondary Outcome Measures
Safety and toxicity of combined CBI plus SBRT
Adverse events assessed from time of first dose to treatment completion (approximately 1 year)
Progression Free Survival
The time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first
Overall Survival
The time from starting treatment until death due to any cause.
Rate of Stable Disease
The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.
Change in anti-tumor immune response
Lesion and blood assays performed in the lab.
Full Information
NCT ID
NCT02843165
First Posted
July 14, 2016
Last Updated
June 3, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02843165
Brief Title
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
Official Title
Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
stereotactic body radiation therapy, checkpoint blockade immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Checkpoint blockade immunotherapy plus SBRT
Arm Type
Experimental
Arm Description
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Arm Title
Checkpoint blockade immunotherapy
Arm Type
Active Comparator
Arm Description
Checkpoint blockade immunotherapy (CBI) alone
Intervention Type
Drug
Intervention Name(s)
Checkpoint blockade immunotherapy
Intervention Description
Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
Intervention Type
Radiation
Intervention Name(s)
Checkpoint blockade immunotherapy plus SBRT
Intervention Description
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)
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Complete response plus partial response
Time Frame
Responses measured by RECIST at 16 weeks from baseline
Secondary Outcome Measure Information:
Title
Safety and toxicity of combined CBI plus SBRT
Description
Adverse events assessed from time of first dose to treatment completion (approximately 1 year)
Time Frame
Evaluated at each treatment cycle (each cycle is 2 or 3 weeks), then at 8 weeks, 16 weeks, 6 months, 12 months, 18 months, and 24 months, then every 6 months up to 2 years
Title
Progression Free Survival
Description
The time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first
Time Frame
Assessed at 5 years
Title
Overall Survival
Description
The time from starting treatment until death due to any cause.
Time Frame
Assessed at 5 years
Title
Rate of Stable Disease
Description
The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.
Time Frame
Assessed at 5 years
Title
Change in anti-tumor immune response
Description
Lesion and blood assays performed in the lab.
Time Frame
At week 3 or 4 after starting treatment (prior to Cycle 2 of CBI) and at 2 months. Each cycle is 2 or 3 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sharabi, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
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