Metastatic CancerPhase 2NCT02843165
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
A Phase 2 study testing Checkpoint blockade immunotherapy and Checkpoint blockade immunotherapy plus SBRT in people with Metastatic Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Checkpoint blockade immunotherapy and Checkpoint blockade immunotherapy plus SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2016to 15 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- Checkpoint blockade immunotherapy, Checkpoint blockade immunotherapy plus SBRT
- Keywords
- stereotactic body radiation therapy, checkpoint blockade immunotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checkpoint blockade immunotherapyDrug
Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
Checkpoint blockade immunotherapy plus SBRTRadiation
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)
| Study group | Role | What they receive |
|---|---|---|
| Checkpoint blockade immunotherapy plus SBRT | Experimental | Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT) Receives: Radiation: Checkpoint blockade immunotherapy plus SBRT |
| Checkpoint blockade immunotherapy | Active comparator | Checkpoint blockade immunotherapy (CBI) alone Receives: Drug: Checkpoint blockade immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Responses measured by RECIST at 16 weeks from baseline
Secondary outcomes (4)
Number of Participants With Adverse Events
Adverse events assessed from time of first dose to treatment completion (approximately 1 year)
Measured: up to 5 years
Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Assessed at 5 years
Overall Survival
The time from starting treatment until death due to any cause.
Measured: Assessed at 5 years
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.
Measured: Assessed at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start2 Sep 2016
- Primary completion16 Aug 2021
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Sharabi, University of California, San Diego
- Investigators
- Andrew Sharabi, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843165
- Sponsor's protocol ID
- 151570
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2016
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
- ClinicalTrials.gov ID
- NCT02843165
- Acronym / sponsor ID
- 151570
- Conditions
- Metastatic Cancer
- Keywords
- stereotactic body radiation therapy, checkpoint blockade immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Posted 28 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Checkpoint blockade immunotherapy plus SBRT | Experimental | Radiation: Checkpoint blockade immunotherapy plus SBRTCheckpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT) |
| Checkpoint blockade immunotherapy | Active comparator | Drug: Checkpoint blockade immunotherapyCheckpoint blockade immunotherapy (CBI) alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checkpoint blockade immunotherapyApproved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies) | Drug | Checkpoint blockade immunotherapy |
| Checkpoint blockade immunotherapy plus SBRTSBRT 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) | Radiation | Checkpoint blockade immunotherapy plus SBRT |
Primary outcome
Objective Response Rate
Time frame: Responses measured by RECIST at 16 weeks from baseline
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.
4 secondary outcomes
Number of Participants With Adverse Events
Time frame: up to 5 years
Progression Free Survival
Time frame: Assessed at 5 years
Overall Survival
Time frame: Assessed at 5 years
Rate of Stable Disease
Time frame: Assessed at 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sharabi, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Checkpoint blockade immunotherapy and Checkpoint blockade immunotherapy plus SBRT in people with Metastatic Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Responses measured by RECIST at 16 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.