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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843165
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Sharabi, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: CBI Radiation: CBI plus SBRT Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
Actual Study Start Date : May 3, 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: CBI plus SBRT
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Radiation: CBI plus SBRT
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)

Active Comparator: CBI
Checkpoint blockade immunotherapy (CBI)
Drug: CBI
Approved CBIs (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Responses measured by RECIST at 16 weeks from baseline ]
    Complete response plus partial response


Secondary Outcome Measures :
  1. Safety and toxicity of combined CBI plus SBRT [ 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 ]
    Adverse events assessed from time of first dose to treatment completion (approximately 1 year)

  2. Progression Free Survival [ Time Frame: Assessed at 5 years ]
    The time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first

  3. Overall Survival [ Time Frame: Assessed at 5 years ]
    The time from starting treatment until death due to any cause.

  4. Rate of Stable Disease [ Time Frame: Assessed at 5 years ]
    The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.

  5. Change in anti-tumor immune response [ 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843165


Contacts
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Contact: Ceonne Kim (858) 822-0201 cek008@ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Andrew Sharabi, MD, PhD University of California, San Diego
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Responsible Party: Andrew Sharabi, Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02843165    
Other Study ID Numbers: 151570
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by Andrew Sharabi, University of California, San Diego:
stereotactic body radiation therapy
checkpoint blockade immunotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes