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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

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE May 3, 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
Objective Response Rate [ Time Frame: Responses measured by RECIST at 16 weeks from baseline ]
Complete response plus partial response
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02843165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • 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)
  • 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
  • Overall Survival [ Time Frame: Assessed at 5 years ]
    The time from starting treatment until death due to any cause.
  • 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.
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
Official Title  ICMJE Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Cancer
Intervention  ICMJE
  • Drug: CBI
    Approved CBIs (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
  • 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)
Study Arms  ICMJE
  • Experimental: CBI plus SBRT
    Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
    Intervention: Radiation: CBI plus SBRT
  • Active Comparator: CBI
    Checkpoint blockade immunotherapy (CBI)
    Intervention: Drug: CBI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ceonne Kim (858) 822-0201 cek008@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843165
Other Study ID Numbers  ICMJE 151570
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Sharabi, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Sharabi, MD, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP