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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582672
Recruitment Status : Terminated (Lack of efficacy)
First Posted : April 23, 2012
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
Overall Survival [ Time Frame: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study ]
Duration from randomization to death
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
Overall Survival [ Time Frame: From date of subject randomization to date of death; assessed up to 42 months ]
Duration from randomization to death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • Progression Free Survival [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
  • Tumor Response [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
    Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.
  • Monitor treatment emergent adverse events between both arms [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
    Compare adverse events between both arms.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • Progression Free Survival [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
  • Tumor Response [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
    Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.
  • Monitor for treatment-emergent Adverse Events [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
  • Monitor clinical chemistry, hematology, and urinalysis for changes from safety baseline [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
    Clinical laboratory values will be monitored for changes from safety baseline.
  • Vital Signs [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
    Monitor changes from safety baseline in vital signs
  • Physical Examination [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
    Monitor changes from safety baseline in physical examinations
  • Electrocardiograms [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
    Monitor changes from safety baseline in ECGs
  • Monitor signs and symptoms indicating treatment-emergent autoimmunity [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
Official Title  ICMJE An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Brief Summary This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
Detailed Description This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Standard Treatment
    Standard treatment for Renal Cell Carcinoma
    Other Name: Sunitinib
  • Biological: AGS-003
    Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Study Arms  ICMJE
  • Experimental: AGS-003 + Standard Treatment
    Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
    Intervention: Biological: AGS-003
  • Active Comparator: Standard Treatment
    Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
    Intervention: Drug: Standard Treatment
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 13, 2018)
462
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2012)
450
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria for Tumor Collection:

  1. Diagnosis or clinical signs of advanced RCC
  2. Scheduled for cytoreductive or partial nephrectomy

Key Exclusion Criteria for Tumor Collection:

  1. Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions
  2. Requirement for systemic chronic immunosuppressive drugs or corticosteroids
  3. Evidence of brain metastases prior to nephrectomy

Key Inclusion Criteria for Treatment Study:

  1. Advanced disease, histologically assessed as RCC, with predominantly clear cell histology
  2. Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1
  3. Subjects who are candidates for standard first-line therapy initiating with sunitinib
  4. Time from diagnosis to treatment < 1 year
  5. Karnofsky performance status (KPS) ≥ 70%
  6. Life expectancy of 6 months or greater
  7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
  8. Adequate hematologic, renal, hepatic, and coagulation function
  9. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
  10. Normal ECG or clinically non-significant finding(s) at Screening
  11. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
  12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Key Exclusion Criteria for Treatment Study:

  1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
  2. Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA
  3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
  4. Patients with 4 or more of the following risk factors:

    1. Hgb < LLN
    2. Corrected calcium > 10.0 mg/dL
    3. KPS < 80%
    4. Neutrophils > ULN
    5. Platelets > ULN
  5. Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)
  6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
  7. Clinically significant cardiovascular conditions within 3 months prior to Randomization
  8. Significant gastrointestinal abnormalities
  9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy
  11. Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C
  12. Current treatment with an investigational therapy on another clinical trial
  13. Pregnancy or breastfeeding
  14. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Hungary,   Israel,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01582672
Other Study ID Numbers  ICMJE AGS-003-007
2012-000871-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Argos Therapeutics
Study Sponsor  ICMJE Argos Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Figlin, MD, FACP Cedars-Sinai Medical Center
Principal Investigator: Christopher G Wood, MD, FACP M.D. Anderson Cancer Center
PRS Account Argos Therapeutics
Verification Date June 2017

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