Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC) (ADAPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Argos Therapeutics
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT01582672
First received: April 19, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Advanced Renal Cell Carcinoma
Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Drug: Standard Treatment
Biological: AGS-003
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Resource links provided by NLM:


Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Duration from randomization to death


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ] [ Designated as safety issue: No ]
  • Tumor Response [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Compare adverse events between both arms.


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
Biological: AGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Active Comparator: Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
Drug: Standard Treatment
Standard treatment for Renal Cell Carcinoma
Other Name: Sunitinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582672

Contacts
Contact: Adapt Study Team 1-877-573-9235 contact@adapt-study.com

  Show 121 Study Locations
Sponsors and Collaborators
Argos Therapeutics
Investigators
Principal Investigator: Robert Figlin, MD, FACP Cedars-Sinai Medical Center
Principal Investigator: Christopher G Wood, MD, FACP M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT01582672     History of Changes
Other Study ID Numbers: AGS-003-007, 2012-000871-17
Study First Received: April 19, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Argos Therapeutics:
RCC
Kidney Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014