Trial record 2 of 5 for:    AGS-003

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.
Verified April 2014 by Argos Therapeutics
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT01582672
First received: April 19, 2012
Last updated: April 22, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582672

Contacts
Contact: Adapt Study Team contact@adapt-study.com

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic - Scottsdale Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Samuel Oschin Cancer Center at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90024
California Pacific Medical Center Research Institute Recruiting
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Advanced Urology, P.C. Recruiting
Parker, Colorado, United States, 80134
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
United States, Florida
Specialists in Urology Recruiting
Naples, Florida, United States, 34102
MD Anderson - Orlando Recruiting
Orlando, Florida, United States, 32806
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univeristy Hospital Recruiting
Atlanta, Georgia, United States, 30322
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Idaho Urologic Institute Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Vanguard Health Chicago Recruiting
Berwyn, Illinois, United States, 60402
University of Illinois Hospital Recruiting
Chicago, Illinois, United States, 60612
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Edward Hines Jr VA Hospital Recruiting
Hines, Illinois, United States, 60141
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Edward H. Kaplan and Associates Recruiting
Skokie, Illinois, United States, 60076
Southern Illinois University - Simmons Cancer Institute Recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Urology of Indiana Recruiting
Greenwood, Indiana, United States, 46143
Franciscan St. Francis Health - Franciscan Physician Network Oncology and Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Jewish Hospital & St. Mary's Healthcare Recruiting
Lousiville, Kentucky, United States, 40245
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
Tulane University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center (GBMC) Recruiting
Baltimore, Maryland, United States, 21204
University of Maryland, Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Lahey Clinic Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Karmanos Cancer Institute - Wayne State University School of Medicine Recruiting
Detroit, Michigan, United States, 48201
Cancer and Hematology Clinics of Western Michigan - Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Urology Cancer Center and GU Research Network Recruiting
Omaha, Nebraska, United States, 68130
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center At Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico School of Medicine Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Hematology Oncology Associates of CNY Recruiting
East Syracuse, New York, United States, 13057
New York Medical College - Urology Center of Westchester Recruiting
Hawthorne, New York, United States, 10532
North Shore Long Island Jewish Hospital System - Monter Cancer Center Recruiting
New Hyde Park, New York, United States, 11040
Mount Sinai School of Medicine - Medical Center Recruiting
New York, New York, United States, 10029
NYU Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Strong Memorial Hospital - University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Associated Medical Professionals of New York Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Associated Urologists of North Carolina Recruiting
Raleigh, North Carolina, United States, 27607
Wake Forest Baptist Health - Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
TriState Urologic Services PSC Inc. The Urology Group Recruiting
Cincinnati, Ohio, United States, 45212
Signal Point Clinical Research Center, LLC Recruiting
Middletown, Ohio, United States, 45042
Mercy Cancer Center Recruiting
Toledo, Ohio, United States, 43623
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Oregon Urology Institute Not yet recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
St. Luke's Hospital - Anderson Campus Recruiting
Easton, Pennsylvania, United States, 18045
Penn State - Hershey Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Urological Associates of Lancaster Recruiting
Lancaster, Pennsylvania, United States, 17601
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Greenville Hospital System - Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt University School of Medicine Recruiting
Nashville, Tennessee, United States, 37215
United States, Texas
Urology Clinics of North Texas Recruiting
Dallas, Texas, United States, 75231
University of Texas Medical Branch - Galveston Recruiting
Galveston, Texas, United States, 77555
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
Seattle Cancer Center Recruiting
Seattle, Washington, United States, 98109
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98402
United States, Wisconsin
Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Aurora Health Care Recruiting
Milwaulkee, Wisconsin, United States, 53215
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
St. Josephs Healthcare - McMaster Institute Urology Recruiting
Hamilton, Ontario, Canada, L8N4A6
R S McLaughlin Durham - Regional Cancer Centre Recruiting
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Hopital Notre Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L4M1
Czech Republic
Fakutni nemocnice Hadrec Kralove Recruiting
Hradec Kralove, Czech Republic, 50005
Fakultni nemocnice Olomouc Recruiting
Olomouc, Czech Republic, 77520
Fakultni nemocnice Kralovske Vinohrady Recruiting
Prague, Czech Republic, 10034
Nemocnice Na Bulovce Recruiting
Praha 8, Czech Republic, 18081
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel, 84101
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Hadassah Hebrew University Medical Center Ein Karem Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center Beilinson Campus Recruiting
Petah Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Italy
San Camillo Forlanini Hospital Recruiting
Roma, Italy, 00152
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Vall d' Hebron Recruiting
Barcelona, Spain, 08035
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Hospital La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Complejo Hospitalario Universitario de Vigo Recruiting
Vigo, Spain, 36204
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB20QQ
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: April 22, 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 April 23, 2014