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

June 13, 2018 updated by: Argos Therapeutics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

462

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R3S1
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
      • London, Ontario, Canada, N6A5W9
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H8L6
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V2HI
      • Montreal, Quebec, Canada, H2L4M1
      • Montreal, Quebec, Canada, H3T1E2
  • Czechia
      • Hradec Kralove, Czechia, 50005
      • Liberec, Czechia, 46063
      • Olomouc, Czechia, 77520
      • Prague, Czechia, 10034
      • Praha 8, Czechia, 18081
  • Hungary
      • Budapest, Hungary, H-1122
      • Budapest, Hungary, H-1062
      • Debrecen, Hungary, H-4032
  • Israel
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Rehovot, Israel, 76100
      • Tel Hashomer, Israel, 52621
      • Zerifin, Israel, 70300
  • Italy
      • Roma, Italy, 00152
      • Rome, Italy, 00144
  • Spain
      • Badalona, Spain, 08916
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28046
      • Madrid, Spain, 28033
      • Madrid, Spain, 28050
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46009
      • Vigo, Spain, 36204
  • United Kingdom
      • Cambridge, United Kingdom, CB20QQ
      • Norwich, United Kingdom, NR47UY
      • Preston, United Kingdom, PR29HT
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90024
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80909
      • Denver, Colorado, United States, 80211
    • Florida
      • Miami, Florida, United States, 33140
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30912
      • Marietta, Georgia, United States, 30060
    • Idaho
      • Boise, Idaho, United States, 83706
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Maywood, Illinois, United States, 60153
      • Springfield, Illinois, United States, 62702
    • Indiana
      • Greenwood, Indiana, United States, 46143
      • Indianapolis, Indiana, United States, 46202
      • Indianapolis, Indiana, United States, 46237
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
      • Wichita, Kansas, United States, 67226
    • Louisiana
      • Metairie, Louisiana, United States, 70006
      • New Orleans, Louisiana, United States, 70112
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Burlington, Massachusetts, United States, 01805
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
      • Grand Rapids, Michigan, United States, 49503
      • Lansing, Michigan, United States, 48912
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68198
      • Omaha, Nebraska, United States, 68130
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Albany, New York, United States, 12208
      • East Syracuse, New York, United States, 13057
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
      • Stony Brook, New York, United States, 11794
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Durham, North Carolina, United States, 27710
      • Raleigh, North Carolina, United States, 27607
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45212
      • Middletown, Ohio, United States, 45042
      • Toledo, Ohio, United States, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97213
      • Springfield, Oregon, United States, 97477
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Danville, Pennsylvania, United States, 17822
      • Easton, Pennsylvania, United States, 18045
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19111
      • Pittsburgh, Pennsylvania, United States, 15232
      • Pittsburgh, Pennsylvania, United States, 15212
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Greenville, South Carolina, United States, 29605
      • Myrtle Beach, South Carolina, United States, 29572
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Nashville, Tennessee, United States, 37215
    • Texas
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78240
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Virginia Beach, Virginia, United States, 23462
    • Washington
      • Seattle, Washington, United States, 98101
      • Seattle, Washington, United States, 98109
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Sunitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From date of subject randomization to date of progression; assessed up to 42 months
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.
From date of subject randomization to date of progression; assessed up to 42 months
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.
From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (ESTIMATE)

April 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGS-003-007
  • 2012-000871-17 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Clinical Trials on AGS-003

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe