AzTrials
AzTrials

Advanced Renal Cell CarcinomaPhase 3ADAPTNCT01582672

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

A Phase 3 study testing Standard Treatment and AGS-003 in people with Advanced Renal Cell Carcinoma and Renal Cell Carcinoma, run by Argos Therapeutics at 125 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Treatment and AGS-003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
462 participants
Where
125 sitesin 8 countries
Study dates
Nov 2012to Apr 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis or clinical signs of advanced RCC
  • Scheduled for cytoreductive or partial nephrectomy
  • Advanced disease, histologically assessed as RCC, with predominantly clear cell histology
  • Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1
  • Subjects who are candidates for standard first-line therapy initiating with sunitinib
  • Time from diagnosis to treatment < 1 year
Show all 14Show fewer
  • Karnofsky performance status (KPS) ≥ 70%
  • Life expectancy of 6 months or greater
  • 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
  • Adequate hematologic, renal, hepatic, and coagulation function
  • 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
  • Normal ECG or clinically non-significant finding(s) at Screening
  • Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Who cannot join

  • Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions
  • Requirement for systemic chronic immunosuppressive drugs or corticosteroids
  • Evidence of brain metastases prior to nephrectomy
  • Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
  • 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
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
Show all 22Show fewer
  • Patients with 4 or more of the following risk factors:
  • Hgb < LLN
  • Corrected calcium > 10.0 mg/dL
  • KPS < 80%
  • Neutrophils > ULN
  • Platelets > ULN
  • Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)
  • NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
  • Clinically significant cardiovascular conditions within 3 months prior to Randomization
  • Significant gastrointestinal abnormalities
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Active autoimmune disease or condition requiring chronic immunosuppressive therapy
  • Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C
  • Current treatment with an investigational therapy on another clinical trial
  • Pregnancy or breastfeeding
  • Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment

Trial locations and contacts

125 sites in 8 countries.

125 sites in 8 countries

United States88 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Boise, Idaho, 83706

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Dallas, Texas, 75231

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Denver, Colorado, 80211

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Durham, North Carolina, 27710

  • Study site

    East Syracuse, New York, 13057

  • Study site

    Easton, Pennsylvania, 18045

  • Study site

    Grand Rapids, Michigan, 49503

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Greenwood, Indiana, 46143

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    La Jolla, California, 92093

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90024

  • Study site

    Los Angeles, California, 90048

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33140

  • Study site

    Middletown, Ohio, 45042

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Nashville, Tennessee, 37215

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78240

  • Study site

    San Francisco, California, 94115

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    Seattle, Washington, 98101

  • Study site

    Seattle, Washington, 98109

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    Springfield, Illinois, 62702

  • Study site

    Springfield, Oregon, 97477

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stony Brook, New York, 11794

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33612

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    Wichita, Kansas, 67226

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada9 sites

  • Study site

    Greenfield Park, Quebec, J4V2HI

  • Study site

    Hamilton, Ontario, L8N4A6

  • Study site

    London, Ontario, N6A5W9

  • Study site

    Montreal, Quebec, H2L4M1

  • Study site

    Montreal, Quebec, H3T1E2

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1H8L6

  • Study site

    Québec, G1R3S1

  • Study site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Spain9 sites

  • Study site

    Badalona, 08916

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28050

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46009

  • Study site

    Vigo, 36204

Other trials in Spain

Israel6 sites

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Rehovot, 76100

  • Study site

    Tel HaShomer, 52621

  • Study site

    Tsrifin, 70300

Other trials in Israel

Czechia5 sites

  • Study site

    Hradec Králové, 50005

  • Study site

    Liberec, 46063

  • Study site

    Olomouc, 77520

  • Study site

    Prague, 10034

  • Study site

    Prague, 18081

Other trials in Czechia

Hungary3 sites

  • Study site

    Budapest, H-1062

  • Study site

    Budapest, H-1122

  • Study site

    Debrecen, H-4032

Other trials in Hungary

United Kingdom3 sites

  • Study site

    Cambridge, CB20QQ

  • Study site

    Norwich, NR47UY

  • Study site

    Preston, PR29HT

Other trials in United Kingdom

Italy2 sites

  • Study site

    Roma, 00152

  • Study site

    Rome, 00144

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Standard Treatment, AGS-003
Keywords
RCC, Kidney Cancer
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard TreatmentDrug

    Also called Sunitinib

    Standard treatment for Renal Cell Carcinoma

  • AGS-003Biological

    Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.

Study groups in NCT01582672
Study groupRoleWhat they receive
AGS-003 + Standard TreatmentExperimentalSubjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
Receives: Biological: AGS-003
Standard TreatmentActive comparatorSubjects on this arm will receive standard treatment for Renal Cell Carcinoma.
Receives: Drug: Standard Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Duration from randomization to death

    Measured: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study

Secondary outcomes (3)

  1. Progression Free Survival

    Measured: From date of subject randomization to date of progression; assessed up to 42 months

  2. Tumor Response

    Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.

    Measured: From date of subject randomization to date of progression; assessed up to 42 months

  3. Monitor treatment emergent adverse events between both arms

    Compare adverse events between both arms.

    Measured: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionApr 2018
  4. Study completionApr 2018

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582672
Sponsor's protocol ID
AGS-003-007
Other IDs
2012-000871-17
Acronym
ADAPT
Status last verified
Jun 2017
First submitted
19 Apr 2012
Last updated
14 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Figlin RA, Tannir NM, Uzzo RG, Tykodi SS, Chen DYT, Master V, Kapoor A, Vaena D, Lowrance W, Bratslavsky G, DeBenedette M, Gamble A, Plachco A, Norris MS, Horvatinovich J, Tcherepanova IY, Nicolette CA, Wood CG; ADAPT study group. Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 May 15;26(10):2327-2336. doi: 10.1158/1078-0432.CCR-19-2427. Epub 2020 Feb 7.

    PubMed 32034074

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard Treatment and AGS-003 in people with Advanced Renal Cell Carcinoma and Renal Cell Carcinoma, run by Argos Therapeutics at 125 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Canada, Spain, Israel, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01582672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in