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

NCT01582672 | Terminated Phase 3 DMC

• 2 other identifiers: AGS-003-0072012-000871-17
• Study Type: interventional
• Target: 462
• Locations: 8 countries
• Sites: 125

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.

Conditions

Advanced Renal Cell Carcinoma; Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Keywords

RCC; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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 Outcomes (3)

• Progression Free Survival

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

• Tumor Response

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

• Monitor treatment emergent adverse events between both arms

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

Study Arms (2)

AGS-003 + Standard Treatment

EXPERIMENTAL

Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.

Biological: AGS-003

Standard Treatment

ACTIVE COMPARATOR

Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.

Drug: Standard Treatment

Interventions

Standard Treatment DRUG

Standard treatment for Renal Cell Carcinoma

Also known as: Sunitinib

Standard Treatment

AGS-003 BIOLOGICAL

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

AGS-003 + Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis or clinical signs of advanced RCC
• Scheduled for cytoreductive or partial nephrectomy

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (125)

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Scottsdale, Arizona, 85259, United States

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Little Rock, Arkansas, 72205, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90024, United States

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Los Angeles, California, 90048, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80211, United States

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Miami, Florida, 33140, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912, United States

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Marietta, Georgia, 30060, United States

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Boise, Idaho, 83706, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60612, United States

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Maywood, Illinois, 60153, United States

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Springfield, Illinois, 62702, United States

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Greenwood, Indiana, 46143, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46237, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Wichita, Kansas, 67226, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21204, United States

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Boston, Massachusetts, 02114, United States

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Burlington, Massachusetts, 01805, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Grand Rapids, Michigan, 49503, United States

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Lansing, Michigan, 48912, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68130, United States

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Omaha, Nebraska, 68198, United States

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Lebanon, New Hampshire, 03756, United States

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Hackensack, New Jersey, 07601, United States

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Albuquerque, New Mexico, 87131, United States

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Albany, New York, 12208, United States

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East Syracuse, New York, 13057, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Stony Brook, New York, 11794, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27710, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45212, United States

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Middletown, Ohio, 45042, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97239, United States

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Springfield, Oregon, 97477, United States

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Allentown, Pennsylvania, 18103, United States

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Danville, Pennsylvania, 17822, United States

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Easton, Pennsylvania, 18045, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19111, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Providence, Rhode Island, 02906, United States

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Charleston, South Carolina, 29425, United States

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Greenville, South Carolina, 29605, United States

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Myrtle Beach, South Carolina, 29572, United States

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Sioux Falls, South Dakota, 57105, United States

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Nashville, Tennessee, 37215, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78240, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Virginia Beach, Virginia, 23462, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98109, United States

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Milwaukee, Wisconsin, 53215, United States

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Milwaukee, Wisconsin, 53226, United States

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Winnipeg, Manitoba, R3E 0V9, Canada

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Hamilton, Ontario, L8N4A6, Canada

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London, Ontario, N6A5W9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H8L6, Canada

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Greenfield Park, Quebec, J4V2HI, Canada

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Montreal, Quebec, H2L4M1, Canada

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Montreal, Quebec, H3T1E2, Canada

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Québec, G1R3S1, Canada

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Hradec Králové, 50005, Czechia

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Liberec, 46063, Czechia

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Olomouc, 77520, Czechia

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Prague, 10034, Czechia

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Prague, 18081, Czechia

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Budapest, H-1062, Hungary

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Budapest, H-1122, Hungary

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Debrecen, H-4032, Hungary

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Haifa, 31096, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Rehovot, 76100, Israel

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Tel Litwinsky, 52621, Israel

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Ẕerifin, 70300, Israel

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Roma, 00152, Italy

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Rome, 00144, Italy

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Badalona, 08916, Spain

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Barcelona, 08003, Spain

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Barcelona, 08035, Spain

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Madrid, 28033, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Seville, 41013, Spain

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Valencia, 46009, Spain

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Vigo, 36204, Spain

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Cambridge, CB20QQ, United Kingdom

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Norwich, NR47UY, United Kingdom

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Preston, PR29HT, United Kingdom

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Related Publications (1)

• 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.

  PMID: 32034074 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Figlin, MD, FACP

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Christopher G Wood, MD, FACP

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 23, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 14, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (88); GB (3); CZ (5); ES (9); IL (6); CA (9); HU (3); IT (2)