Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
NCT ID: NCT01582672
Last Updated: 2018-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
462 participants
INTERVENTIONAL
2012-11-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
AGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
Standard Treatment
Standard treatment for Renal Cell Carcinoma
Interventions
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Standard Treatment
Standard treatment for Renal Cell Carcinoma
AGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled for cytoreductive or partial nephrectomy
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
Exclusion Criteria
2. Requirement for systemic chronic immunosuppressive drugs or corticosteroids
3. Evidence of brain metastases prior to nephrectomy
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
18 Years
ALL
No
Sponsors
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Argos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Figlin, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Christopher G Wood, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Marietta, Georgia, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Springfield, Illinois, United States
Greenwood, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
East Syracuse, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Middletown, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Allentown, Pennsylvania, United States
Danville, Pennsylvania, United States
Easton, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Myrtle Beach, South Carolina, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, , Canada
Hradec Králové, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Roma, , Italy
Rome, , Italy
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Vigo, , Spain
Cambridge, , United Kingdom
Norwich, , United Kingdom
Preston, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2012-000871-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AGS-003-007
Identifier Type: -
Identifier Source: org_study_id
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