Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment
A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib
1 other identifier
interventional
25
2 countries
14
Brief Summary
Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2008
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 15, 2013
July 1, 2013
4.3 years
May 14, 2008
July 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met.
24 weeks
Secondary Outcomes (1)
The monitoring of clinical activity, immune response and safety across multiple doses.
24 weeks
Study Arms (1)
1: AGS-003+sunitinib
EXPERIMENTALSingle arm study AGS-003 plus sunitinib
Interventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed advanced stage RCC.
- Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
- Measurable disease.
- Candidate for sunitinib treatment as labeled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
- No brain metastases detected by MRI.
- Normal renal function in the contralateral kidney.
- Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
- Use of appropriate birth control methods for the duration of the study for women of childbearing potential and men with female partners of childbearing potential.
- Clinically acceptable Screening results according to the following specific limits:
- Adequate hematologic function.
- Adequate renal and hepatic function.
- Adequate coagulation function.
- Normal serum calcium.
- +2 more criteria
You may not qualify if:
- Nephrectomy for RCC therapy is required.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Uncontrolled hypertension.
- Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
- Prior systemic therapy for advanced stage RCC.
- Active autoimmune disease.
- Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
- Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
- Active, acute, or chronic clinically significant infections.
- Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
- Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
- History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Body weight less than 30 kg.
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
City of Hope
Duarte, California, 91010, United States
UCLA
Los Angeles, California, 90095, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Emory University
Atlanta, Georgia, 30322, United States
The Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Carolina's Medical Center / Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Barrett Cancer
Cincinnati, Ohio, 45267, United States
CORTPA
Dallas, Texas, 75230, United States
Urology of Virginia-Sentara Medical Group
Norfolk, Virginia, 23502, United States
Princess Margaret Hospital
Toronto, Ontario, M5G2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Related Publications (1)
Amin A, Dudek AZ, Logan TF, Lance RS, Holzbeierlein JM, Knox JJ, Master VA, Pal SK, Miller WH Jr, Karsh LI, Tcherepanova IY, DeBenedette MA, Williams WL, Plessinger DC, Nicolette CA, Figlin RA. Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results. J Immunother Cancer. 2015 Apr 21;3:14. doi: 10.1186/s40425-015-0055-3. eCollection 2015.
PMID: 25901286DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fred Miesowicz
Argos Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2008
First Posted
May 15, 2008
Study Start
January 1, 2008
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 15, 2013
Record last verified: 2013-07