Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

Thank you

Trial Information

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

The purpose of this study is to investigate an anticancer immunotherapeutic, AGS-003, when
used in combination with sunitinib (the treatment regimen) in a single-stage, Phase II
design in subjects with previously untreated advanced stage RCC after nephrectomy/excisional
biopsy/metastasectomy. AGS-003 is formulated using mature DCs co-electroporated with CD40L
IVT RNA and autologous total tumor RNA

Inclusion Criteria:

Male and female subjects ≥18 years of age with newly diagnosed advanced stage RCC will be
eligible for inclusion in this study if all of the following criteria apply:

1. Newly diagnosed advanced stage RCC.

2. Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible
for excisional biopsy/metastasectomy.

3. Measurable disease.

4. Candidate for sunitinib treatment as labeled.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6. Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.

7. No brain metastases detected by MRI.

8. Normal renal function in the contralateral kidney.

9. Able to abstain from taking prohibited prescription or prohibited non-prescription

10. 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.

11. Clinically acceptable Screening results according to the following specific limits:

- Adequate hematologic function.

- Adequate renal and hepatic function.

- Adequate coagulation function.

12. Normal serum calcium.

13. Ability to communicate effectively with study personnel; considered reliable,
willing, and cooperative in terms of compliance with the Protocol requirements.

14. Voluntary informed consent given to participate in the study.

Exclusion Criteria:

Subjects will NOT be eligible for inclusion in this study if any of the following criteria

1. Nephrectomy for RCC therapy is required.

2. Any serious medical condition or illness considered by the investigator to constitute
an unwarranted high risk for investigational treatment.

3. Uncontrolled hypertension.

4. Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).

5. Prior systemic therapy for advanced stage RCC.

6. Active autoimmune disease.

7. Prior history of malignancy other than RCC within the preceding 5 years, except for
adequately treated cervical cancer or non-melanoma skin cancer.

8. Use of prohibited prescription or prohibited non-prescription drugs during 2 months
prior to entry into the study.

9. Active, acute, or chronic clinically significant infections.

10. Use of another investigational drug or participation in any investigational drug
study within the 28 days prior to the start of study enrollment.

11. Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional

12. History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring

13. Known hypersensitivity to dimethyl sulfoxide (DMSO).

14. Body weight less than 30 kg.

15. Pregnancy or lactation.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Fred Miesowicz

Investigator Role:

Study Director

Investigator Affiliation:

Argos Therapeutics


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

May 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney cancer
  • Renal cancer
  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



University of Iowa Iowa City, Iowa  52242
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
City of Hope Duarte, California  91010
Emory University Atlanta, Georgia  30322
UCLA Los Angeles, California  90095
University of Kansas Hospital Kansas City, Kansas  66160
The Urology Center of Colorado Denver, Colorado  80211
The Indiana University Cancer Center Indianapolis, Indiana  46202
Carolina's Medical Center / Blumenthal Cancer Center Charlotte, North Carolina  28204
Barrett Cancer Cincinnati, Ohio  45267
CORTPA Dallas, Texas  75230
Urology of Virginia-Sentara Medical Group Norfolk, Virginia  23502