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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678119
• Other study ID #: AGS-003-006
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: July 11, 2013
• Start date: January 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Argos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 drugs.

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 apply:

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 biopsy/metastasectomy.

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

13. Known hypersensitivity to dimethyl sulfoxide (DMSO).

14. Body weight less than 30 kg.

15. Pregnancy or lactation.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• AGS-003
Dendritic cell Immunotherapeutic

Drug:
• Sunitinib
An approved drug for the treatment of RCC

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Emory University	Atlanta	Georgia
United States	Carolina's Medical Center / Blumenthal Cancer Center	Charlotte	North Carolina
United States	Barrett Cancer	Cincinnati	Ohio
United States	CORTPA	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	City of Hope	Duarte	California
United States	The Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Hospital	Kansas City	Kansas
United States	UCLA	Los Angeles	California
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Urology of Virginia-Sentara Medical Group	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Argos Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The monitoring of clinical activity, immune response and safety across multiple doses.		24 weeks	Yes

External Links

•   Argos Therapeutics Website
•   Kidney Cancer Association