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

Phase 2

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: AGS-003; Drug: Sunitinib

• Registration Number: NCT00678119
• Lead Sponsor: Argos Therapeutics

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.

Detailed 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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-07
• Disposition First Submitted: 2013-07-09
• Disposition First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-11
• Disposition First Posted: 2013-07-12
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1: AGS-003+sunitinib	AGS-003	Single arm study AGS-003 plus sunitinib
1: AGS-003+sunitinib	Sunitinib	Single arm study AGS-003 plus sunitinib

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The monitoring of clinical activity, immune response and safety across multiple doses.	24 weeks

Trial Locations

Locations (14)

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

City of Hope; 🇺🇸 Duarte, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

UCLA; 🇺🇸 Los Angeles, California, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

CORTPA; 🇺🇸 Dallas, Texas, United States

Urology of Virginia-Sentara Medical Group; 🇺🇸 Norfolk, Virginia, United States

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

The Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

The Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

Barrett Cancer; 🇺🇸 Cincinnati, Ohio, United States

Carolina's Medical Center / Blumenthal Cancer Center; 🇺🇸 Charlotte, North Carolina, United States