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

July 11, 2013 updated by: Argos Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Jewish General Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90095
        • UCLA
    • Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • The Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina's Medical Center / Blumenthal Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Barrett Cancer
    • Texas
      • Dallas, Texas, United States, 75230
        • CORTPA
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Urology of Virginia-Sentara Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1: AGS-003+sunitinib
Single arm study AGS-003 plus sunitinib
Biological: AGS-003
Dendritic cell Immunotherapeutic
Drug: Sunitinib
An approved drug for the treatment of RCC
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The monitoring of clinical activity, immune response and safety across multiple doses.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argos Therapeutics

Investigators

  • Study Director: Fred Miesowicz, Argos Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (ESTIMATE)

May 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGS-003-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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