Renal Cell CarcinomaPhase 1/2NCT00272649
Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
A Phase 1/2 study testing AGS-003 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 10 sites in 2 countries.
Trial summary
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- AGS-003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2006to Feb 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a new diagnosis of metastatic renal cell carcinoma;
- Measurable disease
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
- ECOG of 0 or 1;
- Free of brain metastases by CT or MRI;
Show all 11Show fewer
- Normal renal function in contralateral kidney;
- Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
- Clinically acceptable screening results.
- No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
- No active autoimmune disease
Who cannot join
None listed.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Emory University
Atlanta, Georgia, 30322
Univ. of Colorado Health Science Center - Division of Medical Oncology
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, 28204
The Indiana University Cancer Center/IUPUI
Indianapolis, Indiana, 46202
Nevada Cancer Institute
Las Vegas, Nevada, 89135
UCLA Kidney Cancer Program
Los Angeles, California, 90095-7207
Earle A. Chiles Research Institute
Portland, Oregon, 97213-2933
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Princess Margaret Hospital
Toronto, Ontario, MG5 2M9
About this study
Official title: A Phase I/II Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer
Read the detailed description
In this study, a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study (clinical protocol MB-002-003). While both processes are based on individual subject autologous tumor RNA and autologous monocyte derived DCs, the maturation of DCs in this newly modified process involves an altered regimen of culture with cytokines. In addition, huCD40L mRNA is added to the autologous expanded tumor total mRNA for electroporation. These changes promise a much improved migration, and activity profile of the DC-Immunotherapeutic product in RCC subjects.
- Conditions
- Renal Cell Carcinoma
- Being tested
- AGS-003
- Keywords
- Kidney cancer, Renal cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-003Biological
Also called Dendritic Cell Immunotherapeutic
Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Single Arm study Receives: Biological: AGS-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Measured: 24 weeks
Secondary outcomes (1)
Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression
Measured: 24 weeks plus follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry Chew, MD, Study chair, Argos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272649
- Sponsor's protocol ID
- AGS-003-004
- Other IDs
- Bukowski-8077, Logan-0506-05, Drabkin-05-0167, White-04-05-01A, Figlin-05-03-099-01
- Status last verified
- Mar 2013
- First submitted
- 6 Jan 2006
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00272649
- Acronym / sponsor ID
- AGS-003-004
- Conditions
- Renal Cell Carcinoma
- Keywords
- Kidney cancer, Renal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer
Detailed description
In this study, a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study (clinical protocol MB-002-003). While both processes are based on individual subject autologous tumor RNA and autologous monocyte derived DCs, the maturation of DCs in this newly modified process involves an altered regimen of culture with cytokines. In addition, huCD40L mRNA is added to the autologous expanded tumor total mRNA for electroporation. These changes promise a much improved migration, and activity profile of the DC-Immunotherapeutic product in RCC subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: AGS-003Single Arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a new diagnosis of metastatic renal cell carcinoma;
- Measurable disease
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
- ECOG of 0 or 1;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-003Also: Dendritic Cell ImmunotherapeuticDendritic cell, autologous cellular immunotherapy. (Arcelis platform) | Biological | Single Arm |
Primary outcome
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Time frame: 24 weeks
1 secondary outcome
Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression
Time frame: 24 weeks plus follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
- Kidney Cancer AssociationLink provided by the sponsor.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Chew, MD study chair
Argos Therapeutics
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AGS-003 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.