Renal Cell CarcinomaPhase 2NCT00678119
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
A Phase 2 study testing AGS-003 and Sunitinib in people with Renal Cell Carcinoma, run by Argos Therapeutics at 14 sites in 2 countries.
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. 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 and Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2008to May 2012
- Phase
- Phase 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
- 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:
- Newly diagnosed advanced stage RCC.
- Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
- Measurable disease.
- Candidate for sunitinib treatment as labeled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
- No brain metastases detected by MRI.
- Normal renal function in the contralateral kidney.
- Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
- 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.
- Clinically acceptable Screening results according to the following specific limits:
- Adequate hematologic function.
- Adequate renal and hepatic function.
- Adequate coagulation function.
- Normal serum calcium.
- Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
- Voluntary informed consent given to participate in the study.
Who cannot join
- Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:
- Nephrectomy for RCC therapy is required.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Uncontrolled hypertension.
- Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
- Prior systemic therapy for advanced stage RCC.
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- Active autoimmune disease.
- Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
- Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
- Active, acute, or chronic clinically significant infections.
- Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
- Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
- History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Body weight less than 30 kg.
- Pregnancy or lactation.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Emory University
Atlanta, Georgia, 30322
Carolina's Medical Center / Blumenthal Cancer Center
Charlotte, North Carolina, 28204
Barrett Cancer
Cincinnati, Ohio, 45267
CORTPA
Dallas, Texas, 75230
The Urology Center of Colorado
Denver, Colorado, 80211
City of Hope
Duarte, California, 91010
The Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Hospital
Kansas City, Kansas, 66160
UCLA
Los Angeles, California, 90095
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Urology of Virginia-Sentara Medical Group
Norfolk, Virginia, 23502
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T1E2
Princess Margaret Hospital
Toronto, Ontario, M5G2M9
About this study
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
Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.
Read the 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
- Conditions
- Renal Cell Carcinoma
- Being tested
- AGS-003, Sunitinib
- Keywords
- Kidney cancer, Renal cancer, Renal Cell Carcinoma
- 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
Dendritic cell Immunotherapeutic
SunitinibDrug
Also called Sutent
An approved drug for the treatment of RCC
| Study group | Role | What they receive |
|---|---|---|
| 1: AGS-003+sunitinib | Experimental | Single arm study AGS-003 plus sunitinib Receives: Biological: AGS-003; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (1)
The monitoring of clinical activity, immune response and safety across multiple doses.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Miesowicz, Study director, Argos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678119
- Sponsor's protocol ID
- AGS-003-006
- Status last verified
- Jul 2013
- First submitted
- 14 May 2008
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amin A, Dudek AZ, Logan TF, Lance RS, Holzbeierlein JM, Knox JJ, Master VA, Pal SK, Miller WH Jr, Karsh LI, Tcherepanova IY, DeBenedette MA, Williams WL, Plessinger DC, Nicolette CA, Figlin RA. Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results. J Immunother Cancer. 2015 Apr 21;3:14. doi: 10.1186/s40425-015-0055-3. eCollection 2015.
PubMed 25901286
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00678119
- Acronym / sponsor ID
- AGS-003-006
- Conditions
- Renal Cell Carcinoma
- Keywords
- Kidney cancer, Renal cancer, Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 May 2008 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: AGS-003+sunitinib | Experimental | Biological: AGS-003, Drug: SunitinibSingle arm study AGS-003 plus sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Newly diagnosed advanced stage RCC.
- Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
- Measurable disease.
- Candidate for sunitinib treatment as labeled.
Key exclusion criteria (16 listed)
- Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:
- Nephrectomy for RCC therapy is required.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Uncontrolled hypertension.
- Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
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-003Dendritic cell Immunotherapeutic | Biological | 1: AGS-003+sunitinib |
| SunitinibAlso: SutentAn approved drug for the treatment of RCC | Drug | 1: AGS-003+sunitinib |
Primary outcome
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
1 secondary outcome
The monitoring of clinical activity, immune response and safety across multiple doses.
Time frame: 24 weeks
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 15 Jul 2013.
- Derived from this study: PubMed 25901286Amin A, Dudek AZ, Logan TF, Lance RS, Holzbeierlein JM, Knox JJ, Master VA, Pal SK, Miller WH Jr, Karsh LI, Tcherepanova IY, DeBenedette MA, Williams WL, Plessinger DC, Nicolette CA, Figlin RA. Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results. J Immunother Cancer. 2015 Apr 21;3:14. doi: 10.1186/s40425-015-0055-3. eCollection 2015.
- Argos Therapeutics WebsiteLink provided by the sponsor.
- Kidney Cancer AssociationLink provided by the sponsor.
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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.
Fred Miesowicz study director
Argos Therapeutics
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGS-003 and Sunitinib in people with Renal Cell Carcinoma, run by Argos Therapeutics at 14 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 18 inclusion and 16 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 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 phase mean?
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678119, which also lists 1 linked publication.
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 15 Jul 2013.