Renal Cell CarcinomaPhase 2NCT01482949
A Rollover Protocol for Subjects Previously Treated With AGS-003
A Phase 2 study testing AGS-003 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy. 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2018
- 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
- Age ≥ 18 years
- Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
- Measurable disease that can be monitored per RECIST throughout the course of study participation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic function, as defined by the following criteria:
- White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)
Show all 22Show fewer
- Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)
- Platelets ≥ 100,000/µL (≥ 100 x 103/µL)
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Adequate renal and hepatic function, as defined by the following criteria:
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
- Total serum bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
- Adequate coagulation function as defined by the following criteria:
- Prothrombin time (PT) ≤ 1.5 x ULN
- Activated partial thromboplastin time (PTT) < 1.5 x ULN
- Corrected calcium ≤ 11.5 mg/dL
- Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
- Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- No brain metastases detected by magnetic resonance imaging (MRI).
Who cannot join
- Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
- Pregnancy or breastfeeding
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
Read the detailed description
AGS-003-005 is a rollover, open label, Phase II clinical study testing the biologic activity and safety of AGS-003 in subjects who have experienced either partial responses or prolonged stable disease and continue to benefit from ongoing treatment with AGS-003 in protocols AGS-003-004 or AGS-003-006.
Rollover subjects from AGS-003-004 will continue with AGS-003 monotherapy booster dosing until disease progression or until a discontinuation criterion is reached.
Subjects that progress on AGS-003 monotherapy (from the AGS-003-004 protocol) may start sunitinib treatment and re-initiate AGS-003 therapy beginning with the induction phase dosing schedule.
Rollover subjects from AGS-003-006 will continue sunitinib dosing in combination with booster dosing of AGS-003 until disease progression or until a discontinuation criterion is reached.
If a subject has disease progression due to a new tumor lesion, upon consultation between the investigator, Argos representatives and the Argos medical monitor, the subject may be considered for re-manufacture of study product (from the new metastatic lesion) and dosing with this new product in combination with sunitinib beginning with the induction phase dosing schedule.
For those subjects initiating treatment with the induction phase as described above, restaging imaging occurs at screening (baseline), prior to the fifth dose in the induction phase (as applicable) and every 12 weeks during the booster phase (at the start of the sunitinib holiday, 2 weeks prior to the next AGS-003 dose).
For subjects on combination therapy, if dosing with sunitinib is stopped due to sunitinib-related issues, treatment with AGS-003 may continue.
Close-out visits will occur upon disease progression (other than circumstances discussed above which are eligible for re-induction) or upon decision to terminate the study by the sponsor.
Quarterly follow-up for survival for each subject will occur by telephone interview for 1 year following the last AGS-003 administration or study termination.
- Conditions
- Renal Cell Carcinoma
- Being tested
- AGS-003
- Keywords
- RCC, Kidney Cancer, Renal Cancer, Arcelis
- 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-003Drug
Also called Arcelis
Autologous Dendritic Cell Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| AGS-003 in combination with sunitinib | Experimental | Subjects will undergo Induction (AGS-003 every 3 weeks until 5 doses are administered) followed by Booster (AGS-003 at 3 month intervals). Subjects that will begin sunitinib therapy will be on this arm. Receives: Drug: AGS-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Secondary outcomes (11)
Clinical benefit (stable disease or response)
Clinical benefit measured as Stable Disease (SD), Partial Response (PR), and Complete Response (CR) rate to the treatment regimen. Tumor response is verified using standard definitions of RECIST
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Immune function
Analyses of immune function will be performed. This will include, but not limited to, assessment of T cell and antigen presenting cell populations, including effector memory, cytotoxic lymphocytes (CTLs), and regulatory T cells. Blood and plasma specimens for these analyses will be collected at specified time points and is optional for subjects continuing with booster treatments.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Progression Free Survival (PFS)
Evaluate PFS from the date of registration until PFS is reached per RECIST
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Overall Survival (OS)
Evaluate OS from date of registration until date of death.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Treatment-emergent Adverse Events
Monitor incidence of treatment-emergent Adverse Events.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline
Clinical laboratory values will be monitored for changes from baseline.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Physical Examinations
Monitor changes from baseline in physical examinations
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Vital Signs
Monitor changes from baseline in vital signs
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor signs and symptoms indicating treatment-emergent autoimmunity
Autoimmunity evaluations will be measured by clinical signs and symptoms (e.g., rash, cytopenias, and arthralgias) and by laboratory assessments. These assessments will be monitored as long as the subject is receiving AGS-003.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor for lymph node adenopathy
The draining lymph nodes (axillary and inguinal) will be evaluated for changes from baseline in size, tenderness, or inflammation. These assessments will be monitored as long as the subject is receiving AGS-003.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Injection Site Reaction
Monitor changes from baseline in injection site reactions.
Measured: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Lack of efficacy
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee F Allen, M.D., Ph.D., Study director, Argos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482949
- Sponsor's protocol ID
- AGS-003-005
- Status last verified
- Jun 2018
- First submitted
- 17 Nov 2011
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006
- ClinicalTrials.gov ID
- NCT01482949
- Acronym / sponsor ID
- AGS-003-005
- Conditions
- Renal Cell Carcinoma
- Keywords
- RCC, Kidney Cancer, Renal Cancer, Arcelis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 1 Dec 2011 (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 study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
Detailed description
AGS-003-005 is a rollover, open label, Phase II clinical study testing the biologic activity and safety of AGS-003 in subjects who have experienced either partial responses or prolonged stable disease and continue to benefit from ongoing treatment with AGS-003 in protocols AGS-003-004 or AGS-003-006.
Rollover subjects from AGS-003-004 will continue with AGS-003 monotherapy booster dosing until disease progression or until a discontinuation criterion is reached.
Subjects that progress on AGS-003 monotherapy (from the AGS-003-004 protocol) may start sunitinib treatment and re-initiate AGS-003 therapy beginning with the induction phase dosing schedule.
Rollover subjects from AGS-003-006 will continue sunitinib dosing in combination with booster dosing of AGS-003 until disease progression or until a discontinuation criterion is reached.
If a subject has disease progression due to a new tumor lesion, upon consultation between the investigator, Argos representatives and the Argos medical monitor, the subject may be considered for re-manufacture of study product (from the new metastatic lesion) and dosing with this new product in combination with sunitinib beginning with the induction phase dosing schedule.
For those subjects initiating treatment with the induction phase as described above, restaging imaging occurs at screening (baseline), prior to the fifth dose in the induction phase (as applicable) and every 12 weeks during the booster phase (at the start of the sunitinib holiday, 2 weeks prior to the next AGS-003 dose).
For subjects on combination therapy, if dosing with sunitinib is stopped due to sunitinib-related issues, treatment with AGS-003 may continue.
Close-out visits will occur upon disease progression (other than circumstances discussed above which are eligible for re-induction) or upon decision to terminate the study by the sponsor.
Quarterly follow-up for survival for each subject will occur by telephone interview for 1 year following the last AGS-003 administration or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGS-003 in combination with sunitinib | Experimental | Drug: AGS-003Subjects will undergo Induction (AGS-003 every 3 weeks until 5 doses are administered) followed by Booster (AGS-003 at 3 month intervals). Subjects that will begin sunitinib therapy will be on this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years
- Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
- Measurable disease that can be monitored per RECIST throughout the course of study participation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic function, as defined by the following criteria:
Key exclusion criteria (5 listed)
- Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
- Pregnancy or breastfeeding
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
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: ArcelisAutologous Dendritic Cell Immunotherapy | Drug | AGS-003 in combination with sunitinib |
Primary outcome
Tumor response
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
11 secondary outcomes
Clinical benefit (stable disease or response)
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Immune function
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Progression Free Survival (PFS)
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Overall Survival (OS)
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Treatment-emergent Adverse Events
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Physical Examinations
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Vital Signs
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor signs and symptoms indicating treatment-emergent autoimmunity
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Monitor for lymph node adenopathy
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Injection Site Reaction
Time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Lee F Allen, M.D., Ph.D. study director
Argos Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGS-003 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 1 site in United States.
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 22 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
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?
Tumor response (time frame: From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.). 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 27 Jun 2018.