Back to resultsA Rollover Protocol for Subjects Previously Treated With AGS-003
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGS-003
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring RCC, Kidney Cancer, Renal Cancer, Arcelis
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- University of Minnesota Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AGS-003 in combination with sunitinib
Arm Description
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.
Outcomes
Primary Outcome Measures
Tumor response
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
Secondary Outcome Measures
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
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.
Progression Free Survival (PFS)
Evaluate PFS from the date of registration until PFS is reached per RECIST
Overall Survival (OS)
Evaluate OS from date of registration until date of death.
Treatment-emergent Adverse Events
Monitor incidence of treatment-emergent Adverse Events.
Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline
Clinical laboratory values will be monitored for changes from baseline.
Physical Examinations
Monitor changes from baseline in physical examinations
Vital Signs
Monitor changes from baseline in vital signs
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.
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.
Injection Site Reaction
Monitor changes from baseline in injection site reactions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01482949
Brief Title
A Rollover Protocol for Subjects Previously Treated With AGS-003
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Argos Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
RCC, Kidney Cancer, Renal Cancer, Arcelis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGS-003 in combination with sunitinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AGS-003
Other Intervention Name(s)
Arcelis
Intervention Description
Autologous Dendritic Cell Immunotherapy
Primary Outcome Measure Information:
Title
Tumor response
Description
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Secondary Outcome Measure Information:
Title
Clinical benefit (stable disease or response)
Description
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
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Immune function
Description
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.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Progression Free Survival (PFS)
Description
Evaluate PFS from the date of registration until PFS is reached per RECIST
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Overall Survival (OS)
Description
Evaluate OS from date of registration until date of death.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Treatment-emergent Adverse Events
Description
Monitor incidence of 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.
Title
Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline
Description
Clinical laboratory values will be monitored for changes from baseline.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Physical Examinations
Description
Monitor changes from baseline in physical examinations
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Vital Signs
Description
Monitor changes from baseline in vital signs
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Monitor signs and symptoms indicating treatment-emergent autoimmunity
Description
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.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Monitor for lymph node adenopathy
Description
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.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
Title
Injection Site Reaction
Description
Monitor changes from baseline in injection site reactions.
Time Frame
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee F Allen, M.D., Ph.D.
Organizational Affiliation
Argos Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Rollover Protocol for Subjects Previously Treated With AGS-003
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