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
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Argos Therapeutics
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Tumor response
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-
- •Measurable disease that can be monitored per RECIST throughout the course of study participation.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •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:
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.
Arms & Interventions
AGS-003 in combination with sunitinib
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: AGS-003 (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Immune function(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Overall Survival (OS)(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(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Monitor for lymph node adenopathy(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Injection Site Reaction(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Clinical benefit (stable disease or response)(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Progression Free Survival (PFS)(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Treatment-emergent Adverse Events(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(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Physical Examinations(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)
- Vital Signs(From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.)