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
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
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
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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Emory University||Atlanta, Georgia 30322|
|Blumenthal Cancer Center/Carolinas Medical Center||Charlotte, North Carolina 28203|
|The Indiana University Cancer Center||Indianapolis, Indiana 46202|
|Urology of Virginia - Sentara Medical Group||Norfolk, Virginia 23502|