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


The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

Trial Description

Primary Outcome:

  • Tumour response
Secondary Outcome:
  • Clinical benefit (stable disease or response)
  • Immune function
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Treatment-emergent Adverse Events
  • Monitor clinical chemistry, hematology, and urinalysis for treatment-emergent changes from baseline
  • Physical Examinations
  • Vital Signs
  • Monitor signs and symptoms indicating treatment-emergent autoimmunity
  • Monitor for lymph node adenopathy
  • Injection Site Reaction
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 tumour 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.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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