Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

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.

AGS-003

Lee F Allen, M.D., Ph.D.

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

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.

A Rollover Protocol for Subjects Previously Treated With AGS-003

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

Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).

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

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.

Evaluate PFS from the date of registration until PFS is reached per RECIST

Evaluate OS from date of registration until date of death.

Monitor incidence of treatment-emergent Adverse Events.

Clinical laboratory values will be monitored for changes from baseline.

Monitor changes from baseline in physical examinations

Monitor changes from baseline in vital signs

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.

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.

Monitor changes from baseline in injection site reactions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Rollover Protocol for Subjects Previously Treated With AGS-003	NCT01482949	Renal Cell Carc...	AGS-003	18 Years -	Argos Therapeutics
A Rollover Protocol for Subjects Previously Treated With AGS-003	NCT01482949	Renal Cell Carc...	AGS-003	18 Years -	Argos Therapeutics

Spots Global Cancer Trial Database for arcelis

Every month we try and update this database with for arcelis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for arcelis

Every month we try and update this database with for arcelis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for arcelis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.