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Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer

Sponsored by Argos Therapeutics

About this trial

Last updated 12 years ago

Study ID

AGS-003-004

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 13 years ago

What is this trial about?

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer

What are the participation requirements?

Yes

Inclusion Criteria

- Have a new diagnosis of metastatic renal cell carcinoma;

- Measurable disease

- Must be at least 18 years or older;

- Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy

- ECOG of 0 or 1;

- Free of brain metastases by CT or MRI;

- Normal renal function in contralateral kidney;

- Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;

- Clinically acceptable screening results.

- No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;

- No active autoimmune disease

Locations

Location

Status