A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma

Trial Information

A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma

This is an international, open label, randomized Phase 3 trial in which patients with
surgically removable kidney cancer will be randomly selected post-operatively to receive
adjuvant treatment with HSPPC-96 or no adjuvant treatment. All patients will undergo
complete surgical removal of their tumors.

The primary objective of the study is to determine whether patients who receive adjuvant
autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal
cell carcinoma have improved recurrence-free survival as compared to patients who are not
receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance
of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial
will receive the vaccine once a week for 4 weeks, and then every other week until vaccine
depletion or disease recurrence. Both groups of patients will be followed regularly for
assessment of their disease status.

HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's
own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent
to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.