A Phase 3 interventional study of HSPPC-96 in Kidney Cancer and Renal Cell Carcinoma, sponsored by Agenus Inc.. Terminated at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-07.
Sponsored by Agenus Inc. · Phase 3, Interventional, and Treatment
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 autologous HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.
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.
973 studies on the registry are indexed under Kidney Neoplasms; 214 are open to participants now.
This study's enrollment of 600 is above the median of 43 across 664 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Agenus Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.
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This does not represent the full set of inclusion/exclusion criteria
Inclusion Criteria:
Exclusion Criteria:
To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)
To determine whether patients randomized to receive adjuvant HSPPC-96 have improved overall survival as compared to patients in the observation group (without adjuvant treatment)
To further characterize the safety profile of HSPPC-96
This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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