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Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

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

NCT00033904•Agenus Inc.

View on ClinicalTrials.gov

Summary

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Detailed Description

Primary Objective: * The primary objective of this study is to determine whether subjects randomized to receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell carcinoma at high risk of recurrence, have improved recurrence-free survival as compared to subjects with no adjuvant treatment. Secondary Objective: * Determine whether subjects randomized to receive HSPPC-96 have improved survival as compared to subjects with no adjuvant treatment. * Further characterize the safety profile of HSPPC-96.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent;
•Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluation
•Performance status (Zubrod / ECOG-WHO scale)less than or equal to 1 and life expectancy of greater than three months, within 2 weeks of surgery.
•Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of surgery.
•Signed written informed consent.

Exclusion Criteria

•Prior chemo-, hormonal, immuno- or radiotherapy for renal cell cancer;
•History of primary or secondary immunodeficiency, or patients using immunosuppressive drugs, e.g. systemic corticosteroids, cyclosporin A;
•Current malignancies at other sites or previous other cancer within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
•Embolization of the renal artery prior to nephrectomy;
•Known distant metastases;
•Active, uncontrolled infection or other serious medical illnesses.
•Eligibility Assessment:
•(between 2 weeks pre- and 4 weeks post-surgery)
•Prior to randomization and entry into the tumor evaluation phase, all subjects must undergo testing to confirm that they are free of distant metastatic disease, and that they meet all other criteria.
•Eligibility Criteria which must be assessed and confirmed prior to randomization:
+9 more criteria

Locations (76)

Anchorage, Alaska, United States

Tucson, Arizona, United States

Los Angeles, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Farmington, Connecticut, United States

Boca Raton, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Key Dates

Start Date

June 1, 2000

Primary Completion Date

April 1, 2007

Completion Date

April 1, 2007

Last Updated

September 7, 2012

Enrollment

650

Estimated participants

Conditions

Renal Cell Carcinoma

Interventions

autologous human tumor-derived HSPPC-96

DRUG

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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RECRUITINGNA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

NCT06391099

Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma