Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

Phase 2

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: HSPPC-96

• Registration Number: NCT01147536
• Lead Sponsor: Agenus Inc.

Brief Summary

The primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.

Detailed Description

The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation) and Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study). The study was terminated early with 12 participants enrolled only in Part 1a and Part 1b. Part 2 of the study involved randomization after 8 doses of HSSPC-96. After the 8 doses of HSSPC-96 administered in Part 2, the participants were to be randomized to the treatment extension arm or the placebo extension arm. There were no participants enrolled in Part 2 since the study was terminated early. Therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Disposition First Submitted: 2014-01-14
• Disposition First Submitted QC: 2014-02-12
• Disposition First Posted: 2014-03-13
• Results First Submitted: 2021-04-12
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Results First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of >= 25% clear cell carcinoma
• American joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence
• At least 8 doses of vaccine available from participant's tumor
• Life expectancy of at least 3 months
• Eastern cooperative oncology group performance status of 0 or 1
• Cardiovascular disease status of new york heart association class less than 2
• Adequate hematopoietic, renal and hepatic function
• Negative serology tests for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (anti-HCV-Ab)
• Females must have negative pregnancy test

Exclusion Criteria

• Evidence of metastatic or residual RCC
• Documented radiological enlarged lymph nodes
• Females who are pregnant or breastfeeding
• Use of any other investigational product from 4 weeks post-surgery
• Splenectomy performed during nephrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSPPC-96 Vaccine	HSPPC-96	Participants will receive up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses \[at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants will remain untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay	6-7 weeks post surgery up to Week 14	The ELISPOT assay was not developed for this study and no immunogenicity data are available.

Trial Locations

Locations (3)

Community Care Physicians; 🇺🇸 Albany, New York, United States

Pavillion de Recherche de Hotel Dieu; 🇨🇦 Quebec, Canada

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States