Clinical trial · Interventional
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage) for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's business decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSPPC-96 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSPPC-96 Vaccine
- description
- 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.
- interventionNames
- Biological: HSPPC-96
Primary outcomes (1)
- measure
- Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
- timeFrame
- 6-7 weeks post surgery up to Week 14
- description
- The ELISPOT assay was not developed for this study and no immunogenicity data are available.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available