Renal Cell Carcinoma
Conditions
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.
Interventions
BIOLOGICALHSPPC-96
Sponsors
Agenus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
The study consisted of Part 1 (Part 1a \[assessment of immune variation\] and Part 2a \[assay standardization\]) and Part 2 (immune monitoring). Due to Business reasons, the study did not advanced to the Part 2 portion. The results presented below are for Part 1 only. Per planned analysis, data were analyzed and collected combined for Part 1a and 1b.
Participants by arm
| Arm | Count |
|---|---|
| HSPPC-96 Vaccine Participants received 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 remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative study close | 2 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | HSPPC-96 Vaccine |
|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 11.48 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
The ELISPOT assay was not developed for this study and no immunogenicity data are available.
Time frame: 6-7 weeks post surgery up to Week 14
Population: No Participants Provided Immunology Data. No Participants Provided Immunology Data. The ELISPOT assay was not developed for this study, and no immunogenicity data were collected for analysis.