Ignite Creation Date:
2025-12-18 @ 9:48 AM
Ignite Modification Date:
2025-12-23 @ 11:09 PM
Study NCT ID:
NCT01784913
Status:
None
Last Update Posted:
2024-12-16 00:00:00
First Post:
2013-01-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase I/IIA Study of UV1 Vaccination in Patients With Hormone-sensitive Metastatic Prostate Cancer
Status:
None
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UV1/hTERT2012P
Brief Summary:
The study is an open labeled dose-escalating phase I/IIa study of UV1 peptide vaccination in patients with androgen-sensitive metastatic prostate cancer. Patients will be prospectively enrolled in this study if diagnosis of adenocarcinoma only has been histologically confirmed and they are eligible for (or have already started up to 6 months prior to inclusion) standard GnRH-agonist first line androgen deprivation therapy (ADT) combined with anti-androgen to achieve complete androgen blockade (CAB). UV1 vaccinations will be applied simultaneously with CAB.
When indicated, patients may receive concomitant radiotherapy.
The following 2-step design will be used:
1. Conventional dose escalation with at least 3 patients per dose level (3 selected dose levels).
2. Expansion of each dose level to a total of 7 patients for assessment of immune response levels
13 UV1 vaccinations will be given during the first 6 months (week 26) of treatment, unless clinical deterioration or unacceptable toxicity is encountered. GM-CSF (Leukine ®) will be administered locally 10-15 minutes before each UV1 vaccination.
Hormone naïve patients will receive standard complete androgen blockade by GnRH-agonist (3 months depot formulation sc.) and bicalutamide 50 mg orally per day (CAB). Patients already on GnRH-agonist therapy will continue with their initial treatment with addition of bicalutamide 50 mg orally per day.
When indicated, patients may receive concomitant radiotherapy.
The following 2-step design will be used:
1. Conventional dose escalation with at least 3 patients per dose level (3 selected dose levels).
2. Expansion of each dose level to a total of 7 patients for assessment of immune response levels
13 UV1 vaccinations will be given during the first 6 months (week 26) of treatment, unless clinical deterioration or unacceptable toxicity is encountered. GM-CSF (Leukine ®) will be administered locally 10-15 minutes before each UV1 vaccination.
Hormone naïve patients will receive standard complete androgen blockade by GnRH-agonist (3 months depot formulation sc.) and bicalutamide 50 mg orally per day (CAB). Patients already on GnRH-agonist therapy will continue with their initial treatment with addition of bicalutamide 50 mg orally per day.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: