At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
V935 +1 morebiological
Likely dose
V935 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors
In Brief
A Phase 1 clinical trial evaluating V935 and V934-EP for Non-Small Cell Lung Carcinoma and 7 related conditions. Completed, enrolled 37 participants.
Detailed Summary
This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Carcinoma, Breast Cancer, Melanoma, Upper GI Tract Carcinoma, Colon Carcinoma, Renal Cell Carcinoma, Bladder Carcinoma, Prostate Cancer
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionApr 2011
TodayJul 2026
First PostedSep 16, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.8 years ago
Interventions
V935biological
A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL).
V934-EPbiological
A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).