Trials / Completed
CompletedNCT00753415
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.
Conditions
- Non-Small Cell Lung Carcinoma
- Breast Cancer
- Melanoma
- Upper GI Tract Carcinoma
- Colon Carcinoma
- Renal Cell Carcinoma
- Bladder Carcinoma
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V935 | 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). |
| BIOLOGICAL | V934-EP | 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). |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2008-09-16
- Last updated
- 2015-03-17
- Results posted
- 2014-06-03
Source: ClinicalTrials.gov record NCT00753415. Inclusion in this directory is not an endorsement.