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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00753415 |
Purpose
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. In Part A, participants will be assigned to get V935 vaccine alone or V934 and V935 vaccine. Part B is an optional part of the study, offering V934 vaccine boosts to participants who were enrolled in Part A.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Carcinoma Breast Cancer Melanoma Upper GI Tract Carcinoma Colon Carcinoma Renal Cell Carcinoma Bladder Carcinoma Prostate Cancer |
Biological: V935 Biological: V934 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors |
| Enrollment: | 37 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A - Arm 1 V935 |
Biological: V935
A low-dose cohort will be enrolled first, then a high-dose cohort. V935 will be administered in 0.5 mL doses intramuscularly (IM) every 2 weeks for 2 doses followed by a 4-week observation period. In Part A, Arm 1, only V935 will be administered. In Part A, Arms 2 and 3, the two V935 doses will be administered after the 4 week observation period following the V934 doses.
|
| Experimental: Part A - Arm 2 V934-EP (3 doses) + V935 |
Biological: V935
A low-dose cohort will be enrolled first, then a high-dose cohort. V935 will be administered in 0.5 mL doses intramuscularly (IM) every 2 weeks for 2 doses followed by a 4-week observation period. In Part A, Arm 1, only V935 will be administered. In Part A, Arms 2 and 3, the two V935 doses will be administered after the 4 week observation period following the V934 doses.
Biological: V934
The low-dose cohort will be enrolled first, then the high-dose cohort will be enrolled. Low-dose V934 will be administered in 0.5 mL doses IM followed by electroportation (EP) every 2 weeks for 3 doses, followed by a 4 week observation period. High-dose V934 will be administered 0.5 mL doses IM followed by EP every 2 weeks for 5 doses, followed by a 4 week observation period. V934 will be administered prior to V935 in Arms 2 and 3. In the optional V934 boost phase, V934 only will be administered in 0.5 mL doses IM every 2 weeks for 3 doses.
|
| Experimental: Part A - Arm 3 V934-EP (5 doses) + V935 |
Biological: V935
A low-dose cohort will be enrolled first, then a high-dose cohort. V935 will be administered in 0.5 mL doses intramuscularly (IM) every 2 weeks for 2 doses followed by a 4-week observation period. In Part A, Arm 1, only V935 will be administered. In Part A, Arms 2 and 3, the two V935 doses will be administered after the 4 week observation period following the V934 doses.
Biological: V934
The low-dose cohort will be enrolled first, then the high-dose cohort will be enrolled. Low-dose V934 will be administered in 0.5 mL doses IM followed by electroportation (EP) every 2 weeks for 3 doses, followed by a 4 week observation period. High-dose V934 will be administered 0.5 mL doses IM followed by EP every 2 weeks for 5 doses, followed by a 4 week observation period. V934 will be administered prior to V935 in Arms 2 and 3. In the optional V934 boost phase, V934 only will be administered in 0.5 mL doses IM every 2 weeks for 3 doses.
|
| Experimental: Part B - V934 Vaccine Boost Phase |
Biological: V934
The low-dose cohort will be enrolled first, then the high-dose cohort will be enrolled. Low-dose V934 will be administered in 0.5 mL doses IM followed by electroportation (EP) every 2 weeks for 3 doses, followed by a 4 week observation period. High-dose V934 will be administered 0.5 mL doses IM followed by EP every 2 weeks for 5 doses, followed by a 4 week observation period. V934 will be administered prior to V935 in Arms 2 and 3. In the optional V934 boost phase, V934 only will be administered in 0.5 mL doses IM every 2 weeks for 3 doses.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria Part A
Exclusion Criteria Part A
Inclusion criteria Part B
Exclusion criteria Part B
Contacts and Locations
More Information
| Responsible Party: | Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00753415 History of Changes |
| Other Study ID Numbers: | V934-002, 2008_541 |
| Study First Received: | September 15, 2008 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Urinary Bladder Neoplasms Breast Neoplasms Renal Cell carcinoma Melanoma Prostatic Neoplasms Colonic Neoplasms Urologic Neoplasms Urogenital Neoplasms Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Neoplasms Glandular and Epithelial Neoplasms by Histologic Type |
Adenocarcinoma Kidney Neoplasms Kidney Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Genital Neoplasms Male Genital Diseases Male, Prostatic Diseases Colorectal Neoplasms Intestinal Neoplasms |
|
Urinary Bladder Neoplasms Breast Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Lung Neoplasms Melanoma Prostatic Neoplasms Colonic Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenocarcinoma Kidney Neoplasms Kidney Diseases Neuroendocrine Tumors Neuroectodermal Tumors |