A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00753415
First received: September 15, 2008
Last updated: May 7, 2014
Last verified: May 2014
Results First Received: March 19, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-Small Cell Lung Carcinoma
Breast Cancer
Melanoma
Upper GI Tract Carcinoma
Colon Carcinoma
Renal Cell Carcinoma
Bladder Carcinoma
Prostate Cancer
Interventions: Biological: V935
Biological: V934-EP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.

Reporting Groups
  Description
Part A: V935 LD Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Part A: V934 LD(3)+V935 LD Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Part A: V935 HD Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
Part A: V934 HD(3)+V935 HD Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Part A: V934 HD(5)+V935 HD Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Part B: V935 LD/V934 Booster Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
Part B: V934 LD(3)+V935 LD/V934 Booster Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Part B: V935 HD/V934 Booster Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Part B: V934 HD(3)+V935 HD/V934 Booster Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Part B: V934 HD(5)+V934 HD/V934 Booster Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Participant Flow for 2 periods

Period 1:   Part A
    Part A: V935 LD     Part A: V934 LD(3)+V935 LD     Part A: V935 HD     Part A: V934 HD(3)+V935 HD     Part A: V934 HD(5)+V935 HD     Part B: V935 LD/V934 Booster     Part B: V934 LD(3)+V935 LD/V934 Booster     Part B: V935 HD/V934 Booster     Part B: V934 HD(3)+V935 HD/V934 Booster     Part B: V934 HD(5)+V934 HD/V934 Booster  
STARTED     3     3     10     11     10     0     0     0     0     0  
COMPLETED     2     3     8     9     10     0     0     0     0     0  
NOT COMPLETED     1     0     2     2     0     0     0     0     0     0  
Disease progression                 1                 0                 1                 2                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0  

Period 2:   Part B
    Part A: V935 LD     Part A: V934 LD(3)+V935 LD     Part A: V935 HD     Part A: V934 HD(3)+V935 HD     Part A: V934 HD(5)+V935 HD     Part B: V935 LD/V934 Booster     Part B: V934 LD(3)+V935 LD/V934 Booster     Part B: V935 HD/V934 Booster     Part B: V934 HD(3)+V935 HD/V934 Booster     Part B: V934 HD(5)+V934 HD/V934 Booster  
STARTED     0     0     0     0     0     1 [1]   2 [2]   7 [3]   9 [4]   9 [5]
COMPLETED     0     0     0     0     0     1     2     6     6     8  
NOT COMPLETED     0     0     0     0     0     0     0     1     3     1  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 1                 1                 0  
Disease progression                 0                 0                 0                 0                 0                 0                 0                 0                 2                 1  
[1] Of 2 eligible participants who completed Part A, 1 chose to enter Part B
[2] Of 3 eligible participants who completed Part A, 2 chose to enter Part B
[3] Of 8 eligible participants who completed Part A, 7 chose to enter Part B
[4] 9 participants who completed Part A were eligible and enrolled in Part B
[5] Of 10 eligible participants who completed Part A, 9 chose to enter Part B



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Part A: V935 LD Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Part A: V934 LD(3)+V935 LD Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Part A: V935 HD Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Part A: V934 HD(3)+V935 HD Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Part A: V934 HD(5)+V935 HD Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Total Total of all reporting groups

Baseline Measures
    Part A: V935 LD     Part A: V934 LD(3)+V935 LD     Part A: V935 HD     Part A: V934 HD(3)+V935 HD     Part A: V934 HD(5)+V935 HD     Total  
Number of Participants  
[units: participants]
  3     3     10     11     10     37  
Age  
[units: Years]
Mean ± Standard Deviation
  70.0  ± 9.5     70.0  ± 6.2     63.8  ± 10.0     58.8  ± 11.7     60.2  ± 11.7     62.4  ± 11.0  
Gender  
[units: Participants]
           
Female     0     1     4     4     1     10  
Male     3     2     6     7     9     27  



  Outcome Measures
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1.  Primary:   Number of Participants With Dose-Limiting Toxicity (DLT)   [ Time Frame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period ]

2.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period ]

3.  Secondary:   Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)   [ Time Frame: From pre-vaccination to Week 69 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: 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
Results First Received: March 19, 2014
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration