Status:
COMPLETED
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Non-Small Cell Lung Carcinoma
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 comb...
Eligibility Criteria
Inclusion
- Inclusion Criteria Part A
- Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage IIB or III melanoma; Stage II or III upper gastrointestinal tract carcinoma (e.g., esophagus, stomach, gallbladder, pancreas); Stage III colon carcinoma; Stage II, III, or IV (M0 only) renal cell carcinoma; Stage II, III, or IV (M0 only) bladder carcinoma; clinically-localized prostate carcinoma
- Participant has adequate organ function.
- Female participant of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment.
- Exclusion Criteria Part A
- Participant has known hypersensitivity to any component of study vaccine.
- Participant has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Participant must have no clinically significant electrocardiogram (ECG) abnormalities and not have a pacemaker or cardioverter/defibrillator implanted.
- Participant has undergone splenectomy or has any history of autoimmune disorder.
- Participant has received immunosuppressive treatment within 1 month prior to enrollment.
- Participant has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections.
- Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry.
- Participant is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination.
- Participant is known to be Human Immunodeficiency Virus (HIV)-seropositive.
- Participant has known history of Hepatitis B or C or active Hepatitis A.
- Participant has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination.
- The participant has been diagnosed with Systemic Lupus Erythematosus (SLE)
- Inclusion Criteria Part B
- Participant must have completed their respective vaccination Treatment Group regimen for Part A of this study.
- Participant must have completed a ≥12 week safety observation period prior to receiving their first V934-EP boost.
- Exclusion Criteria Part B
- Participant has new or metastatic tumor lesions since enrollment in Part A.
- Participant has developed any significant cardiac conditions since enrollment in Part A including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or NYHA Class III or IV congestive heart failure.
- Participant has undergone a splenectomy, or has developed any autoimmune disorders, since enrollment in Part A.
- Participant has received immunosuppressive treatment within 1 month prior to enrollment in Part B
- Participant has developed any acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections
- Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of entry to Part B.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00753415
Start Date
August 1 2008
End Date
April 1 2011
Last Update
March 17 2015
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