A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Basic Trial Information
|Phase I||Treatment||Completed||18 and over||Pharmaceutical / Industry||V934-002|
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.
Further Study Information
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.
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.
Trial Contact Information
Trial Lead Organizations/Sponsors
Merck and Company, Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00753415
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.