Phase 1
Completed N=37
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Source: ClinicalTrials.gov NCT00753415 ↗Enrolled (actual)
37
Serious AEs
9.2%
Results posted
Jun 2014
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicity (DLT) — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
3; 3; 8; 11; 10; 1 | — |
| SECONDARY Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate) |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00753415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.