A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Condition: Non-Small Cell Lung Carcinoma; Breast Cancer; Melanoma; Upper GI Tract Carcinoma; Colon Carcinoma; Renal Cell Carcinoma; Bladder Carcinoma; Prostate Cancer
MeSH terms: Carcinoma; Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Urinary Bladder Neoplasms
Intervention: V935; V934-EP
Intervention description: A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10^9 vector genomes/mL) or a HD (1 x 10^11 vector genomes/mL).; A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

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.