Clinical trial NCT00753415: A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Official title: A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Carcinoma
Breast Cancer
Melanoma
Upper GI Tract Carcinoma
Colon Carcinoma
Renal Cell Carcinoma
Bladder Carcinoma
Prostate Cancer
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
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicity (DLT)
timeFrame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Secondary outcomes:
measure: Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
timeFrame: From pre-vaccination to Week 69
Other outcomes:
Locations:
Study officials:
References:
citation: Aurisicchio L, Fridman A, Mauro D, Sheloditna R, Chiappori A, Bagchi A, Ciliberto G. Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study. J Transl Med. 2020 Jan 30;18(1):39. doi: 10.1186/s12967-020-02228-9.