A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

NCT ID: NCT00753415

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-04-30

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.

Conditions

Non-Small Cell Lung Carcinoma; Breast Cancer; Melanoma; Upper GI Tract Carcinoma; Colon Carcinoma; Renal Cell Carcinoma; Bladder Carcinoma; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: V935 LD

Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Group Type: EXPERIMENTAL

V935

Intervention Type: BIOLOGICAL

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).

Part A: V934 LD(3)+V935 LD

Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.

Group Type: EXPERIMENTAL

V935

Intervention Type: BIOLOGICAL

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).

V934-EP

Intervention Type: BIOLOGICAL

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).

Part A: V935 HD

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

Group Type: EXPERIMENTAL

V935

Intervention Type: BIOLOGICAL

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).

Part A: V934 HD(3)+V935 HD

Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Group Type: EXPERIMENTAL

V935

Intervention Type: BIOLOGICAL

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).

V934-EP

Intervention Type: BIOLOGICAL

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).

Part A: V934 HD(5)+V935 HD

Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Group Type: EXPERIMENTAL

V935

Intervention Type: BIOLOGICAL

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).

V934-EP

Intervention Type: BIOLOGICAL

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).

Part B: V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Group Type: EXPERIMENTAL

V934-EP

Intervention Type: BIOLOGICAL

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).

Part B: V934 LD(3)+V935 LD/V934 Booster

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

Group Type: EXPERIMENTAL

V934-EP

Intervention Type: BIOLOGICAL

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).

Part B: V935 HD/V934 Booster

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

Group Type: EXPERIMENTAL

V934-EP

Intervention Type: BIOLOGICAL

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).

Part B: V934 HD(3)+V935 HD/V934 Booster

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

Group Type: EXPERIMENTAL

V934-EP

Intervention Type: BIOLOGICAL

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).

Part B: V934 HD(5)+V935 HD/V934 Booster

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

Group Type: EXPERIMENTAL

V934-EP

Intervention Type: BIOLOGICAL

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).

Interventions

V935

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).

Intervention Type: BIOLOGICAL

V934-EP

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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)

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 32000810 (View on PubMed)

Other Identifiers

2008_541

Identifier Type: OTHER

Identifier Source: secondary_id

V934-002

Identifier Type: -

Identifier Source: org_study_id