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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

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

Treatments: Biological: V935; Biological: V934-EP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753415

2008_541 (Other Identifier)

V934-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 10 patient groups

Part A: V935 LD

Experimental group

Description:

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

Treatment:

Biological: V935

Part A: V934 LD(3)+V935 LD

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

Biological: V935

Part A: V935 HD

Experimental group

Description:

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

Treatment:

Biological: V935

Part A: V934 HD(3)+V935 HD

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

Biological: V935

Part A: V934 HD(5)+V935 HD

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

Biological: V935

Part B: V935 LD/V934 Booster

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

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

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

Part B: V935 HD/V934 Booster

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

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

Experimental group

Description:

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.

Treatment:

Biological: V934-EP

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

Experimental group

Description:

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.

Treatment:

Biological: V934-EP