Urinary Tract, Sexual Organs, and Pregnancy Conditions

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All Drugs and Chemicals

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Vaccines

Cola

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

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.

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

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.

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.

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.

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.

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).

V935

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).

V934-EP

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.

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.

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

A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.

This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.

An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.

Merck Sharp & Dohme LLC

Participants who completed Part A had the option to enter Part B.

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

Part A: V935 LD

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

Part A: V934 LD(3)+V935 LD

Part A: V935 HD

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

Part A: V934 HD(3)+V935 HD

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

Part A: V934 HD(5)+V935 HD

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

Part B: V935 LD/V934 Booster

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

Part B: V935 HD/V934 Booster

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

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

Total

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.

Number of Participants With Dose-Limiting Toxicity (DLT)

All Participants as Treated (APaT) population; all participants who received at least one vaccination.

Number of Participants With Adverse Events (AEs)

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

Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.

Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)

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

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

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

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

Spots Global Cancer Trial Database for upper gi tract carcinoma