A Phase 1 interventional study of V935 and V934-EP in Non-Small Cell Lung Carcinoma, Breast Cancer and Melanoma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 37 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Inclusion Criteria Part A
Exclusion Criteria Part A
Inclusion Criteria Part B
Exclusion Criteria Part B
Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Biological: V935
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.
Biological: V935 · Biological: V934-EP
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Biological: V935
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.
Biological: V935 · Biological: V934-EP
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.
Biological: V935 · Biological: V934-EP
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.
Biological: V934-EP
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.
Biological: V934-EP
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.
Biological: V934-EP
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.
Biological: V934-EP
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.
Biological: V934-EP
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).
Number of Participants With Dose-Limiting Toxicity (DLT)
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.
Time frame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Number of Participants With Adverse Events (AEs)
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.
Time frame: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
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.
Time frame: From pre-vaccination to Week 69
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.
| Milestone | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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)+V934 HD/V934 Booster |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 10 | 11 | 10 | 0 | 0 | 0 | 0 | 0 |
| Completed | 2 | 3 | 8 | 9 | 10 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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)+V934 HD/V934 Booster |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 7 | 9 | 9 |
| Completed | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 6 | 6 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Disease progression | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
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.
| Participants | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 3 | 3 | 8 | 11 | 10 | 1 | 1 | 3 | 8 | 7 |
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.
No measurements were reported for this outcome.
Collected over SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: V935 LD | — | 1/3 (33.3%) | 3/3 (100%) |
| Part A: V934 LD(3)+V935 LD | — | 0/3 (0%) | 3/3 (100%) |
| Part A: V935 HD | — | 2/10 (20%) | 8/10 (80%) |
| Part A: V934 HD(3)+V935 HD | — | 2/11 (18.2%) | 11/11 (100%) |
| Part A: V934 HD(5)+V935 HD | — | 1/10 (10%) | 10/10 (100%) |
| Part B: V935 LD/V934 Booster | — | 0/1 (0%) | 1/1 (100%) |
| Part B: V934 LD(3)+V935 LD/V934 Booster | — | 0/2 (0%) | 1/2 (50%) |
| Part B: V935 HD/V934 Booster | — | 0/7 (0%) | 3/7 (42.9%) |
| Part B: V934 HD(3)+V935 HD/V934 Booster | — | 0/9 (0%) | 8/9 (88.9%) |
| Part B: V934 HD(5)+V935 HD/V934 Booster | — | 0/9 (0%) | 7/9 (77.8%) |
| Event | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Coronary artery stenosisCardiac disorders | 1/3 | 0/3 | 0/10 | 0/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| PneumoniaInfections and infestations | 1/3 | 0/3 | 0/10 | 0/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| CellulitisInfections and infestations | 0/3 | 0/3 | 0/10 | 0/11 | 1/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Haematocrit decreasedInvestigations | 0/3 | 0/3 | 1/10 | 0/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/3 | 1/10 | 0/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Depressed moodPsychiatric disorders | 0/3 | 0/3 | 0/10 | 0/11 | 1/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Pericardial effusionCardiac disorders | 0/3 | 0/3 | 0/10 | 1/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/3 | 0/3 | 0/10 | 1/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Lobar pneumoniaInfections and infestations | 0/3 | 0/3 | 0/10 | 1/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Event | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 0/3 | 1/3 | 0/10 | 8/11 | 9/10 | 1/1 | 1/2 | 3/7 | 5/9 | 7/9 |
| Injection site erythemaGeneral disorders | 0/3 | 2/3 | 0/10 | 8/11 | 6/10 | 0/1 | 0/2 | 1/7 | 6/9 | 3/9 |
| Injection site swellingGeneral disorders | 0/3 | 0/3 | 0/10 | 8/11 | 6/10 | 0/1 | 0/2 | 2/7 | 4/9 | 2/9 |
| FatigueGeneral disorders | 0/3 | 0/3 | 0/10 | 5/11 | 6/10 | 0/1 | 0/2 | 0/7 | 2/9 | 1/9 |
| NasopharyngitisInfections and infestations | 0/3 | 0/3 | 0/10 | 1/11 | 4/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Chest discomfortGeneral disorders | 0/3 | 1/3 | 0/10 | 0/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Injection site reactionGeneral disorders | 0/3 | 1/3 | 0/10 | 1/11 | 1/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Oedema peripheralGeneral disorders | 0/3 | 1/3 | 0/10 | 1/11 | 0/10 | 0/1 | 0/2 | 0/7 | 0/9 | 0/9 |
| Upper respiratory tract infectionInfections and infestations | 0/3 | 1/3 | 0/10 | 1/11 | 1/10 | 0/1 | 0/2 | 0/7 | 1/9 | 0/9 |
| DizzinessNervous system disorders | 1/3 | 0/3 | 0/10 | 1/11 | 1/10 | 0/1 | 0/2 | 0/7 | 0/9 | 1/9 |
| Age, Continuous(Years) | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | Total |
|---|---|---|---|---|---|---|
| Mean | 70.0 ± 9.5 | 70.0 ± 6.2 | 63.8 ± 10.0 | 58.8 ± 11.7 | 60.2 ± 11.7 | 62.4 ± 11.0 |
| Sex: Female, Male(Participants) | Part A: V935 LD | Part A: V934 LD(3)+V935 LD | Part A: V935 HD | Part A: V934 HD(3)+V935 HD | Part A: V934 HD(5)+V935 HD | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 1 | 4 | 4 | 1 | 10 |
| Male | 3 | 2 | 6 | 7 | 9 | 27 |
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Merck Sharp & Dohme LLC