TriangleNCT00753415 · STUDY IN CONTEXT
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- trial label
- A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 3
- harms Count
- 10
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- source section id
- NCT00753415-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose-Limiting Toxicity (DLT)
- endpoint definition
- 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 origin
- Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0001
- source section id
- NCT00753415-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Adverse Events (AEs)
- endpoint definition
- 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 origin
- Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All Participants as Treated (APaT) population; all participants who received at least one vaccination.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0002
- source section id
- NCT00753415-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
- endpoint definition
- 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 origin
- From pre-vaccination to Week 69
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A: V935 LD
- regimen
- Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A: V934 LD(3)+V935 LD
- regimen
- 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.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part A: V935 HD
- regimen
- Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part A: V934 HD(3)+V935 HD
- regimen
- 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.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part A: V934 HD(5)+V935 HD
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part B: V935 LD/V934 Booster
- regimen
- 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.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part B: V934 LD(3)+V935 LD/V934 Booster
- regimen
- 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.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part B: V935 HD/V934 Booster
- regimen
- 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.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part B: V934 HD(3)+V935 HD/V934 Booster
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Part B: V934 HD(5)+V935 HD/V934 Booster
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part A: V935 LD
- regimen
- Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part A: V934 LD(3)+V935 LD
- regimen
- 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.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753415-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG000
- source section id
- NCT00753415-ae
- event group key
- EG000
- event group label
- Part A: V935 LD
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG001
- source section id
- NCT00753415-ae
- event group key
- EG001
- event group label
- Part A: V934 LD(3)+V935 LD
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG002
- source section id
- NCT00753415-ae
- event group key
- EG002
- event group label
- Part A: V935 HD
- serious affected
- 2
- serious at risk
- 10
- other affected
- 8
- other at risk
- 10
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG003
- source section id
- NCT00753415-ae
- event group key
- EG003
- event group label
- Part A: V934 HD(3)+V935 HD
- serious affected
- 2
- serious at risk
- 11
- other affected
- 11
- other at risk
- 11
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG004
- source section id
- NCT00753415-ae
- event group key
- EG004
- event group label
- Part A: V934 HD(5)+V935 HD
- serious affected
- 1
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG005
- source section id
- NCT00753415-ae
- event group key
- EG005
- event group label
- Part B: V935 LD/V934 Booster
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG006
- source section id
- NCT00753415-ae
- event group key
- EG006
- event group label
- Part B: V934 LD(3)+V935 LD/V934 Booster
- serious affected
- 0
- serious at risk
- 2
- other affected
- 1
- other at risk
- 2
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG007
- source section id
- NCT00753415-ae
- event group key
- EG007
- event group label
- Part B: V935 HD/V934 Booster
- serious affected
- 0
- serious at risk
- 7
- other affected
- 3
- other at risk
- 7
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG008
- source section id
- NCT00753415-ae
- event group key
- EG008
- event group label
- Part B: V934 HD(3)+V935 HD/V934 Booster
- serious affected
- 0
- serious at risk
- 9
- other affected
- 8
- other at risk
- 9
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00753415
- harm key
- EG009
- source section id
- NCT00753415-ae
- event group key
- EG009
- event group label
- Part B: V934 HD(5)+V935 HD/V934 Booster
- serious affected
- 0
- serious at risk
- 9
- other affected
- 7
- other at risk
- 9
- frequency threshold
- 5
- collection period
- 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
- event definition
- Participants who completed Part A had the option to enter Part B.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice