Clinical trial · Interventional
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
NCT00753415CI-TRIAL-00017147completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Upper GI Tract Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| V934-EP | Biological | — | UNRESOLVED |
| V935 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Part A: V935 LD
- description
- Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
- interventionNames
- Biological: V935
- type
- EXPERIMENTAL
- label
- Part A: V934 LD(3)+V935 LD
- 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.
- interventionNames
- Biological: V935
- Biological: V934-EP
- type
- EXPERIMENTAL
- label
- Part A: V935 HD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAurisicchio 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. PMID 32000810