Clinical trial · Interventional
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512)
NCT02616185CI-TRIAL-00071028terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.
Summary
Brief summary (as posted)
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06753512 | Biological | — | UNRESOLVED |
| PF-06755990 | Biological | — | UNRESOLVED |
| PF-06755992 | Biological | — | UNRESOLVED |
| PF-06801591 | Biological | — | UNRESOLVED |
| TDS-IM Electroporation Device | Device | — | UNRESOLVED |
| Tremelimumab | Biological | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- PF-06753512
- interventionNames
- Biological: PF-06755992
- Biological: PF-06755990
- Device: TDS-IM Electroporation Device
- Biological: Tremelimumab
- Biological: PF-06801591
- Biological: PF-06753512
Primary outcomes (4)
- measure
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)
- description
- An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of prostate cancer * Adequate bone marrow, kidney and liver function * Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR * Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC) Exclusion Criteria: * ECOG performance status greater than or equal to 2 * Concurrent immunotherapy for prostate cancer * History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system. * History of inflammatory bowel disease. * Current use of any implanted electronic stimulation device * For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs * For post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
References
Publications (1)
- DERIVEDAutio KA, Higano CS, Nordquist L, Appleman LJ, Zhang T, Zhu XH, Babiker H, Vogelzang NJ, Prasad SM, Schweizer MT, Madan RA, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang IM, Zheng J, Tang SY, Hollingsworth R, Kern KA, Petrylak DP. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2023 Mar;11(3):e005702. doi: 10.1136/jitc-2022-005702. PMID 36948505