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A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

NCT02616185

Description:

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: B7791001
  • SECONDARY ID: PRCA VBIR FIP STUDY
  • NCT ID: NCT02616185

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
PF-06755992Dose Escalation
PF-06755990Dose Escalation
TremelimumabPF-06753388Dose Escalation
SunitinibDose Escalation
PF-06801591Dose Escalation

Purpose

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimental
  • Sunitinib

Eligibility Criteria

        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

          -  Progressive disease post-surgical castration or during androgen suppression therapy
             (pre-secondary hormone CRPC) OR

          -  Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with
             documented progressive disease (post-secondary hormone CRPC)

        Exclusion Criteria:

          -  Cancer-related pain requiring scheduled opioid narcotics for control

          -  ECOG performance status greater than or equal to 2

          -  Concurrent immunotherapy for prostate cancer

          -  History of or active autoimmune disorders or history of inflammatory bowel disorders

          -  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 pre-secondary hormone patients, no prior or concurrent treatment with a secondary
             hormone (e.g. enzalutamide, abiraterone) and no metastasis to organ systems other
             than lymph nodes and/or bone

          -  For post-secondary hormone patients, no concurrent treatment with a secondary hormone
             (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and grade of treatment-emergent adverse events including DLTs
Time Frame:Baseline up to Day 29
Safety Issue:
Description:DLTs in order to determine the maximum tolerated dose

Secondary Outcome Measures

Measure:Immune response to the selected prostate cancer tumor-antigens
Time Frame:Baseline up to Cycle 1 Day 85 and then every 29 and 99 days thereafter up to 3 years
Safety Issue:
Description:
Measure:Antibody response specific to the PSMA antigen
Time Frame:Baseline up to Cycle 1 Day 85 and then every 29 and 99 days thereafter up to 3 years
Safety Issue:
Description:
Measure:Maximum observed plasma concentration of tremelimumab (Cmax)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Time to maximum concentration of tremelimumab (Tmax)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Area under the curve from time zero extrapolated to infinity of tremelimumab
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Trough concentrations after multiple doses of tremelimumab (Ctrough)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Incidence and titers of anti-drug antibodies against tremelimumab
Time Frame:From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter up to 3 years
Safety Issue:
Description:
Measure:Maximum observed plasma concentration of sunitinib (Cmax)
Time Frame:Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years
Safety Issue:
Description:
Measure:Time to maximum concentration of sunitinib (Tmax)
Time Frame:Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years
Safety Issue:
Description:
Measure:Steady state area under the curve during one dose interval of sunitinib (AUCtau)
Time Frame:Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years
Safety Issue:
Description:
Measure:Incidence and titers of neutralizing antibodies against PF-06801591
Time Frame:From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter up to 3 years
Safety Issue:
Description:
Measure:Maximum observed plasma concentration of PF-06801591 (Cmax)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Time to maximum concentration of PF-06801591 (Tmax)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Area under the curve from time zero extrapolated to infinity of PF-06801591
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:
Measure:Trough concentrations after multiple doses of PF-06801591 (Ctrough)
Time Frame:Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Last Updated

March 27, 2017