Clinical Trials /

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:

Completed

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-06755992AdC68Dose Escalation
PF-06755990pDNADose Escalation
TremelimumabPF-06753388Dose Escalation
PF-06801591Dose Escalation
PF-06753512VBIR-1 or PrCa VBIRDose 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 EscalationExperimentalPF-06753512
  • PF-06755992
  • PF-06755990
  • Tremelimumab
  • PF-06801591
  • PF-06753512

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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part A. Incidence and grade of treatment-emergent adverse events including DLTs
Time Frame:Baseline for up to 3 years
Safety Issue:
Description:DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period

Secondary Outcome Measures

Measure:Immune response to the selected prostate cancer tumor-antigens
Time Frame:Baseline up to Cycle 1 Day 85; Day 1, Day 29 and Day 99 of Cycle 2; every 6 months 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; Day 1 and Day 99 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Maximum observed plasma concentration of tremelimumab (Cmax)
Time Frame:Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Time to maximum concentration of tremelimumab (Tmax)
Time Frame:Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for 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 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Trough concentrations after multiple doses of tremelimumab (Ctrough)
Time Frame:Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Incidence and titers of anti-drug antibodies against tremelimumab
Time Frame:Day 1, Day 29, and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Incidence and titers of neutralizing antibodies against PF-06801591
Time Frame:Day 1, Day 29 and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Maximum observed plasma concentration of PF-06801591 (Cmax)
Time Frame:Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:
Measure:Time to maximum concentration of PF-06801591 (Tmax)
Time Frame:Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for 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 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for 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 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Safety Issue:
Description:

Details

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

Last Updated

March 9, 2021