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A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

NCT03674827

Description:

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung cancer and metastatic triple-negative breast cancer.

Related Conditions:
  • Breast Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
  • Official Title: A Ph 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (PF-06936308) For Advanced NSCLC And Metastatic TNBC

Clinical Trial IDs

  • ORG STUDY ID: C3621001
  • SECONDARY ID: VBIR-2
  • NCT ID: NCT03674827

Conditions

  • Non-Small Cell Lung Cancer
  • Triple-negative Breast Cancer

Interventions

DrugSynonymsArms
PF-06936308Vaccine-based immunotherapy regimen-2 (VBIR-2)PF-06936308

Purpose

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung cancer and metastatic triple-negative breast cancer.

Detailed Description

      By enrolling patients with advanced NSCLC and metastatic TNBC according to the enrollment
      criteria, this study will evaluate the first-in-patient safety, PK, PD and early signs of
      efficacy of the vaccine-based immunotherapy regimen.
    

Trial Arms

NameTypeDescriptionInterventions
PF-06936308ExperimentalDose escalation

    Eligibility Criteria

            Inclusion Criteria: -Histological or cytological diagnosis of non-small cell lung cancer or
            triple-negative breast cancer
    
            -Adequate bone marrow, kidney, and liver function
    
            Exclusion Criteria:
    
              -  ECOG performance status greater than or equal to 2
    
              -  concurrent immunotherapy
    
              -  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, such as cardiac demand
                 pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep
                 brain stimulators.
    
              -  Presence of any surgical or traumatic metal implants at the site of administration
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence and grade of treatment-emergent adverse events including DLTs
    Time Frame:Baseline up to Day 29 in Cycle 1 (each cycle is 4 months)
    Safety Issue:
    Description:DLTs in order to determine the maximum tolerated dose

    Secondary Outcome Measures

    Measure:To evaluate the immune response elicited by VBIR 2 to selected tumor antigens.
    Time Frame:Baseline up to Cycle 1 Day 85 (each cycle is 4 months), at Day 1 and Day 99 of Cycle 2; every 5 months therafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Cellular immune response specific to selected tumor antigens.
    Measure:To evaluate the antibody response to selected tumor-antigens
    Time Frame:Baseline up to Day 85 Cycle 1 (each cycle is 4 months); at Day 1 and Day 99 Cycle 2; every 5 months thereafter up to Mont 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Antibody response to selected tumor-antigens
    Measure:Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter (Cmax)
    Time Frame:Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Maximum observed plasma concentration of tremelimumab and PF-06801591 (Cmax).
    Measure:Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter (Tmax)
    Time Frame:Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Time to maximum concentration of tremelimumab and PF-06801591 (Tmax)
    Measure:Tremelimumab and anti PD-1 (PF-06801591) single dose PK parameter AUC
    Time Frame:Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Area under the curve from time zero extrapolated to infinity of tremelimumab and PF-06801591
    Measure:Tremelimumab and anti PD-1 (PF-06801591) after multiple doses PK parameter (Ctrough)
    Time Frame:Pre-dose on Day 1, Day 3-6, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each cycle is 4 months); pre-dose on Day 1 and Day 29 on Cycle 2; every 5 months thereafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Trough concentration after multiple doses of tremelimumab and PF-06801591 (Ctrough)
    Measure:the anti drug antibody (ADA) response of tremelimumab and anti PD 1 (PF 06801591) after SC administration with the other components.
    Time Frame:Day 1, Day 29 and Day 85 on Cycle 1 (each cycle is 4 months); Day 29 on Cycle 2, every 4 months thereafter up to Month 22; every 6 months thereafter up to 3 years
    Safety Issue:
    Description:Incidence and titers of anti-drug antibodies against tremelimumab and PF-06801591

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Pfizer

    Last Updated