Clinical Trials /

Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

NCT03674827

Description:

Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer. Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.

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

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03674827

Trial Eligibility

Document

Title

  • Brief Title: Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
  • Official Title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES AND TREATMENT INTENSIFICATION OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN-2 (VBIR-2) (PF-06936308) FOR ADVANCED NON-SMALL CELL LUNG CANCER AND METASTATIC TRIPLE-NEGATIVE BREAST CANCER

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)Dose escalation (Part 1)
PF-06936308Vaccine-based immunotherapy regimen-2 (VBIR-2)Dose Expansion (Part 2)

Purpose

Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung cancer and metastatic triple-negative breast cancer. Part 2 will evaluate the safety, pharmacokinetics and pharmacodynamics, immunogenicity and preliminary evidence of efficacy of the Expansion dose of VBIR-2 in participants with advanced or metastatic non-small cell lung cancer.

Detailed Description

      The study is divided into two parts, Dose Escalation (Part 1) in participants with NSCLC and
      TNBC without acceptable alternative treatment options, followed by Dose Expansion (Part 2) in
      participants with NSCLC who have progressed on or after treatment with platinum-based
      chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or
      sequentially with chemotherapy.

      Part 1 has been completed.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation (Part 1)ExperimentalParticipants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.
  • PF-06936308
Dose Expansion (Part 2)ExperimentalParticipants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.
  • PF-06936308

Eligibility Criteria

        Inclusion Criteria:

        Part 1:Histological or cytological diagnosis of non-small cell lung cancer or
        triple-negative breast cancer. Adequate bone marrow, renal and liver function.

        Part 2: Histological or cytological diagnosis of metastatic non-small cell lung cancer
        previously treated with 1 or 2 regimens in metastatic setting including a CPI and
        platinum-based chemotherapy. Adequate bone marrow, renal and liver function.

        Exclusion Criteria:

          -  Known symptomatic brain metastases

          -  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:To evaluate Clinical Benefit Rate (CBR)
Time Frame:Participant will have CT scans/MRI every 8 weeks until disease progression for up to 3 years to measure change from baseline
Safety Issue:
Description:Proportion of participants who achieve complete response, partial response or stable disease for more than 6 months at 12, 24 and 36 months using RECIST 1.1. criteria.

Secondary Outcome Measures

Measure:Tremelimumab and sasanlimab 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 sasanlimab (Cmax).
Measure:Tremelimumab and sasanlimab 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 sasanlimab (Tmax)
Measure:Tremelimumab and sasanlimab 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 sasanlimab
Measure:Tremelimumab and sasanlimab 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 sasanlimab (Ctrough)
Measure:Anti drug antibody (ADA) response of tremelimumab and sasanlimab 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 sasanlimab
Measure:Objective response rate using RECIST 1.1
Time Frame:Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Safety Issue:
Description:Proportion of participants who achieve complete response or partial response.
Measure:Duration of response using RECIST 1.1
Time Frame:Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Safety Issue:
Description:Median time from first response (complete or partial) until disease progression for up to 3 years in responders.
Measure:Progression-free survival using RECIST 1.1
Time Frame:Participant will have CT scans/MRI at baseline and every 8 weeks until disease progression for up to 3 years
Safety Issue:
Description:Kaplan-Meier curve for progression up to 3 years.

Details

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

Last Updated

August 12, 2021