Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion

Description

Summary

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.

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

Details

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.

Keywords

Non-Small Cell Lung Cancer Triple-negative Breast Cancer Breast Neoplasms Lung Neoplasms Carcinoma, Non-Small-Cell Lung Triple Negative Breast Neoplasms Vaccines Immunologic Factors

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  • 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

Locations

  • UCSD Medical Center - Encinitas accepting new patients
    Encinitas California 92024 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037-0845 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital) accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Perlman Medical Offices accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • UC San Diego Medical Center - Hillcrest accepting new patients
    San Diego California 92103 United States
  • UCLA Hematology/Oncology - Parkside accepting new patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • UCSD Medical Center - Vista accepting new patients
    Vista California 92081 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT03674827
Phase
Phase 1
Study Type
Interventional
Last Updated