Summary

for people ages 18 years and up (full criteria)
at Encinitas, California and other locations
study started
estimated completion

Description

Summary

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.

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

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.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

-Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer

-Adequate bone marrow, kidney, and liver function

You CAN'T join if...

  • 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 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
  • UC San Diego Medical Center - Hillcrest accepting new patients
    San Diego California 92103 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
Links
To obtain contact information for a study center near you, click here.
ID
NCT03674827
Phase
Phase 1
Study Type
Interventional
Last Updated