Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

NCT03674827

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Non-Small Cell Lung Cancer, Triple-negative Breast Cancer

Interventions: PF-06936308

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (34)
  • Encinitas, California, United States
  • La Jolla, California, United States
  • La Jolla, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • Santa Monica, California, United States
  • Santa Monica, California, United States
  • Vista, California, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • New Lenox, Illinois, United States
  • Orland Park, Illinois, United States
  • Lafayette, Indiana, United States
  • Lafayette, Indiana, United States
  • Fairway, Kansas, United States
  • Fairway, Kansas, United States
  • Westwood, Kansas, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • Louisville, Kentucky, United States
  • City of Saint Peters, Missouri, United States
  • Creve Coeur, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Nashville, Tennessee, United States
  • + 4 more on CT.gov