Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
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.
Checked against the public recordLast updated Aug 23, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Biological: PF-06936308
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCSD Medical Center - EncinitasEncinitas, California
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)La Jolla, California
- UC San Diego Perlman Medical OfficesLa Jolla, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- UCLA Hematology/OncologyLos Angeles, California
- UC San Diego Medical Center - HillcrestSan Diego, California
- UCLA Hematology/Oncology - ParksideSanta Monica, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
- UCSD Medical Center - VistaVista, California
- H Lee Moffitt Cancer Center & Research Institute IncTampa, Florida
- The University of Chicago Medical Center, CCD - Investigational Drug Service PharmacyChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 23, 2024. Always confirm current availability with the study team.