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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 23, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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.
- 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.