Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Stopped early · Phase 1

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

In brief

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.

Key facts

Study ID

NCT03674827

Run by

Pfizer

People needed

36

Starts

2018-11-27

Expected to finish

2021-09-27

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• UCSD Medical Center - Encinitas — Encinitas, California, United States
• UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital) — La Jolla, California, United States
• UC San Diego Perlman Medical Offices — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• UCLA Hematology/Oncology - Parkside — Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• UCSD Medical Center - Vista — Vista, California, United States
• H Lee Moffitt Cancer Center & Research Institute Inc — Tampa, Florida, United States
• The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States
• Orland Park - University of Chicago Center for Advanced Care — Orland Park, Illinois, United States
• Horizon Oncology Research, LLC — Lafayette, Indiana, United States
• InnerVision Advanced Medical Imaging — Lafayette, Indiana, United States
• The University of Kansas Cancer Center, Investigational Drug Services — Fairway, Kansas, United States
• The University of Kansas Clinical Research Center — Fairway, Kansas, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute Downtown — Louisville, Kentucky, United States
• Norton Cancer Institute Pharmacy, Downtown Pharmacy — Louisville, Kentucky, United States
• Norton Hospital — Louisville, Kentucky, United States
• Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States

Full record on ClinicalTrials.gov

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