A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | November 27, 2018 |
End Date: | November 11, 2021 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
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
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.
of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung
cancer and metastatic triple-negative breast cancer.
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.
criteria, this study will evaluate the first-in-patient safety, PK, PD and early signs of
efficacy of the vaccine-based immunotherapy regimen.
Inclusion Criteria: -Histological or cytological diagnosis of non-small cell lung cancer or
triple-negative breast cancer
-Adequate bone marrow, kidney, and liver function
Exclusion Criteria:
- 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
We found this trial at
16
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Seattle, Washington 98195
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