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
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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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