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A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Last updated on December 18, 2018

FOR MORE INFORMATION
Study Location
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer, Triple-negative Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

triple-negative breast cancer

-Adequate bone marrow, kidney, and liver function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03674827
Pfizer
Recruiting
A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

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A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
A Ph 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (PF-06936308) For Advanced NSCLC And Metastatic TNBC
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer
  • Triple-negative Breast Cancer
Biological: PF-06936308
PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
Other Name: Vaccine-based immunotherapy regimen-2 (VBIR-2)
Experimental: PF-06936308
Dose escalation
Intervention: Biological: PF-06936308
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
97
Same as current
October 13, 2021
October 13, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03674827
C3621001
VBIR-2 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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