Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

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NCT03674827

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Study Location
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

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.

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


- 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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Non-Small Cell Lung Cancer, Triple-negative Breast CancerVaccine-Based Immunotherapy Regimen For NSCLC and TNBC
NCT03674827
  1. Los Angeles, California
  2. Los Angeles, California
  3. Seattle, Washington
  4. Encinitas, California
  5. La Jolla, California
  6. La Jolla, California
  7. La Jolla, California
  8. La Jolla, California
  9. San Diego, California
  10. Santa Monica, California
  11. Santa Monica, California
  12. Vista, California
  13. Tampa, Florida
  14. Tampa, Florida
  15. Chicago, Illinois
  16. Chicago, Illinois
  17. New Lenox, Illinois
  18. Orland Park, Illinois
  19. Lafayette, Indiana
  20. Fairway, Kansas
  21. Fairway, Kansas
  22. Westwood, Kansas
  23. Louisville, Kentucky
  24. Louisville, Kentucky
  25. Louisville, Kentucky
  26. Louisville, Kentucky
  27. Creve Coeur, Missouri
  28. Saint Louis, Missouri
  29. Saint Louis, Missouri
  30. Saint Louis, Missouri
  31. Saint Louis, Missouri
  32. Saint Peters, Missouri
  33. Nashville, Tennessee
  34. Nashville, Tennessee
  35. Salt Lake City, Utah
  36. Salt Lake City, Utah
  37. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
Official Title  ICMJE A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of a Vaccine-Based Immunotherapy Regimen-2 (VBIR-2) (PF-06936308) for Advanced Non-small Cell Lung Cancer and Metastatic Triple-negative Breast Cancer
Brief Summary

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.

Detailed Description

The study is divided into two parts, Dose Escalation (Part 1) in participants with NSCLC and TNBC without acceptable alternative treatment options, followed by Dose Expansion (Part 2) in participants with NSCLC who have progressed on or after treatment with platinum-based chemotherapy and treatment with 1 immune checkpoint inhibitor, given concurrently or sequentially with chemotherapy.

Part 1 has been completed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Triple-negative Breast Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Experimental: Dose escalation (Part 1)
    Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.
    Intervention: Biological: PF-06936308
  • Experimental: Dose Expansion (Part 2)
    Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.
    Intervention: Biological: PF-06936308
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2021)		100
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)		97
Estimated Study Completion Date  ICMJE December 25, 2023
Estimated Primary Completion Date December 25, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674827
Other Study ID Numbers  ICMJE C3621001
VBIR-2 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP