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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.
- 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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Descriptive Information | |||||
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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 |
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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 |
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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 | 100 | ||||
Original Estimated Enrollment ICMJE | 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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |