Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Triple-negative Breast Cancer; Non-Small Cell Lung Cancer

Treatments: Biological: PF-06936308

Study type: Interventional

Funder types: Industry

Identifiers

NCT03674827

C3621001

VBIR-2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dose escalation (Part 1)

Experimental group

Description:

Participants with NSCLC or TNBC were enrolled at escalating dose levels s of the VBIR-2 regimen.

Treatment:

Biological: PF-06936308

Dose Expansion (Part 2)

Experimental group

Description:

Participants with metastatic NSCLC will be enrolled at the expansion dose level identified during Part 1 of the study.

Treatment:

Biological: PF-06936308