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

  • Interventional
  • Recruiting
  • NCT03674827
Eligibility Details Visit Clinicaltrials.gov

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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:

         - 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

At a Glance

National Government IDNCT03674827

IRB#IRB18-0662

Lead SponsorPfizer

Lead PhysicianRita Nanda

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting