Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab

Overview

This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.

Full Title of Study: “Phase 1 Dose Escalation Trial of Intra-Tumoral Injection of Sodium Iodide Simporter (NIS) Measles Virus (Edmonston Strain) in Combination With Atezolizumab in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 19, 2018

Detailed Description

Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8

Interventions

  • Biological: MV-NIS
    • This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
  • Biological: Atezolizumab
    • Atezolizumab will be administered every 3 weeks

Arms, Groups and Cohorts

  • Experimental: MV-NIS and Atezolizumab
    • MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab will be given at day 15 and then every 3 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
    • Time Frame: 28 days after MV-NIS administration for each dose cohort
    • To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab

Participating in This Clinical Trial

Key Inclusion Criteria:

  • Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS. – Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC. – Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. – Ability to provide informed consent. – Adequate hematological, liver and kidney function. – Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration. Key Exclusion Criteria:

  • Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration – Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation). – Pregnant women. – Nursing women. – Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment. – Allergy to measles vaccine or history of severe reaction to prior measles vaccination. – History of organ transplantation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vyriad, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alice Bexon, MD, Study Director, Vyriad, Inc.

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