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

NCT02919449 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: VYR-MV1-101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Non-Small Cell Lung Cancer

Keywords

Lung Cancer Measles Nivolumab Opdivo

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab

  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

  28 days after MV-NIS administration for each dose cohort

Study Arms (1)

MV-NIS and Atezolizumab

EXPERIMENTAL

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.

Biological: MV-NIS; Biological: Atezolizumab

Interventions

MV-NIS BIOLOGICAL

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

MV-NIS and Atezolizumab

Atezolizumab BIOLOGICAL

Atezolizumab will be administered every 3 weeks

MV-NIS and Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyriad, Inc.: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Study was closed prematurely due to administrative reasons.

Results Point of Contact

• Title: Alice Bexon MD Chief Medical Officer
• Organization: Vyriad

alice.bexon@bexonclinical.com

+1-617-417-7300

Study Officials

• Alice Bexon, MD

  Vyriad, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: August 3, 2017
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)