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

NCT ID: NCT02919449

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2018-01-19

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.

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

Conditions

Recurrent Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MV-NIS

Intervention Type: 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

Atezolizumab

Intervention Type: BIOLOGICAL

Atezolizumab will be administered every 3 weeks

Interventions

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

Intervention Type: BIOLOGICAL

Atezolizumab

Atezolizumab will be administered every 3 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyriad, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Bexon, MD

Role: STUDY_DIRECTOR

Vyriad, Inc.

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VYR-MV1-101

Identifier Type: -

Identifier Source: org_study_id