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

Phase 1

Terminated

• Conditions: Recurrent Non-Small Cell Lung Cancer
• Interventions: Biological: MV-NIS; Biological: Atezolizumab

• Registration Number: NCT02919449
• Lead Sponsor: Vyriad, Inc.

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

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-29
• Study Start: 2017-08-03
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Results First Submitted: 2021-03-02
• Status Verified: 2022-01
• Results First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Results First Posted: 2023-07-21
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MV-NIS and Atezolizumab	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.
MV-NIS and Atezolizumab	MV-NIS	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.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States