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

Recurrent Non-Small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02919449
• Other study ID #: VYR-MV1-101
• Status: Terminated
• Phase: Phase 1
• Start date: August 3, 2017
• Est. completion date: January 19, 2018

Study information

• Verified date: January 2022
• Source: Vyriad, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Measles
• Recurrent Non-Small Cell Lung Cancer

Intervention

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
• Atezolizumab
Atezolizumab will be administered every 3 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Vyriad, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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