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

Vyriad

Status and phase

Terminated

Phase 1

Conditions

Recurrent Non-Small Cell Lung Cancer

Treatments

Biological: Atezolizumab

Biological: MV-NIS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02919449

VYR-MV1-101

Details and patient eligibility

About

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 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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.