Clinical trial NCT02919449: Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Recurrent Non-Small Cell Lung Cancer
Keywords: Lung Cancer Measles Nivolumab Opdivo
Lead sponsor: Vyriad, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
timeFrame: 28 days after MV-NIS administration for each dose cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Vyriad, Inc.
name: Alice Bexon, MD
role: STUDY_DIRECTOR
References: