Back to resultsDose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
Primary Purpose
Recurrent Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MV-NIS
Atezolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Non-Small Cell Lung Cancer focused on measuring Lung Cancer Measles Nivolumab Opdivo
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MV-NIS and Atezolizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02919449
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyriad, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-Small Cell Lung Cancer
Keywords
Lung Cancer Measles Nivolumab Opdivo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MV-NIS and Atezolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
MV-NIS
Intervention Description
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
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab will be administered every 3 weeks
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
Description
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
Time Frame
28 days after MV-NIS administration for each dose cohort
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Bexon, MD
Organizational Affiliation
Vyriad, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
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