Trial of Measles Virotherapy in Combination With Atezolizumab in Patients With Metastatic Non-Small Cell Lung Cancer
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/9/2018 |
Start Date: | August 3, 2017 |
End Date: | January 19, 2018 |
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)
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.
attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and
metastatic NSCLC.
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.
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