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Trial record 3 of 3 for:    Edmonston Strain of Measles Virus,

Trial of Measles Virotherapy in Combination With Atezolizumab in Patients With Metastatic Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified August 2017 by Vyriad, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02919449
First Posted: September 29, 2016
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vyriad, Inc.
  Purpose
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.

Condition Intervention Phase
Recurrent Non-Small Cell Lung Cancer Biological: MV-NIS Biological: Atezolizumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Vyriad, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of MV-NIS in combination with Atezolizumab [ Time Frame: 28 days after MV-NIS administration for each dose cohort ]

Estimated Enrollment: 42
Actual Study Start Date: August 3, 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MV-NIS and Atezolizumab
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.
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
Biological: Atezolizumab
Atezolizumab will be administered every 3 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919449


Contacts
Contact: Barb H Duckett 507-398 4598 bduckett@vyriad.com

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Burton    507-284-8440    burton@mayo.edu   
Principal Investigator: Julian Molina, MD, PhD         
Sponsors and Collaborators
Vyriad, Inc.
  More Information

Responsible Party: Vyriad, Inc.
ClinicalTrials.gov Identifier: NCT02919449     History of Changes
Other Study ID Numbers: VYR-MV1-101
First Submitted: September 28, 2016
First Posted: September 29, 2016
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vyriad, Inc.:
Lung Cancer Measles Nivolumab Opdivo

Additional relevant MeSH terms:
Measles
RNA Virus Infections
Virus Diseases
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs