Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors
Phase 1 Trial of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta (VSV-IFNβ-NIS) Monotherapy and in Combination With Avelumab, in Patients With Refractory Solid Tumors
1 other identifier
interventional
76
1 country
6
Brief Summary
This is a three-part open label phase 1 study designed to determine the safety profile, MTD, PK and tumor and biomarker response after IT or IV administration of a single dose of VSV-IFNβ-NIS, or combined IT followed by IV VSV-IFNβ-NIS, with or without IV avelumab every two weeks, in patients with refractory advanced/metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2017
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedApril 27, 2022
April 1, 2022
4.8 years
September 30, 2016
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of VSV-IFNβ-NIS Monotherapy and Combination Therapy
21 days after VSV-IFNβ-NIS Monotherapy or Combination Therapy for each dose cohort
Study Arms (3)
VSV-IFNβ-NIS
EXPERIMENTALVSV-IFNβ-NIS will be administered intratumorally as a single dose on day 1.
Selection of VSV-IFNβ-NIS Monotherapy
EXPERIMENTALVSV-IFNβ-NIS will be administered either intratumorally, intravenously or with a combination of intratumorally and intravenously as a single dose on day 1.
VSV-IFNβ-NIS and avelumab
EXPERIMENTALVSV-IFNβ-NIS will be administered as determined in arm 2 as a single dose on day 1. Avelumab will be administered intravenously every 2 weeks starting on day 1.
Interventions
Intratumoral injection of a single dose of VSV-IFNβ-NIS
Intratumoral injection of a single dose of VSV-IFNβ-NIS and intravenous infusion of avelumab
Eligibility Criteria
You may qualify if:
- Be \> 18 years of age on day of signing informed consent.
- Have a histologically confirmed diagnosis of an advanced and/or metastatic solid tumor that is relapsed and/or refractory to standard therapy, as defined as progression on at least one prior line of therapy in the relapsed/metastatic setting and no existing options are felt to provide clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Adequate hematological, liver and kidney function.
- Must be willing to implement contraception throughout study and for 120 days after receiving the study drug.
You may not qualify if:
- Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
- Has a history of a bone marrow or solid organ transplant.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vyriad, Inc.lead
Study Sites (6)
University of Miami
Miami, Florida, 33136, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205/2664, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Bexon, MD
CMO
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 4, 2016
Study Start
April 17, 2017
Primary Completion
February 5, 2022
Study Completion
April 22, 2022
Last Updated
April 27, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share