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Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Patients With Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT02923466
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Vyriad, Inc.

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. The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a monotherapy regimen selection phase (IT alone, IT then IV, or IV alone) and an expansion phase, designed to explore the safety and efficacy of the chosen monotherapy regimen alone or in combination with avelumab in patients with metastatic colorectal cancer. This phase contains a small dose de-escalation-re-escalation period to ensure the safety of the combination prior to opening the corresponding expansion cohort.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumour Biological: VSV-IFNβ-NIS Biological: VSV-IFNβ-NIS and avelumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VSV-IFNβ-NIS
VSV-IFNβ-NIS will be administered intratumorally as a single dose on day 1.
Biological: VSV-IFNβ-NIS
Intratumoral injection of a single dose of VSV-IFNβ-NIS

Experimental: Selection of VSV-IFNβ-NIS Monotherapy
VSV-IFNβ-NIS will be administered either intratumorally, intravenously or with a combination of intratumorally and intravenously as a single dose on day 1.
Biological: VSV-IFNβ-NIS
Intratumoral injection of a single dose of VSV-IFNβ-NIS

Experimental: VSV-IFNβ-NIS and avelumab

VSV-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.

Biological: VSV-IFNβ-NIS and avelumab
Intratumoral injection of a single dose of VSV-IFNβ-NIS and intravenous infusion of avelumab




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of VSV-IFNβ-NIS Monotherapy and Combination Therapy [ Time Frame: 21 days after VSV-IFNβ-NIS Monotherapy or Combination Therapy for each dose cohort ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02923466


Contacts
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Contact: Barb H Duckett 507-289 0944 bduckett@vyriad.com

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Tamara Leon    305-243-0865    txl351@med.miami.edu   
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Moe Norton-Westbrook    612-624-9390    norto228@umn.edu   
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205/2664
Contact: Mary E Scholz    614-722-3654    Mary.Scholz@NationwideChildrens.org   
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Jenna Hove    605-312-3337    jenna.hove@health.org   
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: Catherine Raj    972-566-3064    craj@marycrowley.org   
Sponsors and Collaborators
Vyriad, Inc.

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Responsible Party: Vyriad, Inc.
ClinicalTrials.gov Identifier: NCT02923466     History of Changes
Other Study ID Numbers: VYR-VSV2-101
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vyriad, Inc.:
refractory solid tumor
Additional relevant MeSH terms:
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Neoplasms
Interferon-beta
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents