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Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923466
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Vyriad, Inc.

Study Description
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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.

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

Detailed Description:

The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a monotherapy IV regimen selection phase 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. Monotherapy will also be explored in patients with pheochromocytoma and NET.

Patients are required to have at least 1 measurable lesion per RECIST 1.1, and in the IT-containing arms this lesion should be amenable for a one-time IT injection of VSV-IFNβ-NIS. At least one patient per IT cohort is required to have at least 2 measurable lesions per RECIST 1.1, one for a one-time IT injection of VSV-IFNβ-NIS and one to be used as a control. Priority enrollment in the IT-containing arms will be granted to patients with 2 measurable lesions per RECIST 1.1. At least one patient per dose level should have metastatic colorectal cancer. In order to fulfil these requirements, at least 3 or 4 patients will be required per escalation dose cohort. Other tumor types of particular interest based on prior experience with VSV or oncolytic viruses include malignant melanoma and endometrial cancer. When more than one cohort is open simultaneously, slot assignment will be determined by the sponsor in consultation with the PIs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 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
Actual Primary Completion Date : February 5, 2022
Actual Study Completion Date : April 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205/2664
United States, South Dakota
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Vyriad, Inc.
Investigators
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Principal Investigator: Alice Bexon, MD CMO
More Information
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Responsible Party: Vyriad, Inc.
ClinicalTrials.gov Identifier: NCT02923466    
Other Study ID Numbers: VYR-VSV2-101
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Avelumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs