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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.

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE April 17, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Maximum Tolerated Dose (MTD) of VSV-IFNβ-NIS [ Time Frame: 28 days after VSV-IFNβ-NIS administration for each dose cohort ]
Change History Complete list of historical versions of study NCT02923466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Patients With Refractory Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Solid Tumour
Intervention  ICMJE
  • Biological: VSV-IFNβ-NIS
    Intratumoral injection of a single dose of VSV-IFNβ-NIS
  • Biological: VSV-IFNβ-NIS and avelumab
    Intratumoral injection of a single dose of VSV-IFNβ-NIS and intravenous infusion of avelumab
Study Arms  ICMJE
  • Experimental: VSV-IFNβ-NIS
    VSV-IFNβ-NIS will be administered intratumorally as a single dose on day 1.
    Intervention: Biological: 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.
    Intervention: Biological: 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.

    Intervention: Biological: VSV-IFNβ-NIS and avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
93
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
42
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barb H Duckett 507-289 0944 bduckett@vyriad.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923466
Other Study ID Numbers  ICMJE VYR-VSV2-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Vyriad, Inc.
Study Sponsor  ICMJE Vyriad, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vyriad, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP