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

NCT02923466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

  • Malignant Solid Tumour

Interventions

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

Sponsors & Collaborators

  • Vyriad, Inc.

    lead INDUSTRY

Principal Investigators

  • Alice Bexon, MD · CMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2022-02-05
Completion
2022-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923466 on ClinicalTrials.gov