CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia

Conditions

• Solid Tumour

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MVC-101 — BIOLOGICAL
  Intratumoural microdose injection by the CIVO device.
• Nivolumab — BIOLOGICAL
  Intratumoural microdose injection by the CIVO device.
• MVC-101 + Nivolumab — COMBINATION_PRODUCT
  Intratumoural microdose injection by the CIVO device.

Study Details

This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in microdose quantities via the CIVO device in patients with surface accessible solid tumours for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

Key Dates

Start date

Sep 15, 2021

Status verified

Jul 2022

Primary completion

Jun 5, 2022

Completion

Jun 5, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: MVC-101 and Nivolumab
  Patients with HNSCC who are scheduled for surgical biopsy or tumour resection surgery will be injected at least four hours to up to three days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline and solution stabilizer), a pre-cleaved/pre-activated drug control (cMVC-101), MVC-101 (the prodrug), or nivolumab as single agents or as combinations. Each drug will be delivered in subtherapeutic microdoses, and each microdose is simultaneously injected in a columnar fashion through each of 3, 5, or 8 needles (in a device configuration determined by tumour dimensions) into a single solid tumour or effaced metastatic lymph node.

Primary Outcome Measure

Quantification of Cell Death and Immune Cell Biomarkers by IHC and In-Situ Hybridization [ Time Frame: 4 hours-7 days after microdose injection ]