MedTrace Logo

CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia

NCT04891718 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2022-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumour

Interventions

BIOLOGICAL

MVC-101

Intratumoural microdose injection by the CIVO device.

BIOLOGICAL

Nivolumab

Intratumoural microdose injection by the CIVO device.

COMBINATION_PRODUCT

MVC-101 + Nivolumab

Intratumoural microdose injection by the CIVO device.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director · Presage Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-06-05
Completion
2022-06-05
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04891718 on ClinicalTrials.gov