At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592
In Brief
A Early Phase 1 clinical trial evaluating Rilvegostomig, Volrustomig, and 7 other interventions for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 17 participants across 7 sites.
Detailed Summary
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents, either as single agents or as AZD9592 drug combinations with the evaluated biologics, will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device.
Study Details
Timeline
Arms & Interventions
HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, AZD9592, and pembrolizumab as single agents and AZD9592 drug combinations with the evaluated biologics.
Interventions
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.
Intratumoral microdose injection by the CIVO device.