Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Condition(s) studied
Investigational drug(s) / intervention(s)
Rilvegostomig: Intratumoral microdose injection by the CIVO device.
Volrustomig: Intratumoral microdose injection by the CIVO device.
Sabestomig: Intratumoral microdose injection by the CIVO device.
Pembrolizumab: Intratumoral microdose injection by the CIVO device.
AZD9592: Intratumoral microdose injection by the CIVO device
AZD9592 + Rilvegostomig: Intratumoral microdose injection by the CIVO device
AZD9592 + Volrustomig: Intratumoral microdose injection by the CIVO device
AZD9592 + Sabestomig: Intratumoral microdose injection by the CIVO device
AZD9592 + Pembrolizumab: Intratumoral microdose injection by the CIVO device
Study summary
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors 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.
Eligibility
Primary outcome measure(s)
- Quantification of Selected Pharmacodynamic Biomarkers as Specified in Substudies by IHC, ISH, and/or Spatial Biology Platforms — 4 hours-7 days after microdose injection
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites in each resected patient sample by IHC, ISH, or spatial biology platforms. An aggregate analysis of this quantification may be done across patient samples in each substudy to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to biomarkers for cell death (e.g. cleaved caspase 3), T-cells (e.g. CD3, CD8/Granzyme B, CD4), natural killer (NK)/myeloid cells (e.g. CD56/Granzyme B, CD86, CD68, CD163), and proinflammatory cytokines (e.g., interferon gamma, tumor necrosis factor alpha, interferon gamma-induced protein 10).
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| LSU Health Sciences Center - Shreveport | Shreveport | Louisiana | |
| Montefiore Medical Center | The Bronx | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| UC Health | Cincinnati | Ohio | |
| Oregon Health & Science University (OHSU) | Portland | Oregon | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| Sarah Cannon Research Institute | Charleston | South Carolina | |
| MUSC Hollings Cancer Center | Charleston | South Carolina | |
| University of Washington | Seattle | Washington |
On this site
📄 Keytruda (pembrolizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04541108 on ClinicalTrials.gov ↗ ← All trials in the USA