Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
Public ClinicalTrials.gov record NCT04541108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04541108
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- Rilvegostomig Biological
- Volrustomig Biological
- Sabestomig Biological
- Pembrolizumab Biological
- AZD9592 Biological
- AZD9592 + Rilvegostomig Combination Product
- AZD9592 + Volrustomig Combination Product
- AZD9592 + Sabestomig Combination Product
- AZD9592 + Pembrolizumab Combination Product
Biological · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 26, 2021 (Actual)
- Primary completion
- Dec 2031 (Estimated)
- Completion
- Dec 2031 (Estimated)
- Last update posted
- May 22, 2026
2021 – 2031
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LSU Health Sciences Center - Shreveport | Shreveport | Louisiana | 71115 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| UC Health | Cincinnati | Ohio | 45229 | — |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | — |
| Sarah Cannon Research Institute | Charleston | South Carolina | 29406 | — |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| University of Washington | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04541108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04541108 live on ClinicalTrials.gov.