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Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
NCT04541108 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Volrustomig
- BIOLOGICAL Rilvegostomig
- BIOLOGICAL Sabestomig
Study Locations (12)
North Carolina
- University of North Carolina — Chapel Hill
- Wake Forest University Health Sciences — Winston-Salem
California
- UC Davis — Sacramento
Georgia
- Emory Winship Cancer Institute — Atlanta
Louisiana
- LSU Health Sciences Center - Shreveport — Shreveport
New York
- Montefiore Medical Center — The Bronx
Ohio
- UC Health — Cincinnati
Oregon
- Oregon Health & Science University (OHSU) — Portland
Pennsylvania
- University of Pennsylvania — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2031-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541108
The ClinicalTrials.gov registry entry for NCT04541108 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presage Biosciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04541108 reports 12 study locations spanning 11 distinct geographic areas — top geographies include North Carolina, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04541108 about?
NCT04541108 is a clinical study titled "Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies". 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 tum...
What is the current status of trial NCT04541108?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-07-26. Estimated completion is 2031-12.
What conditions does trial NCT04541108 study?
This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04541108?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Volrustomig (BIOLOGICAL), Rilvegostomig (BIOLOGICAL), Sabestomig (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04541108?
This trial is sponsored by Presage Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04541108 being conducted?
This trial has 12 study locations across California, Georgia, Louisiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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