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NCT04541108 · ClinicalTrials.gov registry record · Early Phase 1
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
A Early Phase 1 study of Solid Tumor, sponsored by Presage Biosciences.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 12
- Study locations
NCT04541108: Recruiting Early Phase 1 study of Solid Tumor, sponsored by Presage Biosciences.
NCT04541108 is a Early Phase 1 study of Solid Tumor that is actively recruiting participants, run by Presage Biosciences. The registered enrollment target is 15 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (93% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541108, a Early Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Presage Biosciences.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
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/G
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 |
What NCT04541108 shows while recruiting
NCT04541108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (93% lower).
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.
NCT04541108 lists 12 locations in 11 states (North Carolina, California, Georgia).
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.
What interventions are being tested in trial NCT04541108?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Volrustomig (BIOLOGICAL), Rilvegostomig (BIOLOGICAL), Sabestomig (BIOLOGICAL).
Who is sponsoring clinical trial NCT04541108?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04541108's enrollment target sits among peer trials
15 184th of 196 higher than 13 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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