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NCT06413095 · ClinicalTrials.gov registry record · Early Phase 1
PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS
A Early Phase 1 study, sponsored by Presage Biosciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT06413095: Completed Early Phase 1 study, sponsored by Presage Biosciences.
NCT06413095 is a Early Phase 1 study that has completed, run by Presage Biosciences. The registered enrollment target is 13 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06413095, a Early Phase 1 study, has completed, sponsored by Presage Biosciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native tumor microenvironment (TME) following intratumoral microdosing via the CIVO device in patients with surface accessible Head and Neck Squamous Cell Carcinoma (HNSCC) or Soft Tissue Sarcoma (STS) lesion(s) who are scheduled for tumor and/or regional node dissection as part of their standard treatment.
Primary Outcome
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around injection sites in resected patient samples 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, markers associated with macrophage polarization states (e.g., CD163), markers of infiltrati
Interventions
- BIOLOGICAL Pembrolizumab
- COMBINATION_PRODUCT MK-0482 + Pembrolizumab
- COMBINATION_PRODUCT MK-4830 + Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2023-06-22 |
| Phase | Early Phase 1 |
What the finished NCT06413095 record still lists
NCT06413095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06413095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06413095 about?
NCT06413095 is a clinical study titled "PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS". This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native tumor microenvironment (TME) following intratumoral ...
What is the current status of trial NCT06413095?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2022-06-01. Estimated completion is 2023-06-22.
What interventions are being tested in trial NCT06413095?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-0482 + Pembrolizumab (COMBINATION_PRODUCT), MK-4830 + Pembrolizumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06413095?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06413095's enrollment target sits among peer trials
13 1504th of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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