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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 is a Early Phase 1 study that has completed, run by Presage Biosciences. The registered enrollment target is 13 participants.

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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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • COMBINATION_PRODUCT MK-0482 + Pembrolizumab
  • COMBINATION_PRODUCT MK-4830 + Pembrolizumab

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2022-06-01
Est. Completion 2023-06-22
Phase Early Phase 1

Sponsor

Presage Biosciences

8 total trials

What the Registry Record Tells You About NCT06413095

The ClinicalTrials.gov registry entry for NCT06413095 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presage Biosciences, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT06413095 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.