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Pembrolizumab Alone or in Combination with MK-0482 or MK-4830 for Head and Neck Squamous Cell Carcinoma

Phase < 1
Waitlist Available
Research Sponsored by Presage Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 4 days after microdose injection
Awards & highlights

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.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 4 days after microdose injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 4 days after microdose injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantification of Immune Cell Biomarkers by Immunohistochemistry (IHC), In Situ Hybridization (ISH), and/or Spatial Biology Platforms
Secondary study objectives
Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab Alone or in Combination with MK-0482 or MK-4830Experimental Treatment3 Interventions
Patient with HNSCC or STS with surface accessible lesions who are scheduled for tumor or regional node dissection as part of their standard treatment will be injected two to four days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of pembrolizumab as a single agent or in combination with MK-0482 or MK-4830. Each microdose is simultaneously injected in a columnar fashion through each of 5 or 8 needles by the CIVO Micodose Injection Device (MID) into a single solid tumor or effaced metastatic lymph node.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
MK-0482 + Pembrolizumab
2022
Completed Early Phase 1
~20
MK-4830 + Pembrolizumab
2022
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

Presage BiosciencesLead Sponsor
9 Previous Clinical Trials
100 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,175,093 Total Patients Enrolled
Study DirectorStudy DirectorPresage Biosciences
1,252 Previous Clinical Trials
504,366 Total Patients Enrolled
~4 spots leftby Sep 2025
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