← Back to Search

Monoclonal Antibodies

Intratumoral Microdosing for Head and Neck Cancer

Phase < 1
Recruiting
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 1 to 3 days after microdose injection
Awards & highlights

Summary

"This trial will study the effects of three different drugs on Head and Neck Squamous Cell Carcinoma tumors. The drugs will be administered directly into the tumor in small amounts using a specialized device. The

Who is the study for?
This trial is for individuals with accessible lesions from Head and Neck Squamous Cell Carcinoma (HNSCC), including Oral Squamous Cell Carcinoma, who are already scheduled for tumor removal surgery. Participants must have a lesion that can be reached for intratumoral drug delivery.Check my eligibility
What is being tested?
The study tests the effects of three drugs—Rilvegostomig, Volrustomig, Sabestomig—delivered directly into the tumor using a device called CIVO. These effects are compared to those of Pembrolizumab, another drug given in the same way.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site within the tumor, general immune-related side effects such as fatigue or flu-like symptoms due to Pembrolizumab and other tested drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 3 days after microdose injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 3 days after microdose injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab
Secondary outcome measures
Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rilvegostomig, Volrustomig, Sabestomig, PembrolizumabExperimental Treatment4 Interventions
HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, and pembrolizumab alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Presage BiosciencesLead Sponsor
9 Previous Clinical Trials
98 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,584 Total Patients Enrolled
Study DirectorStudy DirectorPresage Biosciences
1,230 Previous Clinical Trials
501,075 Total Patients Enrolled
~10 spots leftby Dec 2024