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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 3 days after microdose injection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab

Secondary study objectives

Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

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