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Monoclonal Antibodies

Rilvegostomig, Volrustomig, Sabestomig, Pembrolizumab for Head and Neck Squamous Cell Carcinoma

Q: In how many diverse venues is this experimental examination currently being conducted?

This medical research is currently underway at 7 centers, including facilities in Bronx, Sacramento, and Shreveport among others. Opting for the nearest site can help reduce travel burdens when participating in this trial.

Q: Are individuals currently being admitted to participate in this trial?

As per information from clinicaltrials.gov, this particular study is not presently seeking participants. Initially shared on April 1st, 2024, the latest revision was made on April 11th, 2024. While recruitment for this trial is currently closed, it's worth noting that there are a substantial number of other studies actively enrolling individuals - approximately 840 trials in total.

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

Study 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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Presage BiosciencesLead Sponsor

8 Previous Clinical Trials

85 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,274 Previous Clinical Trials

288,613,406 Total Patients Enrolled

Study DirectorStudy DirectorPresage Biosciences

1,212 Previous Clinical Trials

499,257 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many diverse venues is this experimental examination currently being conducted?

"This medical research is currently underway at 7 centers, including facilities in Bronx, Sacramento, and Shreveport among others. Opting for the nearest site can help reduce travel burdens when participating in this trial."

Answered by AI

Are individuals currently being admitted to participate in this trial?

"As per information from clinicaltrials.gov, this particular study is not presently seeking participants. Initially shared on April 1st, 2024, the latest revision was made on April 11th, 2024. While recruitment for this trial is currently closed, it's worth noting that there are a substantial number of other studies actively enrolling individuals - approximately 840 trials in total."

Answered by AI

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