RecruitingPhase 2NCT03708224

Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

A Phase II Study of Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck


Sponsor

Alain Algazi

Enrollment

55 participants

Start Date

Mar 8, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

To determine the effect of neoadjuvant atezolizumab alone or in combination with other immune modulating agents on T-cell infiltration in advanced SCCHN. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving a single dose of an immune checkpoint drug (pembrolizumab) before surgery — a strategy called neoadjuvant immunotherapy — helps prime the immune system to better fight head and neck squamous cell carcinoma (cancer of the mouth, throat, and related areas), by analyzing how the tumor changes between biopsy and surgical removal. **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck squamous cell carcinoma (SCCHN) that is planned for surgical removal - Your cancer has not yet been treated - You are well enough to carry out daily activities (ECOG 0 or 1) - Your blood counts and organ function meet minimum thresholds - A tumor biopsy sample is available (or you agree to have one taken) **You may NOT be eligible if...** - You have an active autoimmune disease that requires immune-suppressing treatment - You have received prior treatment for this head and neck cancer - You are on steroids or other immune-suppressing medications - You are pregnant or breastfeeding - You have a history of severe immune-related reactions to prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given intravenously (IV)

BIOLOGICALTocilizumab

Given IV

BIOLOGICALTiragolumab

Given IV


Locations(1)

University of San Francisco, California

San Francisco, California, United States

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NCT03708224


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