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Checkpoint Inhibitor

Radiation Therapy for Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Arnaud Bewley, MD
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 up to 3 years
Awards & highlights

Study Summary

This trial tests whether atezolizumab can shrink tumors before surgery in patients with head and neck squamous cell cancer that has spread to the lymph nodes.

Eligible Conditions
  • Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Complete Response (pCR)
Secondary outcome measures
Major Pathologic Response (mPR)
Number of Adverse Events
Number of Participants With Overall Response
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, surgery, radiation therapy)Experimental Treatment3 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Radiation Therapy
2017
Completed Phase 3
~7250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850

Find a Location

Who is running the clinical trial?

Arnaud Bewley, MDLead Sponsor
Arnaud BewleyLead Sponsor
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,666 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05110781 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Treatment (atezolizumab, surgery, radiation therapy)
Squamous Cell Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05110781 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110781 — Phase 2

Frequently Asked Questions

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

What safety protocols are being implemented to ensure the efficacy of Radiation Therapy?

"We assigned Radiation Therapy a score of 2, as there is existing evidence for its safety but no data to confirm its efficacy."

Answered by AI

Is enrollment still possible for this trial?

"Affirmative. Per the information published on clinicaltrials.gov, this medical investigation is currently enlisting participants; it was posted in December 2021 and revised in January 2022. The trial requires 18 individuals from 1 site to join."

Answered by AI

Is this investigation a pioneering effort?

"Since 2008, Radiation Therapy has been the focus of numerous studies. The initial research was sponsored by Hoffmann-La Roche and involved 720 patients, eventually leading to Phase 2 approval for this medication. Currently, 351 trials are active in 1646 cities within 74 countries worldwide."

Answered by AI

How many participants have signed up to take part in the clinical trial so far?

"That is correct. Clinicaltrials.gov reveals that this medical trial, which was first published on December 7th 2021, is actively recruiting participants now. 18 patients are needed from a single clinical site for the study's completion."

Answered by AI

What maladies can be remedied with Radiation Therapy?

"Through the use of Radiation Therapy, small cell lung cancer (SCLC), malignant neoplasms and non-small cell lung carcinoma can be addressed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site
Arnaud Bewley, MD 2021. "Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05110781.
~0 spots leftby Apr 2025
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