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Atezolizumab for Head and Neck Squamous Cell Carcinoma
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Completed definitive local therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to the first documented disease recurrence, or disease progression (per recist v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 65 months)
Awards & highlights
Study Summary
This trial will test if atezolizumab, an immunotherapy drug, can help treat patients with SCCHN, a type of head and neck cancer, better than placebo.
Who is the study for?
This trial is for adults with high-risk advanced squamous cell carcinoma of the head and neck who've completed local therapy without metastasis. Participants must have stable organ function, no autoimmune diseases or severe allergies to antibodies, not be pregnant or breastfeeding, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests Atezolizumab (an anti-PD-L1 antibody) against a placebo as additional treatment after primary local therapy in patients with head and neck cancer. It aims to see if Atezolizumab can prevent cancer from returning.See study design
What are the potential side effects?
Atezolizumab may cause immune-related side effects like inflammation in organs, fatigue, infusion reactions similar to allergic responses, skin issues, hormone gland problems (like thyroid), and infections due to weakened immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as Squamous Cell Carcinoma of the Head and Neck.
Select...
I have finished all my initial cancer treatments.
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My blood thinner medication dose has been stable.
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My scans show no cancer spread to other parts.
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I know my HPV status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to the first documented disease recurrence, or disease progression (per recist v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 65 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to the first documented disease recurrence, or disease progression (per recist v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 65 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-assessed Event Free Survival (EFS)
Secondary outcome measures
Change from baseline in physical function and Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire
Incidence of ADA Response to Atezolizumab
Independent Review Facility-assessed Event Free Survival (IRF-assessed EFS)
+3 moreSide effects data
From 2015 Phase 2 & 3 trial • 149 Patients • NCT0196846020%
NAUSEA
16%
SOMNOLENCE
10%
DIZZINESS
8%
fatigue
8%
tremor
6%
insomnia
4%
orthostatic hypotension
4%
nasopharyngitis
2%
ACUTE MYOCARDIAL INFARCTION
2%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
P2B001 Treatment A
P2B001 Treatment B
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PlaceboExperimental Treatment1 Intervention
Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
Group II: AtezolizumabActive Control1 Intervention
Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,648 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,096 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the nose area and is not melanoma.I haven't had cancer, except for low-risk types, in the last 5 years.My cancer is confirmed as Squamous Cell Carcinoma of the Head and Neck.I have finished all my initial cancer treatments.My blood thinner medication dose has been stable.I have not used unapproved drugs for my cancer unless combined with approved ones.I have had treatments that affect my whole body after completing local therapies.My scans show no cancer spread to other parts.My cancer has spread or gotten worse after initial treatment.My last scan showed my cancer hasn’t worsened after treatment.I have high calcium levels in my blood that are causing symptoms.I know my HPV status.I have had a previous transplant of stem cells or an organ.I have or had an autoimmune disease or immune deficiency.I am currently on medication for Hepatitis B.My blood and organs are functioning well.I have active tuberculosis.I am taking medication that weakens my immune system.I have a serious heart condition.I am currently receiving treatment that boosts my immune system.I have had surgery or radiotherapy as my only treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Atezolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for Placebo to have any negative effects on test subjects?
"There is some evidence of efficacy and multiple rounds of data supporting safety, so the Power team rated Placebo a 3 for safety."
Answered by AI
Are patients still being recruited for this experiment?
"Unfortunately, this particular trial is no longer recruiting patients, as is evident from the clinicaltrials.gov website. The trial was originally posted on April 3rd, 2018 but was most recently updated on September 23rd, 2022. Although this study is not looking for candidates anymore, there are 3106 other trials actively accepting participants right now."
Answered by AI
Why is it that Placebo is given to patients?
"Placebo is most commonly used for the treatment of small cell lung cancer (sclc). It can also be prescribed to treat a variety of other conditions such as malignant neoplasms, non-small cell lung carcinoma, and postoperative care."
Answered by AI
Is this a new type of clinical trial?
"Placebo has a long and well-documented research history, with the first study being sponsored by Genentech, Inc. in 2008. Since the initial trial, which involved 720 participants, Placebo has undergone Phase 2 drug approval and is currently being studied in 361 live trials taking place in 1668 cities and 74 countries."
Answered by AI
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