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Monoclonal Antibodies
Radiotherapy + Atezolizumab for Head and Neck Cancer
Phase 1 & 2
Recruiting
Led By Sana Karam
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absolute neutrophil count (ANC) ≥1.5 x 109/L (≥ 1500 per mm3) without granulocyte colony-stimulating factor support.
Histologically or cytologically confirmed: stage II-IVB oral cavity, stage III-IVB larynx, stage III-IVB hypopharynx, stage III-IVB sinonasal, or stage III-IVB HPV- and/or p16-negative intermediate-high risk oropharynx head and neck cancer (AJCC 8th edition)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing different combinations of radiation and atezolizumab (a cancer drug) before and after surgery to see which is most effective in treating head and neck cancer.
Who is the study for?
Adults over 18 with certain advanced head and neck cancers (excluding HPV-related types) who can undergo radiation, atezolizumab treatment, and surgery. They must be in good health otherwise, not have had recent major surgeries or severe infections, and cannot be on immunosuppressive drugs or have a history of significant other diseases.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining radiotherapy with atezolizumab before surgical removal of the cancer. It aims to see how well patients do after this combined treatment followed by standard post-surgery care which may include chemotherapy.See study design
What are the potential side effects?
Atezolizumab might cause immune-related reactions affecting organs, fatigue, infusion reactions similar to allergic responses, liver issues, skin problems like rash or itching, hormone gland problems leading to changes in body functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication to boost it.
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My cancer is in the oral cavity, larynx, hypopharynx, sinonasal, or oropharynx and is stage II-IVB.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I weigh more than 30 kilograms.
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I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is above 40 mL/min.
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I am willing and able to follow the study's treatment plan and attend all visits.
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I have a tumor that can be measured and is larger than 10 mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I lead in: is Safety determined by Adverse Events
Phase II: Primary Endpoint is Efficacy as measured by the rate of MPR
Secondary outcome measures
Survival
Other outcome measures
Secondary Translational Endpoint
Translational Endpoints
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Creatinine increased
7%
Otitis externa
7%
Dehydration
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Blurred vision
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Hypertension
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: SBRT with Neoadjuvant AtezolizumabExperimental Treatment2 Interventions
Patients will undergo SBRT with atezolizumab neoadjuvantly followed by surgery and strictly risk-adjusted adjuvant treatment with radiation with or without chemotherapy according to national guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,480 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,097 Total Patients Enrolled
Sana KaramPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a severe infection or been hospitalized for one in the last 4 weeks.You are allergic to any of the study drugs or any of their ingredients.My blood thinner medication dose has been stable.I am not on any cancer treatments that aren't standard for head and neck cancer.I haven't taken strong immune-suppressing drugs in the last 14 days, except for low-dose steroids or inhalers.I have an autoimmune disease or immune deficiency, except for allowed conditions.I am post-menopausal or not pregnant if of childbearing potential.My white blood cell count is healthy without needing medication to boost it.I have or had lung inflammation that needed steroids.I am considered fit for surgery by an ENT surgeon and I am willing to undergo surgery.I haven't taken antibiotics for treatment in the last 2 weeks, but I may be on preventive antibiotics.I last received cancer treatment at least 30 days ago, or 6 weeks for specific drugs.I have not received a live vaccine within the last 4 months and do not plan to during or within 5 months after treatment.I have had lung conditions like pulmonary fibrosis, but not from radiation.My cancer is in the oral cavity, larynx, hypopharynx, sinonasal, or oropharynx and is stage II-IVB.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have had an organ or bone marrow transplant from another person.I do not have active infections like TB, hepatitis B/C, or HIV.I do not have any serious ongoing illnesses that could affect my participation in the study.I haven't had major heart problems or strokes in the last 3 months.I have had cancer before, but it was a different type than my current diagnosis.I do not need frequent procedures to remove excess fluid from my body.I am not pregnant or breastfeeding and willing to use effective birth control.My throat cancer is p16 positive.My cancer has spread to distant parts of my body.I am fully active and can carry on all my pre-disease activities without restriction.I weigh more than 30 kilograms.I am 18 years old or older.My organs and bone marrow are functioning well.My kidney function, measured by creatinine clearance, is above 40 mL/min.I am willing and able to follow the study's treatment plan and attend all visits.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have a tumor that can be measured and is larger than 10 mm.You have participated in another medical study using an experimental medication in the past 3 months.I have not taken drugs targeting immune checkpoints like PD-1 or CTLA-4.My cancer pain is managed and I've recovered from any recent radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: SBRT with Neoadjuvant Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has this treatment been studied before?
"Stereotactic Body Radiation Therapy has been under research scrutiny since 2008 when the first study was published by Hoffmann-La Roche. This initial study included 720 participants. After this Phase 2 trial, Stereotactic Body Radiation Therapy received drug approval in . There are currently 356 live studies being conducted across 1665 cities and 74 countries."
Answered by AI
Are there any available positions for trial participants?
"The online clinical trials database indicates that this study is looking for participants. The listing was created on November 2nd, 2021 and updated as recently as June 15th, 2022."
Answered by AI
What medical conditions are most often resolved with Stereotactic Body Radiation Therapy?
"Stereotactic Body Radiation Therapy can be used as a treatment for small cell lung cancer (sclc), malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
How many test subjects are a part of this clinical research?
"The listing on clinicaltrials.gov does show that this research is actively recruiting participants. The study was first advertised on November 2nd, 2021 and has since been edited June 15th, 2022. They are looking for 46 individuals at 4 different locations."
Answered by AI
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