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Checkpoint Inhibitor
SBRT + Immunotherapy for Head and Neck Squamous Cell Carcinoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the combination of two immunotherapy drugs, Durvalumab and Tremelimumab, with a type of radiation therapy called Stereotactic Body Radiotherapy (SBRT) to treat patients with metastatic head and neck squamous cell carcinomas. The goal is to assess the tolerability and efficacy of this combination in controlling cancer progression.
Who is the study for?
This trial is for adults with metastatic head and neck squamous cell carcinoma who have a good performance status, functioning organs, and marrow. They must not be pregnant or breastfeeding and agree to use birth control. Those with up to four prior systemic therapies are eligible but cannot have brain metastases, uncontrolled illnesses, or recent major surgeries.
What is being tested?
The study tests the combination of Durvalumab (MEDI4736) and Tremelimumab immunotherapies with SBRT (a precise radiation therapy). It aims to see if this combo can better control cancer progression in patients by using the body's immune system alongside targeted radiation.
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation of organs like lungs or intestines; plus those from radiotherapy like localized skin irritation and fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute toxicities of the treatment
Progression Free Survival (PFS)
Secondary study objectives
Abscopal events
Local control (LC)
Overall survival (OS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab + tremelimumab and SBRTExperimental Treatment3 Interventions
All subjects will receive durvalumab (1500 mg IV q4week) and tremelimumab (75mg q4week) for 4 doses, followed by durvalumab alone (1500 mg IV q4week) until disease progression, unacceptable toxicity or patient withdrawal. SBRT will be administered between cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Durvalumab
2017
Completed Phase 2
~3750
Tremelimumab
2017
Completed Phase 2
~3070
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,335 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,388 Previous Clinical Trials
289,109,060 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe, ongoing health issue that is not being managed or controlled.You have cancer that has spread to your brain or spinal cord.You have received a live vaccine within 30 days before the first dose of the study medication.If you are a woman who is pregnant or breastfeeding, or if you are a man or woman of reproductive age who is not willing to use effective birth control during the study.You cannot have received any cancer treatment within 30 days before starting the study drug.You are currently receiving any other type of treatment for cancer, such as chemotherapy, biologic therapy, or hormonal therapy.You have had an organ transplant from someone else in the past.You had cancer before, except in some cases.You have an allergic reaction or sensitivity to any of the study drugs or their ingredients.You are expected to live for at least 24 weeks.You have nasopharyngeal carcinoma.You have a history of lung disease, such as interstitial lung disease, which has been treated with steroids or is currently active.You have at least two measurable tumors outside of the brain that can be treated with SBRT (a type of radiation therapy).You have no more than 10 spread-out cancer growths in your body.You have a current or past history of autoimmune or inflammatory diseases.You can only participate if you have cancer that has spread to other parts of your body, even if you previously had cancer that only came back in the same area.A radiation oncologist has assessed you within 45 days before you joined the study.You saw an oncologist for a medical check-up within 45 days before enrolling in the study.You have been diagnosed with head and neck cancer that has spread to other parts of your body. The diagnosis can come from any accessible site and does not need to be from the time of initial diagnosis.You have at least two cancerous areas in your body that can be treated with SBRT (a type of targeted radiation therapy). If the cancerous areas are not big enough to be measured, they must have shown growth on two separate imaging tests, and be at least 5mm in size at the time of enrollment. Brain metastases are not included in this criterion.You have received four or fewer treatments for your condition using medication.You weigh more than 30 kilograms (about 66 pounds).You need to have a scan of your chest, abdomen, and pelvis, or a full body PET/CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + tremelimumab and SBRT
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.
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