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SBRT + Immunotherapy for Head and Neck Squamous Cell Carcinoma
Study 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.
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Squamous Cell Carcinoma
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Durvalumab + tremelimumab and SBRT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this research offer any available openings for participants?
"Based upon the information on clinicaltrials.gov, this particular trial is not presently recruiting patients. The experiment was originally posted in July of 2018 and last updated in November 2022; however, other studies are actively accepting participants at this time with a total of 3016 currently open to enrollment."
Have any additional studies explored the efficacy of Durvalumab?
"Presently, there are 340 separate clinical trials involving Durvalumab, including 52 Phase 3 studies. Although Cordoba, Texas is one of the leading locations for this drug's research and development, it can be found in over 13 thousand different sites around the world."
Is the current research endeavor a pioneering experiment?
"Currently, there are 340 ongoing trials of Durvalumab in 58 different nations and 1327 cities. This medication's clinical testing began in 2007 through a Phase 2 study funded by AstraZeneca that included 37 participants. Subsequently, 139 studies have been concluded since then."
How many participants is the trial accommodating?
"Unfortunately, this research project is no longer enrolling patients. It was first listed on July 17th 2018 and has not been updated since November 11th 2022. If you are searching for other studies related to oral squamous cell carcinoma, there are currently 2676 trials recruiting; 340 of them involve Durvalumab medication."
What objectives are this experiment hoping to accomplish?
"The main outcome measure that AstraZeneca will be evaluating over a three month period is Progression Free Survival (PFS). Moreover, this trial aims to assess secondary objectives such as PFS defined by RECIST v1.1 or death caused by any factor, Abscopal events described according to RECIST version 1.1., and Overall survival (OS) which takes into consideration the time from Day 1 of treatment with durvalumab and tremelimumab until date of death."
What indications is Durvalumab frequently administered for?
"Durvalumab has been approved as a treatment for individuals with unresectable stage III non-small cell lung cancer, metastatic ureter urothelial carcinoma and those who have not previously undertaken any treatments."
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