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Pembrolizumab + Radiation for Head and Neck Cancer
Study Summary
This trial is testing a new cancer treatment combination for people with head and neck cancer who can't have standard treatment.
- Head and Neck Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- You have another type of cancer that has spread, is getting worse, or needs ongoing treatment.You have a history of lung inflammation that needed treatment with steroids, or you currently have lung inflammation.
- Group 1: Radiation
- Group 2: Open label
- 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
Is the enrollment of geriatric patients part of this research experiment?
"The parameters for qualification to this clinical trial state that participants must be 18-99 years old. Furthermore, 46 studies are available for minors and 1434 trials exist for those over the age of 65."
Has Pembrolizumab obtained the necessary regulatory approval from the FDA?
"Our team at Power assigned Pembrolizumab a safety rating of 2. This is because while phase two trials offer assurance on the drug's security, there are no extant data supporting its effectiveness."
What therapeutic indications is Pembrolizumab typically utilized for?
"Pembrolizumab is mostly used to treat malignant tumours, but can also be useful in managing unresectable melanoma, microsatellite instability high (MSI-H), and cases of disease progression after chemotherapy."
What is the scope of recruitment for this trial?
"This trial is no longer accepting patients, as its initial posting was on May 16th 2016 and it received a final edit December 6th 2021. If one is seeking to join other trials related to head and neck cancer, there are 481 studies available at present; for Pembrolizumab specifically, 961 additional experiments currently have open enrollment."
Is this trial actively recruiting participants?
"This trial is not currently enrolling patients. According to clinicaltrials.gov, the original posting date was May 16th 2016 and it has been updated most recently on December 6th 2021; although this study does not require any volunteers right now, there are 1442 other clinical trials that do need participants at present."
Is it possible for me to participate in this trial?
"This clinical trial seeks 29 patients aged 18 to 99 who have been diagnosed with head and neck cancer. Participants must meet the following criteria: histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck according to American Joint Committee on Cancer standards, Eastern Cooperative Oncology Group Performance Status no higher than 1, sufficient bodily organ functionality as evidenced by lab tests conducted within 2 weeks of beginning treatment for males an adequate form of contraception is necessary from first dose through 4 months after last does; females should abstain from heterosexual activity during study period, negative pregnancy test for women"
Could you enumerate the clinical trials previously conducted with Pembrolizumab?
"Currently, there are 961 active investigations for the efficacy of Pembrolizumab with 122 studies in Phase 3. In Houston Texas alone, several trials have been conducted; however, globally over 35 thousand sites offer research opportunities regarding this drug."
What beneficial results are expected from this clinical experiment?
"According to the clinical trial sponsor, Merck Sharp & Dohme LLC., the primary objective of this study is 20 Week Progression Free Survival Rate and it will be tracked over a 12 month period from Day 1. Additionally, secondary objectives such as Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) score range between 0-4 rating function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional wellbeing(FWB). The HNC subscale has additionally an additional 12 items"
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