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Pembrolizumab + Chemotherapy for Head and Neck Cancer
Study Summary
This trial will look at whether a new cancer drug is effective and safe for people with a certain type of cancer that has come back or spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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- I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My head or neck cancer can't be cured with surgery or radiation.I am a male willing to avoid donating sperm and use contraception or abstain from sex during and for 95 days after my treatment.I have cancer that has spread to my brain or spinal cord.I haven't had cancer in the last 5 years, except for certain skin cancers or early-stage cervical or breast cancer.I have a history of Hepatitis B or C.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.My condition can be treated with the goal of curing it.I have received an organ or tissue transplant from another person.I have or had lung inflammation not caused by infection and need steroids.I am currently being treated for an infection with medication.I have not had a live vaccine in the last 30 days.My doctor expects I have less than 3 months to live or my disease is quickly getting worse.My organs are functioning well.
- Group 1: Pembrolizumab + Carboplatin + Paclitaxel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the scope of enrollment for this medical research project?
"The study has closed enrollment, with the trial initially posted on October 27th 2020 and last updated May 9th 2022. Alternatively, there are presently 2677 studies recruiting for oral squamous cell carcinoma and 1989 trials involving Pembrolizumab that may be of interest to you."
What maladies can be managed effectively with Pembrolizumab?
"Pembrolizumab is commonly deployed to combat malignant neoplasms but can also be used to treat unresectable melanoma, microsatellite instability high, and cases of heightened recurrence risk."
Does this research project accept participants beyond the age of 25?
"To be considered for this research, a patient must fall between 18 and 120 years of age. This is an exclusive criteria; as such, there are 183 studies available to those under the legal age of consent and 4576 for elders above 65."
Does the usage of Pembrolizumab present any considerable risk to patients?
"There is ample evidence that pembrolizumab is safe, so it obtained a rating of 3."
Are there any remaining slots available for participating in this clinical experiment?
"This study, which was first posted on October 27th 2020 and last updated 9th May 2022 is not currently recruiting. Nevertheless, there are numerous other trials searching for volunteers right now - 4666 in total."
How many sites have been approved to administer this research project?
"This trial is enrolling participants at a variety of medical centres, such as Orlando Health, Inc. in Orlando (Site 0216), Abington Hospital - Asplundh Cancer Center ( Site 0229) in Willow Grove and Princess Margaret Cancer Centre ( Site 0005), located in Toronto. Additionally, there are 16 other locations recruiting patients for this study."
Could you please elucidate the other experiments which have taken place with Pembrolizumab?
"As of now, there are 1,989 distinct clinical trials that involve Pembrolizumab with 413 being in the third phase. The majority of these studies originate from Shanghai yet additional research sites amounting to 91,495 have been set up worldwide for this medication's evaluation."
What qualifications must a person meet to be enrolled in this experiment?
"This trial requires 100 individuals with oral squamous cell carcinoma, aged between 18 and 120 years of age. Furthermore, the participants should be histologically or cytologically-confirmed to not be curable through local therapies; male partakers must abstain from sperm donation plus heterosexual intercourse while utilizing contraception during intervention period and for 95 days after carboplatin/paclitaxel; female applicants cannot be pregnant nor breastfeeding and can either not have fertility potentials or use highly effective contraceptives throughout the intervention duration as well as 30 days post paclitaxel intake or 6 months after carboplatin usage (whichever is later) whilst also committing"
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