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PD-1 Inhibitor
Pembrolizumab + Anti-platelet Therapy for Head and Neck Cancer
Phase 1
Recruiting
Led By John Kaczmar, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has adequate renal function, defined as estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula
Subject has pathologic confirmation of recurrent or metastatic HNSCC, regardless of HPV status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining two existing therapies in the hopes of creating a more favorable immunologic response in patients with a specific type of head and neck cancer.
Who is the study for?
Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that expresses PD-L1 or has progressed after chemotherapy can join. They must have a life expectancy of at least 3 months, measurable disease, good performance status, and adequate organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if combining Pembrolizumab (an immunotherapy drug) with anti-platelet drugs like acetylsalicylic acid and Clopidogrel improves immune response in patients compared to just using immunotherapy alone.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, bleeding due to anti-platelet therapy, fatigue from Pembrolizumab, as well as potential liver or kidney issues related to the body's reaction to these medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys work well enough, with a creatinine clearance over 30 mL/min.
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My cancer has returned or spread and it's confirmed by tests.
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My liver is functioning well, based on recent tests.
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I can take care of myself and am up and about more than half of my waking hours.
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My tumor is PD-L1 positive or my cancer worsened after platinum chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of Pembro + antiplatelet on major cellular parameters
Secondary outcome measures
Effect of Pembro + antiplatelets on immunologic markers
Frequency of adverse events reported
Tumor response rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment3 Interventions
Group 2 will be treated with Regimen B, followed by Regimen A. Regimen B is pembrolizumab alone for 6 weeks. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks.
Group II: Group 1Experimental Treatment3 Interventions
Group 1 will be treated with Regimen A, followed by Regimen B. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks. Regimen B is pembrolizumab alone for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
acetylsalicylic acid
2016
Completed Phase 4
~2190
Clopidogrel
2010
Completed Phase 4
~9160
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,615 Total Patients Enrolled
John Kaczmar, MDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that could affect my treatment.I have not received any vaccines within 4 weeks before starting pembrolizumab, except for inactivated ones.I am on blood thinners but can stop them for 7 days.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I am 18 years old or older.I need another round of radiation therapy to my head or neck.My head or neck cancer is affecting my carotid artery or its branches.I have a draining wound or fistula in my head or neck area.I have an aneurysm in my head or neck from surgery.I am allergic to aspirin or NSAIDs but can stop taking them for 7 days.I currently have a stomach or intestinal ulcer.I have a condition that causes excessive bleeding.I have a serious heart condition.My cancer can be measured and has grown in areas previously treated with radiation.I am not pregnant or nursing.My cancer has returned or spread and it's confirmed by tests.I am not on any immunosuppressive treatments or cancer therapies within the last 14 days.I had major surgery less than 4 weeks ago.I have a condition that causes me to bleed easily.I agree to use effective birth control during and up to 120 days after the study.I have taken a pregnancy test in the last 14 days and it was negative.My liver is functioning well, based on recent tests.I can take care of myself and am up and about more than half of my waking hours.My tumor is PD-L1 positive or my cancer worsened after platinum chemotherapy.I have received an organ transplant.My brain metastases are stable and I haven't needed specific treatment or steroids for them in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
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.
What potential harms may arise from Pembrolizumab usage?
"The low amount of available data on pembrolizumab's efficacy and safety resulted in a score of 1 being assigned to the drug."
Answered by AI
How many human participants are being observed for this clinical investigation?
"Affirmative, the available data on clinicaltrials.gov reveals that this research endeavor is currently recruiting participants. Initially posted on October 20th 2017, it seeks to enrol 20 patients from a single location."
Answered by AI
Has this research project started accepting participants yet?
"This clinical trial, which was published in October 2017, is still actively seeking participants. The details have been recently updated on March 31st 2022 according to the information provided by clinicaltrials.gov."
Answered by AI
What evidence exists to support the efficacy of Pembrolizumab?
"Presently, 1151 trials are conducted regarding the effectiveness of Pembrolizumab. Out those active studies, 175 have moved past Phase 2 and into the third phase of investigation. These medical experiments can be found across 39737 different locations globally with a concentration in Cleveland, Ohio."
Answered by AI
What medical applications commonly utilize Pembrolizumab?
"As a therapeutic option, pembrolizumab can be used to address bursitis as well as other ailments such as melanoma, metastatic cutaneous squamous cell carcinoma, and cardiovascular disorders."
Answered by AI
Is this research an unprecedented discovery?
"To date, 1151 clinical trials concerning the effectiveness of pembrolizumab are active across 3313 cities and 75 nations. Abbott first initiated an experiment with 15480 participants in 2005, leading to its Phase 4 drug approval stage; yet since then 982 more studies have been completed."
Answered by AI
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