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Tyrosine Kinase Inhibitor
Pembrolizumab + Cabozantinib for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Nabil F. Saba, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min within 7 days before the first dose of cabozantinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after treatment start
Awards & highlights
Study Summary
This trial is testing pembrolizumab + cabozantinib to treat head & neck squamous cell cancer that has returned or spread.
Who is the study for?
This trial is for adults with head and neck squamous cell cancer that's returned or spread and can't be surgically removed. They should have had some previous treatment, be in fairly good health (ECOG 0 or 1), not pregnant, willing to use contraception, and without certain medical conditions like major blood vessel invasion by the tumor or recent significant bleeding.Check my eligibility
What is being tested?
The study tests pembrolizumab (a monoclonal antibody) combined with cabozantinib (which blocks pathways for cell growth) on patients with advanced head and neck cancer. The goal is to see if this combination improves tumor response compared to what's currently available.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from pembrolizumab, as well as fatigue. Cabozantinib may cause high blood pressure, hand-foot syndrome (redness and pain in hands/feet), mouth sores, digestive issues, weight loss, and changes in hair color.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study requirements and have signed the consent form.
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My kidney function is within the required range for the treatment.
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I have squamous cell carcinoma in my head or neck area, or unknown primary but HPV positive.
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I have had only one radiotherapy session for my head or neck, whether for cure or relief.
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My hemoglobin level is at least 9 g/dL.
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I am not pregnant and can become pregnant.
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My lipase levels are normal and I haven't had pancreatitis recently.
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My liver tests are normal before starting cabozantinib.
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My kidney function test result is normal before starting cabozantinib.
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My cancer cannot be removed by surgery and has come back or spread.
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My white blood cell count is high enough for treatment.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after treatment start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after treatment start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Progression free survival (PFS)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, cabozantinib)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,453 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,515 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,503 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study requirements and have signed the consent form.My kidney function is within the required range for the treatment.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I have squamous cell carcinoma in my head or neck area, or unknown primary but HPV positive.I have had only one radiotherapy session for my head or neck, whether for cure or relief.I have recovered from side effects of previous treatments, with only mild symptoms remaining.I haven't had significant GI bleeding or coughed up blood recently.My hemoglobin level is at least 9 g/dL.My blood protein level is at least 2.8 g/dl.I am not pregnant and can become pregnant.I haven't had chemotherapy or biological treatment in the last 4 weeks.I have previously been treated with cabozantinib or pembrolizumab.I haven't taken any kinase inhibitor medication in the last 14 days.I am taking blood thinners or platelet inhibitors at treatment doses.My tumor is growing into or around major blood vessels.My lipase levels are normal and I haven't had pancreatitis recently.I agree to use birth control during and for 4 months after the study.You are expected to live for at least three more months.I had cancer before, was treated to cure it, and have been cancer-free for at least a year.My brain metastases are treated and stable for at least 4 weeks.My cancer has spread to my digestive system recently.I do not have any severe illnesses that are not under control.I have not had major surgery in the last 12 weeks.My liver tests are normal before starting cabozantinib.I cannot swallow pills or take pembrolizumab or cabozantinib.You have had an allergic reaction or are sensitive to any of the ingredients in the study treatment.My kidney function test result is normal before starting cabozantinib.My cancer cannot be removed by surgery and has come back or spread.My cancer is HPV negative and started in the lymph nodes of my neck.My bilirubin levels are within the normal range or slightly elevated.My white blood cell count is high enough for treatment.I am fully active or can carry out light work.All my cancer sites were checked within the last 28 days.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, cabozantinib)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab been sanctioned by the Federal Drug Administration?
"There is evidence that supports the safety of Pembrolizumab, so it was given a rating of 2. This clinical trail has reached its second phase but yet to prove efficacy."
Answered by AI
Are there any other documented experiments utilizing Pembrolizumab?
"Pembrolizumab is the focus of 1062 live studies, with 133 trials at Phase 3. There are a multitude of clinical trial sites across Houston and 42531 other locations around the country running these tests."
Answered by AI
What medical treatments is Pembrolizumab commonly prescribed for?
"Pembrolizumab is the preferred intervention for unresectable melanoma, and has also been observed to help manage microsatellite instability high, reduce recurrence risk in patients, and potentially ameliorate other diseases."
Answered by AI
What is the aggregate number of participants in this experiment?
"Affirmative. According to clinicaltrials.gov's data, this trial is enrolling patients at the moment and was first published on September 18th 2018. There are 53 vacancies split between two different medical sites that need to be filled by participants."
Answered by AI
Is recruitment currently taking place for this research endeavor?
"Affirmative, based on the information provided by clinicaltrials.gov this study is currently accepting patients. This research endeavour was initially published in September of 2018 and underwent its most recent update in February 2022. The researchers are recruiting a total of 53 individuals across two sites."
Answered by AI
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