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Checkpoint Inhibitor
Cemiplimab for Head and Neck Cancer
Phase 2
Recruiting
Led By Neil D Gross, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial gives patients cemiplimab before surgery to see if it will help treat their head and neck cancer that has come back and can be removed by surgery.
Who is the study for?
Adults with recurrent, surgically removable stage II-IV head and neck cutaneous squamous cell cancer are eligible for this trial. They must have acceptable organ function, no severe unresolved side effects from previous cancer treatments (except hair loss), and not be pregnant or breastfeeding. Participants should not have a history of certain diseases or conditions that could interfere with the study, including autoimmune diseases, serious infections, or recent receipt of live vaccines.Check my eligibility
What is being tested?
The trial is testing Cemiplimab's effectiveness when given before surgery to patients with specific types of skin cancer on the head and neck. Cemiplimab is an immunotherapy drug designed to boost the body's immune response against cancer cells by blocking a pathway tumors use to evade attack.See study design
What are the potential side effects?
Cemiplimab may cause side effects such as fatigue, skin reactions at the injection site, muscle pain, nausea, itching and rash. It can also lead to more serious issues like inflammation in organs which might present as pneumonitis (lung inflammation) or colitis (inflammation of the colon).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My skin cancer is in the head or neck area and is stage II-IV.
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My cancer hasn't spread far and can be measured.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Secondary outcome measures
Disease-free survival
Disease-specific survival
Overall survival
+2 moreOther outcome measures
Incidence of adverse events
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cemiplimab)Experimental Treatment1 Intervention
Patients receive cemiplimab IV over 30 minutes every 3 weeks. Cycles repeat every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,306 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,725 Total Patients Enrolled
Neil D Gross, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of certain infections.I have a history of certain types of cancer.I am fully active or restricted in physically strenuous activity but can do light work.I am taking bisphosphonates for high calcium levels due to cancer.I don't have any health issues that would prevent me from taking a new drug.I am currently taking or have taken drugs that affect my immune system.My side effects from previous cancer treatments are mild, except for hair loss.I am planning surgery as my main treatment, or I had surgery over 4 weeks ago and have recovered.I am 18 years old or older.My cancer can be measured by scans or physical exams.I am sexually active and not willing to use effective birth control.I have a specific skin condition.I have not taken certain medications or vaccines recently.My alkaline phosphatase levels are within normal limits, even with bone metastases.My skin cancer is in the head or neck area and is stage II-IV.My cancer hasn't spread far and can be measured.I have been treated with specific medications before.I have been treated with idelalisib before.I have a history of lung conditions.I haven't had cancer treatment in the last 3 weeks, except for certain allowed therapies.My kidney function, measured by creatinine levels or clearance, is within the required range.I have a specific blood cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cemiplimab)
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.
Has Cemiplimab been given the go-ahead by the FDA?
"Our group at Power has assigned the safety of Cemiplimab a score of 2 since this is only in its second trial phase. As such, there are data points attesting to its security but none that can confirm efficacy."
Answered by AI
Are there currently any opportunities to participate in this research endeavor?
"According to the clinicaltrials.gov website, this trial is actively recruiting patients. The initial post was made on July 3rd 2018 and has been updated as recently as October 12th 2022."
Answered by AI
What health applications does Cemiplimab typically address?
"Cemiplimab can be used to target alk gene mutations and is also effective in managing conditions such as malignancies, metastatic cutaneous squamous cell carcinoma, and end-of-life directives."
Answered by AI
How many participants are currently partaking in this research?
"Affirmative. Clinicaltrials.gov has evidence that this clinical trial, which was initially listed on July 3rd 2018 is actively recruiting subjects. The research requires 40 participants to be recruited from a single medical site."
Answered by AI
Have Cemiplimab's therapeutic properties been investigated in past research endeavors?
"Currently, 56 Cemiplimab medical trials are being conducted worldwide. Of those studies, 4 have advanced to Phase 3 of clinical testing. Most trails for this medication originate from Barcelona and California; however 1738 sites globally are running these experiments."
Answered by AI
What is the ultimate goal of this investigation?
"The primary outcome of this clinical trial, evaluated over a maximum duration of 6 weeks, is the Overall response rate. Secondary objectives include Patterns of failure assessed using summary statistics for continuous variables, Time to recurrence estimated with Kaplan and Meier methods and compared between subgroups via log-rank test, as well as Disease-specific survival gauged by frequency tables for categorical variables."
Answered by AI
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