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Monoclonal Antibodies
Cemiplimab + Chemotherapy for Head and Neck Cancer
Phase 1
Recruiting
Led By Krzysztof Misiukiewicz, MD
Research Sponsored by Krzysztof Misiukiewicz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A pretreatment biopsy of the primary site sufficient for immune studies is required
Patients with stage III or IV, previously untreated, non-metastatic, locally advanced HNSCC (patients may have had previous surgery, but not chemotherapy or radiotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of cycle 3 (each cycle is 21 days)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combo on patients with a specific type of head and neck cancer to see how safe and tolerable it is.
Who is the study for?
This trial is for adults over 18 with stage III or IV, previously untreated non-metastatic head and neck squamous cell carcinoma. Eligible patients may have had surgery but not chemotherapy or radiotherapy. They must be HPV negative or high-risk HPV positive, have a good performance status (ECOG PS 0-1), adequate organ function, and agree to use effective contraception. Exclusions include significant cardiac disease, psychiatric conditions affecting study compliance, severe allergies to docetaxel, active infections that could interfere with the study, history of certain diseases like colitis or autoimmune disorders (except vitiligo and Hashimoto's thyroiditis), prior immunotherapy treatment, and unstable brain metastases.Check my eligibility
What is being tested?
The trial tests two dosing schedules of cemiplimab in combination with cisplatin and docetaxel chemotherapy in patients with locally advanced head and neck cancer. Cemiplimab is approved for skin cancers but its safety for head and neck cancer is being studied here.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs; infusion-related reactions; fatigue; digestive issues like nausea; blood disorders including low counts of red cells, white cells or platelets which can increase infection risk; allergic responses especially if there's a known allergy to similar drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a biopsy of my cancer that can be used for immune studies.
Select...
I have stage III or IV head and neck cancer that hasn't been treated with chemo or radiotherapy.
Select...
I am 18 years old or older.
Select...
I can provide a biopsy sample from my tumor or lymph node for testing.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of cycle 3 (each cycle is 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of cycle 3 (each cycle is 21 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity (DLT)
Secondary outcome measures
Adverse events during induction therapy
Alkaline phosphatase (ALP)
Bicarbonate (CO2)
+17 moreSide 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
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment3 Interventions
In cohort B first dose of Cemiplimab will be given 7 days prior to TP followed by TP given on days 1,22,43 (+/- 2 days) and Cemiplimab given on days 14, 35, 56 (+/- 2 days).
Patient in cohort B will get 4 doses of Cemiplimab during induction therapy.
Group II: Cohort AExperimental Treatment3 Interventions
3 cycles of Cemiplimab-TP induction chemotherapy will be delivered in cohort A.
Cemiplimab-TP chemotherapy will be given every 21 days starting on days 1, 22 and 43, etc. (+ 2 days) with TP given on days 1, 22, and 43 (+/- 2 days) and Cemiplimab given on days 14, 35, 56 (+/- 2 days).
Patients in cohort A will get 3 doses of Cemiplimab during induction therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Krzysztof MisiukiewiczLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,441 Total Patients Enrolled
Krzysztof Misiukiewicz, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience moderate numbness, pain, or tingling in my hands or feet.I have not had a stroke or my stroke condition has been stable for the last 12 months.I am not on any other cancer treatments.I have a history of Hepatitis C, HIV, certain autoimmune diseases, or have had a major organ transplant.My cancer is in the mouth or throat and is either not caused by HPV or caused by a high-risk HPV type.I have an active seizure disorder.I have EBV positive nasopharyngeal cancer but no active cancer except possibly treated cancers with no signs of return for 3+ years.I have a history of chronic diarrhea or colitis.My heart condition is under control.I have had a biopsy of my cancer that can be used for immune studies.I have lost more than 20% of my weight in the last 3 months due to a serious illness.I have no GI issues that prevent me from taking pills or affect food absorption.I haven't taken strong medication that affects liver enzymes in the last 2 weeks.I have stage III or IV head and neck cancer that hasn't been treated with chemo or radiotherapy.I am 18 years old or older.I agree to use birth control during the study and can provide a negative pregnancy test if I'm a woman of childbearing age.I can provide a biopsy sample from my tumor or lymph node for testing.I have not had chemotherapy, radiotherapy, or biologic treatments for cancer, except for certain skin cancers or cervical pre-cancer.I have previously received immunotherapy.I have been treated with PI3K inhibitors before.I have had pneumonitis before.My brain cancer is causing symptoms, needs steroids, or was treated with radiation recently.I am taking 1.5mg or more of dexamethasone daily.I can attend all scheduled treatments and follow-up appointments.I haven't had radiation, chemotherapy, or major surgery in the last 4 weeks.I do not have any serious illnesses that could stop me from participating in the study.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
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 is the enrollment capacity of this clinical trial?
"Affirmative. According to clinicaltrials.gov, the medical trial that was initially posted on June 16th 2022 is currently recruiting participants. This study only requires 24 patients at a single site for completion."
Answered by AI
Is the recruitment for this research endeavor still open?
"Evidenced by clinicaltrials.gov, this medical trial is ongoing as of September 6th 2022 and it began recruiting on June 16th 2022."
Answered by AI
How has Cemiplimab been evaluated for safety among individuals?
"As this is a first-phase trial, there is limited information regarding the safety and efficacy of Cemiplimab. Thus, it receives an appraisal of 1 on our team's scale."
Answered by AI
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