A Phase 1 interventional study of Cemiplimab and Cisplatin in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Krzysztof Misiukiewicz. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Krzysztof Misiukiewicz · Phase 1, Interventional, and Treatment
The purpose of this research study is to determine the safety and tolerability of two dosing schedules of cemiplimab given in combination with cisplatin and docetaxel induction chemotherapy (TPI) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Cemiplimab is FDA approved for treatment of basal cell and squamous cell carcinoma of the skin as well as non-small cell lung cancer but not for squamous cell carcinoma of head and neck.
Krzysztof Misiukiewicz is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Patients with stage III or IV, previously untreated, non-metastatic, locally advanced HNSCC (patients may have had previous surgery, but not chemotherapy or radiotherapy).
a) Patients with oral cancer, HPV negative oropharyngeal cancer, high risk HPV+ oropharyngeal HNSCC confirmed by PCR. Patients with unknown primary, supraglottic, nasopharyngeal, and hypopharyngeal SCC will be allowed. High risk HPV defined as one of the following: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82.
Exclusion Criteria:
* 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.
Drug: Cemiplimab · Drug: Cisplatin · Drug: Docetaxel
* 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.
Drug: Cemiplimab · Drug: Cisplatin · Drug: Docetaxel
350mg intravenous infusion over 30 minutes
100mg/m² intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
75 mg/2 intravenous infusion over 60 minutes, mixed as described in Schedule: Day 1, every 21days (+ 2 days)
Dose-limiting toxicity (DLT)
The dose-limiting toxicity (DLT) will be the basis for safety and toxicity of Cemiplimab -TP that will be measured and reported only during the first cycle of Cemiplimab -TP for the first 6 study objects in each cohort A and B since the majority of the DLT occurs after the first treatment cycle in multiple phase I oncology clinical trials. DLTs must be related to a study drug, cemiplimab. Known and expected chemotherapy (TP, standard of care) adverse events not related to cemiplimab will not be defined as DLTs.
Time frame: During first cycle of cemiplimab (day 14)
Dose-limiting toxicity (DLT)
The dose-limiting toxicity (DLT) will be the basis for safety and toxicity of Cemiplimab -TP that will be measured and reported only during the first cycle of Cemiplimab -TP for the first 6 study objects in each cohort A and B since the majority of the DLT occurs after the first treatment cycle in multiple phase I oncology clinical trials. DLTs must be related to a study drug, cemiplimab. Known and expected chemotherapy (TP, standard of care) adverse events not related to cemiplimab will not be defined as DLTs.
Time frame: After 3 weeks of cemiplimab
Adverse events during induction therapy
Number of adverse events according to NCI CTCAE v4.0
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Blood Pressure
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Heart Rate
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Temperature
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Complete White Count (CBC)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Sodium
A sodium blood test measures the amount of sodium in the blood. Sodium is a type of electrolyte. Electrolytes are electrically charged minerals that help maintain fluid levels and the balance of chemicals in the body called acids and bases. Sodium also helps the nerves and muscles work properly.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Potassium
A potassium blood test measures the amount of potassium in the blood. Potassium is a type of electrolyte. Electrolytes are electrically charged minerals in the body that help control muscle and nerve activity, maintain fluid levels, and perform other important functions. The body needs potassium to help the heart and muscles work properly.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Magnesium
A magnesium blood test measures the amount of magnesium in the blood. Magnesium is a type of electrolyte. Electrolytes are electrically charged minerals that are responsible for many important functions and processes in the body.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Bicarbonate (CO2)
test to measures the amount of carbon dioxide in the liquid part of your blood, called the serum. The CO2 test is most often done as part of an electrolyte or basic metabolic panel. Changes in the CO2 level may suggest that the body is losing or retaining fluid.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Phosphate
A phosphate in blood test measures the amount of phosphate in the blood. Phosphate is an electrically charged particle that contains the mineral phosphorus. Phosphorus works together with the mineral calcium to build strong bones and teeth.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Calcium
The calcium blood test measures the level of calcium in the blood.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Blood Urea Nitrogen (BUN)
Urea nitrogen is what forms when protein breaks down. This test measures the amount of urea nitrogen in the blood.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Uric Acid
Uric acid is a chemical created when the body breaks down substances called purines. Most uric acid dissolves in blood and travels to the kidneys. From there, it passes out in urine. This test checks to see how much uric acid is in the blood.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Glucose
Measures the glucose levels in your blood.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Lactate Dehydrogenase (LDH)
This test measures the level of lactate dehydrogenase (LDH), also known as lactic acid dehydrogenase, in the blood or sometimes in other body fluids. If the LDH blood or fluid levels are high, it may mean certain tissues in the body have been damaged by disease or injury.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
SGOT (AST)
Aspartate aminotransferase (AST) blood test measures the level of the enzyme AST in the blood.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
SGPT (ALT)
The alanine transaminase (ALT) blood test measures the level of the enzyme ALT in the blood. ALT is an enzyme found in a high level in the liver. An enzyme is a protein that causes a specific chemical change in the body.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Alkaline phosphatase (ALP)
Alkaline phosphatase (ALP) is a protein found in all body tissues. Tissues with higher amounts of ALP include the liver, bile ducts, and bone. A blood test can be done to measure the level of ALP.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Direct bilirubin
The bilirubin blood test measures the level of bilirubin in the blood. Bilirubin is a yellowish pigment found in bile, a fluid made by the liver.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Total bilirubin
The bilirubin blood test measures the level of bilirubin in the blood. Bilirubin is a yellowish pigment found in bile, a fluid made by the liver.
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Immediately following publication. No end date.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Oct 2025, 39 months after the start.
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Studies of the drug tested here: Cemiplimab
Krzysztof Misiukiewicz