Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 1NCT05376553
Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing Cemiplimab, Cisplatin and Docetaxel in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Krzysztof Misiukiewicz at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Cemiplimab, Cisplatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to Oct 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage III or IV, previously untreated, non-metastatic, locally advanced HNSCC (patients may have had previous surgery, but not chemotherapy or radiotherapy).
- 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.
- A pretreatment biopsy of the primary site sufficient for immune studies is required.
- Age >/= 18 years
- ECOG PS 0-1
- Hemoglobin > 8.0 g/dl, absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3
Show all 12Show fewer
- Predicted life expectancy >/= 12 weeks
- Total bilirubin <2.5 x Upper limit of normal (ULN); AST (SGOT) < 2.5 x ULN; ALT (SGPT) < 2.5 x ULN; serum creatinine </= 1.5 x ULN (Gilbert's disease allowed with elevated bilirubin)
- Patients must be accessible for repeat dosing and follow-up
- Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1
- Patients must provide verbal and written informed consent to participate in the study.
- A biopsy of the primary tumor or lymph node must be available for testing and immune evaluation
Who cannot join
- Locally advanced EBV positive nasopharyngeal cancer, malignancies other than SCC head and neck cancer except surgically treated malignancies that are not active (e.g. surgically treated thyroid cancer, prostate cancer, breast cancer etc.) for 3 years or more and no evidence of active recurrence.
- History of pneumonitis
- History of prior immunotherapy
- History of receiving PI3K inhibitors.
- Patients at 1.5mg or more a day of dexamethasone (or equivalent).
- History of significant cardiac disease unless the disease is well-controlled
Show all 25Show fewer
- Grade 2 peripheral neuropathy
- No excessive alcohol consumption will be allowed
- Serious comorbid illness, and involuntary weight loss of more than 20% of body weight in the 3 months preceding study entry
- History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
- Pregnant or breast-feeding females.
- GI abnormalities including inability to take oral medication, requirement for IV alimentation, active peptic ulcer, or prior surgical procedures affecting absorption
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
- Any type of active seizure disorder
- Patients with history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low- dose steroids, within 14 days prior to Day 1 dosing
- Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days
- Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study
- History of Hepatitis c or HIV infection, autoimmune disease (except vitiligo and Hashimoto's thyroiditis), or major organ transplant
- Any irradiation or chemotherapy in the past and no major surgical procedure in the last 4 weeks
- Any other concomitant anticancer therapies
- Patients will be excluded if they received any prior chemotherapy, radiotherapy, or treatment with biologic response modifiers (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
- History of colitis or chronic diarrheal illness
- History of, or active, co-morbid medical condition, which in the opinion of the investigator, would raise significant risk to the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Phase 1 Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
- Being tested
- Cemiplimab, Cisplatin, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
350mg intravenous infusion over 30 minutes
CisplatinDrug
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)
DocetaxelDrug
75 mg/2 intravenous infusion over 60 minutes, mixed as described in
Schedule: Day 1, every 21days (+ 2 days)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | * 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. Receives: Drug: Cemiplimab; Drug: Cisplatin; Drug: Docetaxel |
| Cohort B | Experimental | * 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. Receives: Drug: Cemiplimab; Drug: Cisplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 3 weeks of cemiplimab
Secondary outcomes (20)
Adverse events during induction therapy
Number of adverse events according to NCI CTCAE v4.0
Measured: At the end of Cycle 3 (each cycle is 21 days)
Blood Pressure
Measured: At the end of Cycle 3 (each cycle is 21 days)
Heart Rate
Measured: At the end of Cycle 3 (each cycle is 21 days)
Temperature
Measured: At the end of Cycle 3 (each cycle is 21 days)
Complete White Count (CBC)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Calcium
The calcium blood test measures the level of calcium in the blood.
Measured: 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.
Measured: 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.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Glucose
Measures the glucose levels in your blood.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start20 Jul 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krzysztof Misiukiewicz
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Krzysztof Misiukiewicz, Icahn School of Medicine at Mount Sinai
- Investigators
- Krzysztof Misiukiewicz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376553
- Sponsor's protocol ID
- STUDY-21-01683
- Status last verified
- Nov 2024
- First submitted
- 2 May 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT05376553
- Acronym / sponsor ID
- STUDY-21-01683
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Krzysztof MisiukiewiczUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Cemiplimab, Drug: Cisplatin, Drug: Docetaxel* 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. |
| Cohort B | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 pretreatment biopsy of the primary site sufficient for immune studies is required.
- Age >/= 18 years
- ECOG PS 0-1
- Hemoglobin > 8.0 g/dl, absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3
Key exclusion criteria (25 listed)
- Locally advanced EBV positive nasopharyngeal cancer, malignancies other than SCC head and neck cancer except surgically treated malignancies that are not active (e.g. surgically treated thyroid cancer, prostate cancer, breast cancer etc.) for 3 years or more and no evidence of active recurrence.
- History of pneumonitis
- History of prior immunotherapy
- History of receiving PI3K inhibitors.
- Patients at 1.5mg or more a day of dexamethasone (or equivalent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cemiplimab350mg intravenous infusion over 30 minutes | Drug | Cohort A, Cohort B |
| Cisplatin100mg/m² intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) | Drug | Cohort A, Cohort B |
| Docetaxel75 mg/2 intravenous infusion over 60 minutes, mixed as described in Schedule: Day 1, every 21days (+ 2 days) | Drug | Cohort A, Cohort B |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: During first cycle of cemiplimab (day 14)
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.
Dose-limiting toxicity (DLT)
Time frame: After 3 weeks of cemiplimab
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.
20 secondary outcomes
Adverse events during induction therapy
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
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Potassium
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Magnesium
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Bicarbonate (CO2)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Phosphate
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Calcium
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Blood Urea Nitrogen (BUN)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Uric Acid
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Glucose
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Lactate Dehydrogenase (LDH)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
SGOT (AST)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
SGPT (ALT)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Alkaline phosphatase (ALP)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Direct bilirubin
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Total bilirubin
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krzysztof Misiukiewicz, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemiplimab, Cisplatin and Docetaxel in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Krzysztof Misiukiewicz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: During first cycle of cemiplimab (day 14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.