NCT05376553Enrolling By Invitation1 期
Phase 1 Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Krzysztof Misiukiewicz1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Cemiplimab (Drug)
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.
干预措施: Cisplatin (Drug)
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.
干预措施: Docetaxel (Drug)
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.
干预措施: Cemiplimab (Drug)
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.
干预措施: Cisplatin (Drug)
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.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 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.
次要结局
- Temperature(At the end of Cycle 3 (each cycle is 21 days))
- Blood Pressure(At the end of Cycle 3 (each cycle is 21 days))
- Adverse events during induction therapy(At the end of Cycle 3 (each cycle is 21 days))
- Heart Rate(At the end of Cycle 3 (each cycle is 21 days))
- Complete White Count (CBC)(At the end of Cycle 3 (each cycle is 21 days))
- Sodium(At the end of Cycle 3 (each cycle is 21 days))
- Bicarbonate (CO2)(At the end of Cycle 3 (each cycle is 21 days))
- Calcium(At the end of Cycle 3 (each cycle is 21 days))
- Uric Acid(At the end of Cycle 3 (each cycle is 21 days))
- Lactate Dehydrogenase (LDH)(At the end of Cycle 3 (each cycle is 21 days))
- Alkaline phosphatase (ALP)(At the end of Cycle 3 (each cycle is 21 days))
- Potassium(At the end of Cycle 3 (each cycle is 21 days))
- Magnesium(At the end of Cycle 3 (each cycle is 21 days))
- Phosphate(At the end of Cycle 3 (each cycle is 21 days))
- Blood Urea Nitrogen (BUN)(At the end of Cycle 3 (each cycle is 21 days))
- Glucose(At the end of Cycle 3 (each cycle is 21 days))
- SGOT (AST)(At the end of Cycle 3 (each cycle is 21 days))
- SGPT (ALT)(At the end of Cycle 3 (each cycle is 21 days))
- Direct bilirubin(At the end of Cycle 3 (each cycle is 21 days))
- Total bilirubin(At the end of Cycle 3 (each cycle is 21 days))
研究者
Krzysztof Misiukiewicz
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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