A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.
详细描述
PRIMARY OBJECTIVE:
I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin.
SECONDARY OBJECTIVES:
I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially).
II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
- •No prior systemic therapy for treatment of R/M disease
- •Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
- •Must be at least four weeks since prior radiation and/or surgery
- •Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
- •At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
- •18 years of age and older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •White blood cell (WBC) count > 2,500 cells/uL
- •Absolute neutrophil count (ANC) >1,500 cells/uL
- •Platelet count >= 100,000 cells/uL
- •Hemoglobin >= 9 g/dL
- •Creatinine =< 1.6 mg/dL
- •Total bilirubin =< 1.6 mg/dL
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN)
- •Potassium >= lower limit of normal (LLN)
- •Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment
- •For female subjects with reproductive potential: a negative serum pregnancy test at baseline
- •Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule
排除标准
- •Disease amenable to curative local therapy
- •Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
- •Disease that requires corticosteroids or other ongoing immunosuppressive treatment
- •Previous treatment with mAb-based immunotherapy for treatment of prior oncologic treatment
- •Previous treatment with PI3K inhibitors
- •Known brain metastases, unless stable for at least 21 days prior to registration
- •Known infection human immunodeficiency virus (HIV), hepatitis B or C
- •Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
- •History of pneumonitis within the past five years
- •Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
- •Female patients who are pregnant or breast-feeding
- •Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator
研究组 & 干预措施
Treatment (cemiplimab, paclitaxel, carboplatin)
Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
干预措施: Cemiplimab (Biological)
Treatment (cemiplimab, paclitaxel, carboplatin)
Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
干预措施: Carboplatin (Drug)
Treatment (cemiplimab, paclitaxel, carboplatin)
Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 12 weeks
ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used.
次要结局
- Progression-free survival (PFS)(From the date of enrollment until documented disease progression, assessed up to 2 years)
- Overall survival (OS)(From the date of patient enrollment into the trial until death, assessed up to 2 years)
- Incidence of adverse events(Up to 24 weeks)
研究者
Marcelo Bonomi
Principal Investigator
Ohio State University Comprehensive Cancer Center