NCT04831450撤回2 期
Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.
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
- •Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •Intermediate or high-risk disease defined by the following:
- •Squamous Cell Carcinoma of the oral cavity, larynx or hypopharynx American Joint Committee on Cancer (AJCC) 8th Stage III-IVB
- •p16-Negative oropharynx SCC, AJCC 8th Stage III-IVB
- •p16--positive oropharyngeal SCC, AJCC 8th stage II-III
- •Tumor must have documented Programmed Death (PD) Ligand (L) -1 Combined Positive Score (CPS) PD-L1 CPS ≥ 1 by immunohistochemistry (IHC).
- •Prior therapy for advanced stage HNSCC with definitive Standard of Care (SoC) CRT Intensity Modulated Radiation Therapy (IMRT (66-70 Gy) with concurrent Cisplatin with curative intent. Patients must have received a total cumulative dose of cisplatin of ≥ 200 mg/m2 or equivalent carboplatin plus taxanes combination per investigator criteria during concurrent treatment.
- •No clinical or radiographic evidence of progressive disease at the time of enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤
- •Adequate bone marrow function, including:
- •Absolute Neutrophil Count (ANC) ≥ 1,000/µL or ≥ 1.0 x 10^9/L.
- •Platelets ≥ 75,000/µL or ≥ 100 x 10^9/L.
- •Hemoglobin ≥ 8 g/dL (may have been transfused).
- •Adequate renal function, as determined by an estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft- Gault.
- •Adequate liver function, including:
- •Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •Aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN.
- •Pregnancy test (for patients of childbearing potential) negative at screening.
- •Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two methods of contraception (at least one of which is considered to be highly effective throughout the study and for at least 3 months after the last dose of cemiplimab-rwlc.
- •Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative, as allowed by local guideline/practice) has been informed of all pertinent aspects of the study.
排除标准
- •Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T lymphocyte Associated (CTLA)-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
- •Major surgery ≤ 4 weeks prior to enrollment.
- •Prior malignancy (other than the current Head and Neck cancer or in situ disease) requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score ≤6) either curatively treated or deemed to not require treatment, ductal in situ carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
- •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •Active infection requiring systemic therapy.
- •Use of immunosuppressive medication at time of enrollment, except the following:
- •Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent
- •Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- •Prior organ transplantation including allogenic stem-cell transplantation.
- •Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
- •Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA [ribonucleic acid] if anti-HCV antibody screening test positive).
- •Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 methods of contraception (at least one of which is considered to be highly effective) for at least 3 months after the last dose of cemiplimab-rwlc.
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
Cemiplimab After CRT in HNSCC
Experimental
Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
干预措施: Cemiplimab-Rwlc (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 2 years
Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
次要结局
- Incidence of Treatment-Related Toxicity and Adverse Events(Up to 9 months)
- PFS Rate(Up to 1 year)
- Overall Survival (OS)(Up to 2 years)
研究者
Chukwuemeka Ikpeazu
Associate Professor of Clinical
University of Miami
相似试验
招募中
1 期
Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell CarcinomaCutaneous Squamous Cell CarcinomaMerkel Cell CarcinomaNCT04975152H. Lee Moffitt Cancer Center and Research Institute36
进行中（未招募）
2 期
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and NeckMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown PrimaryNCT04862650Marcelo Bonomi46
终止
2 期
Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCCCutaneous Squamous Cell CarcinomaCutaneous Squamous Cell Carcinoma of the Head and NeckNCT04242173H. Lee Moffitt Cancer Center and Research Institute3
撤回
2 期
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)Cutaneous Squamous Cell CarcinomaNCT06384820Regeneron Pharmaceuticals
已完成
2 期
Evaluation of Pembrolizumab in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic CyclophosphamideMetastatic Breast CancerNCT03139851Centre Leon Berard36