EUCTR2018-003959-37-HU进行中（未招募）1 期
Phase IIa/IIb Clinical Trial of NC-6004 in Combination with Pembrolizumab in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen
anoCarrier Co, Ltd.0 个研究点目标入组 136 人开始时间: 2019年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Be willing and able to provide written informed consent for the trial.
- •2. Males or females aged =18 years at screening.
- •3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •4. Have histologically- or cytologically-confirmed HNSCC.
- •5. Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies
- •6. Must have received = 150mg/m2 of a total dose of cisplatin or 2 cycles of carboplatin AUC5 (maximum carboplatin dose per cycle 750mg)
- •7. Prior platinum failure as defined by
- •a. Disease progression confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST 1.1 criteria at any time during or after treatment with a platinum agent or a platinum-containing regimen for recurrent/metastatic disease
- •b. Recurrence/progression confirmed by CT or MRI imaging scans using RECIST 1.1 criteria < 6 months of prior modal therapy using a platinum agent or a platinum-containing regimen for locally advanced setting,
- •c. Recurrence/progression = 6 months of prior modal therapy in locally advanced HNSCC can be accepted only if subjects have received a further platinum containing regimen for recurrent and metastatic stage of disease and have progressed during or after this regimen.
- •8. Have a life expectancy of > 3 months
- •9. Have radiographically measurable disease based on RECIST 1.1
- •10. Have adequate bone marrow reserve, defined as:
- •a. Absolute neutrophil count = 1.5 × 109/L,
- •b. Platelet count = 100 × 109/L, and
- •c. Hemoglobin = 10 g/dL (transfusion is allowed to achieve = 10 g/dL)
- •11. Have adequate liver function, defined as
- •a. Total serum bilirubin = 1.5 × the upper limit of normal (ULN),
- •b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.0 × ULN or < 5.0 × ULN in case of documented hepatic metastasis
- •c. Serum albumin = 3.5 g/dL
- •12. Have prothrombin time within normal limits
- •13. Have adequate renal function, using the Cockcroft method: Glomerular filtration rate = 60 mL/min
- •14. Have results from central laboratory testing of HPV (defined as p16 IHC testing using CINtec p16 Histology assay and a 70% cutoff point)
- •15. Have provided tissue for PD-L1 biomarker analysis from a newly obtained core, excisional biopsy or an archived specimen. Repeat samples may be required if adequate tissue is not provided or for indeterminate results.
- •Note: If emerging data indicate a high concordance in PD-L1 expression scores between newly obtained and archival samples, archived samples may be acceptable.
- •16. Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. A urine test can be considered if a serum test is not appropriate.
- •17. Female subjects of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after
排除标准
- •1. Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, that originates from the skin, salivary gland or paranasal sinus, non-squamous histologies.
- •2. Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
- •3. Have more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.
- •4. Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
- •5. Have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks since the last dose of trial treatment the previous investigational agent or device
- •6. Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
- •7. Were diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma
- •8. Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or other immunosuppressive therapy within 7 days prior to 1st dose of trial treatment.
- •9. Subjects with a condition requiring systematic treatment with corticosteroids (> 10mg daily prednisone eqv.) within 14 days prior to 1st dose of study treatment.
- •10. Have had prior anti-cancer treatment or radiation therapy within 4 weeks prior to study Day 1 or who have not recovered (i.e., = Grade 1 or at baseline) from AEs due to previously administered treatment > 4 weeks earlier (i.e., monoclonal antibody [mAb], cetuximab, or any other cytotoxic drugs).
- •11. Had a prior allogenic organ or tissue transplant
- •12. Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •12. Have uncontrolled hypertension, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >130 mmHg under resting conditions.
- •13. Have peripheral sensory neuropathies (including hearing loss) and motor neuropathies >/= grade 2, in the opinion of the investigator
- •14.Have uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure >130 mmHg under resting conditions.
- •15.Have experienced any of the following within the 6-month period prior to screening: unstable angina pectoris, cerebrovascular accident, transient ischemic attack, uncontrolled congestive heart failure (New York Heart Association > class II) cardiac failure with known e
研究者
相似试验
进行中（未招募）
1 期
Clinical trial for patients with serious head and neck cancerHead and neck squamous cell carcinoma (HNSCC)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003959-37-PLanoCarrier Co, Ltd.136
进行中（未招募）
1 期
Clinical trial for patients with serious head and neck cancerHead and neck squamous cell carcinoma (HNSCC)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003959-37-CZanoCarrier Co, Ltd.136
进行中（未招募）
1 期
Treatment of Head&Neck CancerMetastatic squamous cell carcinoma of the head and neckMedDRA version: 20.0Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-000866-44-HUanoCarrier Co, Ltd80
进行中（未招募）
1 期
Treatment of Head&Neck CancerMetastatic squamous cell carcinoma of the head and neckMedDRA version: 20.0Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-000866-44-BGanoCarrier Co, Ltd80
进行中（未招募）
不适用
A single-arm Phase II clinical study of the combination of carboplatin and weekly paclitaxel plus bevacizumab as first-line treatment in patients with epithelial ovarian cancerEpithelial ovarian cancer, fallopian tube or primary peritoneal carcinomaMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancerMedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancerMedDRA version: 9.1Level: LLTClassification code 10061344Term: Peritoneal neoplasmEUCTR2008-008336-85-NLF. Hoffmann-La Roche Ltd.180