EUCTR2015-005417-76-DE进行中（未招募）1 期
A phase Ib/II, open-label, multi-center study of INC280 in combination with PDR001 or PDR001 single agent in advanced hepatocellular carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1. Histologically or cytologically documented locally advanced recurrent or metastatic HCC or for patients with cirrhosis clinical diagnosis of HCC according to the American Association for the Study of Liver Diseases (AASLD) criteria. Current cirrhotic status of Child Pugh Class A (5-6
- •points), with no encephalopathy and/or clinically significant ascites (defined as requiring diuretics or paracentesis treatment). Child Pugh status must be calculated based on clinical and laboratory results during the screening period.
- •2. Baseline tumor tissue (newly obtained) must be available at screening. Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines and requirements for such procedure.
- •3. Patients must be willing to undergo a new tumor biopsy during the study (6-9 weeks after start of study treatment, if medically feasible). For patients in the phase II part of the study, exceptions may be granted after documented discussion with Novartis. After a sufficient number of paired biopsies are collected, the decision may be taken to stop collecting the biopsies.
- •4. Patients must have received prior sorafenib treatment for HCC with documented progression during or after discontinuation of sorafenib treatment (for France only: patients must have received at least 8 weeks of prior sorafenib treatment), or are intolerant to sorafenib (defined as documented Grade 3 or 4 adverse events that led to sorafenib discontinuation).
- •5. Patients must be tested during screening for Hepatitis-B-Virus surface antigen (HbsAg) status. Patients are included in the study if they have adequately controlled hepatitis B, defined by:
- •receiving a nucleoside analog anti-viral drug for 3 or more months, and
- •serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than 100 IU/ml via polymerase chain reaction quantification assays prior to enrollment.
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Patient has received the following therapies prior to the first dose of study treatment:
- •Previous systemic anti-cancer therapy (including therapeutic cancer vaccines and immunotherapeutics) other than sorafenib (sorafenib must be completed within > 2 weeks prior to the first dose of study treatment) or INC280.
- •Previous locoregional therapy (e.g. hepatic arterial embolization, radio-frequency ablation, radiation therapy) if:
- •- administered after sorafenib treatment with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain. Loco regional therapy for the focally painful liver tumor mass will be discussed on a case by case with Novartis.
- •- completed within 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
- •2. Use of any live vaccines within 4 weeks of initiation of study treatment.
- •3. Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
- •4. Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment, unless agreed otherwise with Novartis.
- •5. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities or daily living or requiring therapeutic intervention).
- •6. Presence of CTCAE grade =1 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE grade = 3) due to prior cancer therapy, unless agreed otherwise with Novartis.
- •to prior cancer therapy, unless agreed otherwise with Novartis.
- •7. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF) = 2 weeks prior start or study drug. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is on a stable dose.
- •8. History of severe hypersensitivity reactions to other mAbs.
- •9. Positive human immunodeficiency (HIV) testing at screening or Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •10. Clinically significant pleural effusion that either required pleurocentesis or is associated with shortness of breath.
- •11. Patients receiving treatment with medications that are strong inducers of CYP3A4 and that cannot be discontinued at least 1 week prior to the start of treatment with INC280 and for the duration of the
- •12. Unable to stop herbal/food supplements or treatments which are considered to be capable of significantly causing either PK or PD herb/food-drug interactions.
- •13. Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids or any immunosuppressive therapy, except vitiligo or resolved asthma/atopy that is treated with bronchodilators (e.g., albuterol).
- •14. Clinically significant, uncontrolled heart diseases.
- •Unstable angina within 6 months prior to screening
- •Myocardial infarction within 6 months prior to screening
- •History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- •Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) = 160 mm Hg and/or Diastolic Blood Pressure (DBP) = 100 mm Hg, with or without antihypertensive medic
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