EUCTR2015-005417-76-IT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) and Asian Pacific Association for the Study of the Liver (APASL)
- •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,
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
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
- •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.
- •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
- •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 study.
- •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 medication. Initiation or adjustment of
- •antihypertensive medication(s) is allowed prior to scree
研究者
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