KCT0004505Recruiting未知
Biomarker-oriented study of Durvalumab(MEDI4736)/Tremelimumab in combination with gemcitabine/cisplatin in chemotherapy –naïve biliary tract cancer
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 135
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 18(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1.Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2.Age > 18 years at time of study entry or Adult male or female (according to age of majority as defined as =18 years)
- •3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4.Histologically proven biliary tract cancer including intrahepatic cholangiocarcionoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
- •5.Unresectable or recurrent
- •6.Chemotherapy-naïve for their unresectable or recurrent cancer (Previous expose to adjuvant chemotherapy is allowed)
- •7.Should have measurable lesion based on RECIST V1.1
- •8.Without previous expose to immune-oncology agents including anti-CTLA4, anti-PD1, anti-PDL1, etc
- •9.Life expectancy of > 12 weeks
- •10.Adequate normal organ and marrow function as defined below:
- •?Haemoglobin = 9.0 g/dL
- •?Absolute neutrophil count (ANC) = 1.5 x 109/L (> 1500 per mm3)
- •?Platelet count = 100 x 109/L (>100,000 per mm3)
- •?Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). <<This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.>>
- •?AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be = 5x ULN
- •?Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- •11.Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: =60 years old and no menses for ?1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- •12.Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion Criteria
- •1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)Previous enrollment in the present study
- •2.Participation in another clinical study with an investigational product during the last 3 weeks
- •3.Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab
- •4.History of another primary malignancy except for:
- •Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low potential risk for recurrence
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ
- •5.Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
- •6.Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction
- •7.Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- •8.Any unresolved toxicity (>CTCAE grade <<2>>) from previous anti-cancer therapy.
- •9.Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •10.Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •11.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- •12.History of primary immunodeficiency
- •13.History of allogeneic organ transplant
- •14.History of hypersensitivity to durvalumab or any excipient
- •15.History of hypersensitivity to the combination or comparator agent
- •16.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- •17.Known history of previous clinical diagnosis of tuberculosis
- •18.History of leptomeningeal carcinomatosis
- •19.Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
- •20.Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •21.Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- •22.Symptomatic or uncontrolled brain metastases requiring concurrent treatment,
Investigators
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