A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.

AstraZeneca0 个研究点目标入组 22 人开始时间: 2017年11月10日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. more than 18 years ( 20 years and more in Japan)
•2. Written informed consent
•3. Patients with histologically or cytologically documented chemotherapy-naive locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC.
•4. ECOG performance status of 0 or 1
•5. Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
•6. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
•7. No prior exposure to immune-mediated therapy
•8. Adequate organ and marrow function as defined below

•1. Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
•2. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment
•3. Any unresolved Grade more than 2 toxicity from previous anticancer therapy
•4. Active or prior documented autoimmune or inflammatory disorders
•5. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent
•6. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) more than 470 ms 20. Active tuberculosis
•7. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

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