A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma

MedImmune, LLC0 个研究点目标入组 204 人开始时间: 2018年8月7日最近更新: 2019年1月7日

研究概览

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•1. Age = 18
•2. Written and signed informed consent must be obtained
•3. ECOG Performance Status 0 or 1
•4. Weight = 35 kg
•5. Subjects must have histologically or cytologically confirmed pancreatic adenocarcinoma:
•Cohort A: Subjects with previously untreated metastatic pancreatic adenocarcinoma (1 line metastatic disease) not previously treated with systemic therapies.
•Cohort B: Subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2 line metastatic adenocarcinoma
•6. Subjects must have at least 1 measurable lesion according to RECIST v1.1
•7. All subjects must consent to providing archival tumor specimens
•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 122
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 82

•1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
•2. Prior receipt of any immune-related therapy
•3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
•4. Subjects with a history of venous thrombosis within the past 3 months
•5. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
•6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
•7. Other invasive malignancy within 2 years.
•8. Any history of leptomeningeal disease or cord compression.
•9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose

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