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An Open-Label, Multicenter Phase Ib Study of The Safety and Efficacy of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab and/or Other Treatments in Patients With Solid Tumors
In this trial patients will be enrolled in 1 of 5 experimental treatment arms. In Arm A, patients with advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior treatment will receive atezolizumab and bevacizumab every three weeks, each cycle 21 days, as long as they are experiencing clinical benefit in the opinion of the investigator. In Arm B, patients with untreated HER2- adenocarcinoma of the stomach or gastroesophageal junction (GEJ) will receive atezolizumab, bevacizumab and FOLFOX chemotherapy every two weeks, each cycle of 28 days, as long as they are experiencing clinical benefit in the opinion of the investigator. Oxaliplatin will also be administered for up to 8 cycles. After 6 months, at the discretion of the investigator, capecitabine may be administered as a maintenance therapy without oxaliplatin, instead of infusional 5-FU and leucovorin, and biologic therapy may be given every 3 weeks. In Arm C, patients with untreated, metastatic pancreatic cancer will receive atezolizumab every 2 weeks, starting on day 1 of the first cycle (each cycle 28 days). Nab-paclitaxel and gemcitabine will be administered on days 1, 8 and 15 of each cycle at an interval of 3 weeks on/1 week off. Treatment may be continued as long as participants are experiencing clinical benefit in the opinion of the investigator. In Arm E, patients with metastatic esophageal cancer will be randomised (1:1) into Group E1 or Group E2. Patients with metastatic adenocarcinoma of esophageal carcinoma or GEJ Siewert Classification Type I will be automatically allocated into Group E3. Patients in Group E1 and Group E3 will receive the same treatment of atezolizumab and FOLFOX every 2 weeks (in a 28 day cycle), as long as clinical benefit is experienced. Oxaliplatin will also be administered for no more than 8 cycles. Patients in Group E2 receive atezolizumab followed by cisplatin and 5-FU q3w. Cisplatin will be administered for up to 6 cycles. In Arm F, patients with advanced or metastatic HCC who have had no prior therapy will be randomised (1:1) into Group F1 and Group F2. Patients in this arm will either receive atezolizumab alone (Group F2) or in combination with bevacizumab (Group F1) every 3 weeks, with dosing on the first day of each 21-day cycle. Patients in Group F2 will also be given the option to crossover to the combination therapy, provided they meet the proposed criteria.