Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with
PDR001 (and as single agent if appropriate) in patients with advanced solid tumors.
Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in
combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when
BLZ945 is administered in combination with PDR001.
Primary Outcome Measures:
The percentage of patients who are alive without disease progression
Assess the percentage of patients without disease progression based on local investigator assessment per RECIST in cohort A and cohort B
To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy.
To evaluate the incidence of Event-Free Survival at 12 months, where Event-Free Survival is defined as High-Grade-Recurrence Free Survival
Primary Objective: To compare DFS as assessed by the investigator for participants treated with pembrolizumab versus those receiving placebo
Hypothesis: Pembrolizumab is superior to placebo with respect to DFS.
Secondary Objective: To compare OS for participants treated with pembrolizumab versus those receiving placebo
Hypothesis: Pembrolizumab is superior to placebo with respect to OS