The primary objective of this study is:
to evaluate the efficacy and safety of luspatercept for the treatment of anemia in subjects
with MPN-associated myelofibrosis with and without RBC-transfusion dependence.
To evaluate the efficacy of niraparib in combination with bevacizumab, as assessed by 18-month progression-free survival (PFS) landmark analysis, in patients with Stage IIIB to IV ovarian cancer who have complete response (CR), partial response (PR), or no evidence of disease (NED) following front-line, platinum-based chemotherapy with bevacizumab
Phase I part
To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001.
Phase II part
To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001
To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001
To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001
To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001
To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001
To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001
To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
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.
Determine the safety and tolerability, including Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose (RP2D) of PU-H71 in combination with ruxolitinib in subjects with PMF, post-PV MF, or post-ET MF with residual signs or symptoms of their disease despite at least 6 months treatment with ruxolitinib (Dose
Confirm the safety profile and RP2D of PU-H71 in combination with ruxolitinib in this patient population (Dose Confirmation).
Determine the pharmacokinetics (PK) of PU-H71 in combination with ruxolitinib under the conditions of this study.