6 results
Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
To compare PFS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria.To compare OS of subjects with newly-…
Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
Primary:To determine the efficacy (as defined by progression-free survival [PFS]) of nirogacestat in adult participants with progressing DT/AF.Secondary:To evaluate the safety and tolerability of nirogacestat in adult participants with progressing…