6 results
The study has two objectives. Firstly, we will investigate the safety and tolerability of the study drug following administration of a single escalating dose of the drug. Secondly, we will investigate the rate at which the study drug is absorbed…
Ultrasonography shows a niche at the site of the uterine caesarean scar in the majority of women with a CS in the past history. A niche is a triangular, anechoic area at the presumed site of incision. Our primary objective is to develop an…
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…
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…
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-…
The primary objective of this trial is:• Part 1 (dose-escalation): To evaluate the safety of BYON3521 and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE); • Part 2 (expansion): To evaluate the objective tumour…