5 results
4.1 Primary Objective• To determine the MTD and to establish the safety profile of enapotamab vedotin in a mixed population of patients with specified solid tumors. 4.2 Secondary Objectives• To evaluate the safety laboratory parameters of enapotamab…
Primary:* To assess the safety and tolerability of LAM-001 administered daily by dry powder inhaler (DPI) for 14 days in patients with lymphangioleiomyomatosis (LAM) (Period 1).* To assess the longer-term safety and tolerability of LAM-001…
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-…