15 results
In order to set up paradigms for pharmaco-MRI studies for development of novel psychotropic medications. The present study will investigate the effect of: - low-dose benzodiazepine on brain activation and test performance on a testbed of well…
The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic…
Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…
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…
The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…
Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. • To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. Secondary…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…
We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-L1 expressing tumours (membranous staining in > 1%) who are at high…
Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…
Primary ObjectivePart A: To compare disease-free survival (DFS) per Blinded Independent Central Review (BICR) of nivolumab combined with ipilimumab versus placebo infusions in participants with localized RCC, with a predominantly clear cell…
Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had their stage IIB/C cancer completely removed, and have no evidence of disease, but are at high risk of recurrence.…
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for…
Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B participantsSecondary Objectives• To compare the overall survival (OS) in Arm A vs Arm B participants• To assess the…
Objectives of the studyPrimary ObjectiveTo compare recurrence-free survival (RFS)(based on BICR assessment) of nivolumab versus placebo in all randomized participants.Secondary Objectives• To compare overall survival (OS) of nivolumab versus placebo…