26 results
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…
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…
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…
To assess the difference in efficacy between two ultra-low doses (1 x 500 mg and 1 x 200 mg) and standard low dose (1 x 1000 mg) of RTX retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6…
The primary objective:To demonstrate that CT-P10 is similar to Rituxan in terms of pharmacokinetics as determined by AUCtau and CmaxSS at Cycle 4 and maximum serum concentration at steady state The secondary objective:Efficacy: the primary endpoints…
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…
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 demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…
Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…
Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…
Primary objective:* To assess the safety and tolerability of combined treatment with atacicept and rituximab insubjects with active rheumatoid arthritis receiving re-treatment with rituximab.Secondary objectives:* To evaluate the effect of combined…
To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.
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 (…
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:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.
This study will evaluate the efficacy of brentuximab vedotin in combination with lenalidomide and rituximab among subjects with relapsed or refractory CD30-positive (CD30 expression >=1%) or CD30 <1% (CD30 expression <1%) DLBCL.
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…
The main objective is to study the efficacy of treatment with RTX in patients with relapsing PMR compared to placebo.
The main objective is to study the efficacy of treatment with RTX in patients with newly diagnosed PMR compared to placebo.