60 results
Primary Objective:To investigate the pharmacodynamic activity of nivolumab, and nivolumab in combination with ipilimumab in the tumor environment and the periphery on biomarker measures such as circulating T cell subsets (activated and memory T…
Herewith, we present a research protocol that allows us to examine feasibility and safety of checkpoint blockade neoadjuvant to standard of care (SOC) in a patient population in need for improved clinical outcome and in tumors likely to respond to…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma
To evaluate the safety and efficacy of the combination of RFA and Ipilimumab in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma.
The primary objective of the study is the disease control rate (DCR) at 12 weeks of the combination treatment of Nivolumab and Ipilimumab in patients with progressive MPM.The secondary objectives are:- to determine the safety profile of the…
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…
Primary objective: To determine safety, feasibility, and the immune-activating capacity of short-term combined neo-adjuvant and adjuvant ipilimumab + nivolumab.Secondary objectives: To determine relapse free survival (RFS), any late adverse events,…
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 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…
1. To evaluate progression-free-survival (PFS) in patients with advanced MEL receiving either Pembrolizumab or IPI.2. To evaluate overall survival (OS) in patients with advanced MEL receiving either Pembrolizumab or IPI.
The primary objective is to evaluate if patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by consolidation treatment (nivolumab plus ipilimumab) have a better outcome in terms of progression-free survival (time…
In patients with neoadjuvant disease the purpose of the study is to define the safety and tolerability of the drug. In patients with metastatic disease the purpose is to determine if treatment with Nivolumab or Nivolumab and ipilimumab will lead to…
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
Primary Objectives:• To compare progression free survival (PFS) as determined by blinded independent central review (BICR) and overall survival (OS) of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin regimen as first…
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 objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with metastatic castration-resistant prostate cancer. Susceptible patients are selected for MMRd/high mutational burden/tandem…
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
Firstly, the objective of the study is to estimate the safety and tolerability of study treatments (firstly nivolumab alone, and then nivolumab in combination with ipilimumab) in pediatric participants with primary high-grade CNS tumors.Secondly,…