23 results
Primary objective of this trial is to generate open-label, long-term (up to 12 months) safety and tolerability data for ZS in subjects with hyperkalaemia (S-K * 5.1 mmol/L)Secondary objectives:* To evaluate the portion of ZS-treated subjects in whom…
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…
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…
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…
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…
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
Primary objectives - To evalulate the association between baseline tissue TMB/blood TMB and clinical efficacy (Objective Response Rate) for participants in Part 2- To evaluate the correlation between baseline tissue TMB and blood TMB for…
PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…
Primary Objectives: - To characterize the safety, tolerability, and DLTs and to determine the MTD/RP2D of BMS-986218 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors- To evaluate the efficacy…
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…
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:• To compare Blinded Independent Committee for Radiology (BICR)-assessed objective response rate (ORR) in participants of tissue Tumor Mutational Burden-High (tTMB-H) treated with nivolumab combined with ipilimumab • To compare…
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…
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…
To establish the efficacy and safety of nivolumab administered as a flat dose in combination with weight-based ipilimumab dosing.
Primary:* Phase 1b:o Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of binimetinib administered in combination with nivolumabo Determine the MTD and RP2D of binimetinib administered in combination with nivolumab plus…
The primary objective is to compare the OS in patients treated with IMCgp100 monotherapy versus Investigator*s Choice in HLA-A*0201 positive patients with advanced UM with no prior treatment in the metastatic setting. The secondary objectives of the…
Part A:* To obtain evidence of antitumor effect of CX-072 in combination with ipilimumab in subjects withsolid tumors based on the objective response rate (ORR) as defined by the Response EvaluationCriteria in Solid Tumours (RECIST) v1.1Part B:* To…