105 results
Evaluation of the effect of nivolumab and daratumumab with or without low dose cyclophosphamide in patients with relapsed/refractory multiple myeloma
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…
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…
The study will look at patients with chemotherapy-naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). The research aims to compare a new drug called nivolumab OR nivolumab with ipilimumab (another cancer drug) OR nivolumab combined with…
1. The primary objective of this phase I/II clinical trial is to evaluate the safety and toxicity of ACT plus nivolumab according to CTCAE 4.0 criteria. Toxicity grade 3 or less and SAE related to treatment but that does not result in treatment…
Primary ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…
Primary ObjectiveSafety Lead-in* Evaluate the safety of a high-dose regimen of encorafenib + binimetinib combination therapy in patients with BRAFV600-mutant melanoma who have asymptomatic brain metastasisPhase 2If the high-dose regimen is…
The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…
Main objective:Dose Escalation Part:• To assess the safety and tolerability of DF1001, and to determine the Maximum Tolerated Dose (MTD) of DF1001 in patients with Advanced (unresectable, recurrent, or metastatic) solid tumors for whom no effective…
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…
This translational study focusses on the altered / improved immune response triggered by the addition of radiation to immune checkpoint blockade therapy. The study is investigative in nature.Main study parameters/endpoints:a) Alteration / increase…
A Phase 1b trial in Stage II-III urothelial cancer to explore pre-operative immunotherapy - TURANDOT
We will assess feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
The aim of the study is to investigate the effectiveness and safety of the new drug nivolumab for the treatment of esophageal cancer. In addition, it is being investigated whether a blood test can be used to predict the effectiveness and possible…
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…
Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…
Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized participants. - To compare EFS of neoadjuvant nivolumab/BMS-986205 +GC followed by continued nivolumab/BMS-986205 after…
Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended phase dose (RPTD) of the combination of ipilimumab/nivolumab and PHP in patients with unresectable,…
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 determine the real-world pharmacokinetics of ICIs.