82 results
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.
The primary objective is to investigate the rate of pathological responses following different neoadjuvant immunotherapy combinations in high-risk non-metastatic clear cell RCC in an adaptive trial design. And to study the safety and feasibility of…
In this study, we investigate whether induction with immunotherapy, followed by chemoradiation as consolidative therapy is an effective bladder-sparing therapy.
Primary Objectives:- To compare ORR (objective response rate) using RECIST 1.1 for NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma- To compare PFS (…
Primary Objective:The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Arm A nivolumab (240 mg q2w), Arm B nivolumab (240 mg q2w) plus relatlimab (80 mg q2w), and arm C nivolumab (240…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
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…
The primary objective is to demonstrate that the nivolumab steady-state level after 3 cycles with a reduced nivolumab dosage (240 mg every 4 weeks) is not lower than the nivolumab concentration 4 weeks after the first 480 mg or 6mg/kg dose.…
Primary Objective: To determine the safety and feasibility of pre-operative immunotherapy in CRC. Additional Primary Objective for the expanded the MSI cohort: To assess efficacy of neoadjuvant ipilimumab plus nivolumab in terms of disease-free…
The objective of this trial is to evaluate safety and tolerability of an experimental drug, EO2401, in combination with another immunological treatment, nivolumab, in patients with advanced or metastatic ACC and progressive MPP.
Primary Objective: To compare Overall Survival (OS) in patients with non-squamous NSCLC who have experienced disease progression on or after platinum-based chemotherapy and CIT, treated with sitravatinib and nivolumab versus docetaxel.Secondary…
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 primary objective of this study is to evaluate the patient preference for either ICI-B or ICI-P. Secondary objectives are: to assess patient satisfaction with ICI-B and ICI-P, to establish the safety of ICI-B and ICI-P to establish the…
The main objective of this study is to assess the safety of combining Nivolumab with IRE alone and of combining Nivolumab with IRE and CpG .The secondary objectives of this study are : 1) whether the combination of Nivolumab + IRE, or of CpG +…
The primary objective of this study is to evaluate the rate of ongoing response at 12 months after start of treatment in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early…