66 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 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,…
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 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 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…
Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…
In this randomized controlled phase III study we will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared…
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…
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…
Primary objective • To compare the event-free survival (EFS) of neoadjuvant ipilimumab + nivolumab (followed by adjuvant nivolumab or dabrafenib + trametinib in patients not achieving a pathologic response) versus standard adjuvant nivolumab.
Primary objectives: - To assess safety and feasibility of neoadjuvant nivolumab +/- domatinostat +/- ipilimumab- To identify pathologic response rates of nivolumab +/- domatinostat +/- ipilimumabSecondary objectives: - To describe all grade…
Primary objectiveTo determine the pathological complete response rate per cohort
• To assess the relation between 18F-PD-L1 PET/CT outcome measures and progression-free survival of >=9 months according to RECIST 1.1.• To assess the relation between 18F-PD-L1 PET/CT outcome measures and patient outcome in terms of PFS and…
The co-primary endpoints of this study are PFS in intermediate and poor-risk subjects, as assessed by an Independent Radiology Review Committee (IRRC) and OS in intermediate and poor-risk subjects. The final analysis of PFS will occur after 583…
Main objective: To assess PFS rate at 6 months in patients treated with nivolumab or the combination of nivolumab and ipilimumab, with relapsed/advanced thymic carcinoma and type B3 thymoma not amenable to curative-intent radical treatment and…
Primary Objectives• To compare the of OS rate at 12 months of Nivolumab combined with Ipilimumab to standard of care in patients with previously untreated and advanced non-clear cell RCC, Secondary Objectives• To compare the OS rate at 6 and 18…
*In the phase Ib study: to assess the feasibility and safety of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.*In the phase II study: to assess the impact of the addition of the addition of nivolumab…