70 results
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…
The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…
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: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebobased on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- mTTS structural damage week 24-…
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: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…
To determine the real-world pharmacokinetics of ICIs.
OpACIN-neo:Primary objectives: - To compare safety (immune related adverse events during the first 12 weeks) of three different neo-adjuvant combination schemes of ipilimumab + nivolumab - To compare radiological and pathologic response rates at…
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…
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…
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:…
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…
Main Objective:To demonstrate the efficacy of secukinumab compared to placebo withrespect to HiSCR after 16 weeks of treatment.Secondary objective:To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with…
The purpose of this clinical research extension study is to evaluate whether prolonged treatment with secukinumab for up to another 4 years (Week 52 to Week 260) will bring benefits and be safe to patients with moderate to severe HS. The main…
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 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…
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…
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 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…
To evaluate the safety and efficacy of the combination of RFA and Ipilimumab in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma.