46 results
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 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 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: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.…
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: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 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.
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…
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
To determine the real-world pharmacokinetics of ICIs.
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:…
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 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:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
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…
Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. • To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. Secondary…
We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-L1 expressing tumours (membranous staining in > 1%) who are at high…
Primary objectives:• to assess the safety of combining nivolumab, ipilimumab and up to 3 fractions of medium dose hypofractionated radiotherapy (mRT) to multiple tumor sites (1 to 4, with at least 1 site receiving 24Gy)• to explore the efficacy of…
Primary objective:- To investigate if neo-adjuvant combination of talimogene laherparepvec and nivolumab will achieve a pathologic response rate of 45% complete responses (either *pathological complete response (pCR)* or *pathological near complete…