109 results
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…
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…
1) To assess uptake of [18F]BMS-986192 in tumor lesions before and after treatment with nivolumab, in relation to [18F]-FDG uptake as potential whole body biomarker for response. 2) To evaluate safety and tolerability of neoadjuvant nivolumab 3) To…
To determine the real-world pharmacokinetics of ICIs.
In this study, we investigate whether induction with immunotherapy, followed by chemoradiation as consolidative therapy is an effective bladder-sparing therapy.
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…
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 objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with metastatic castration-resistant prostate cancer. Susceptible patients are selected for MMRd/high mutational burden/tandem…
Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…
Primary objective:-To increase 12 months DFS of DH/TH-HGBL patients in CMR after DA-EPOCH-R from 70% to 85% with nivolumab consolidation treatmentSecondary objectives:-To evaluate CMR rate after DA-EPOCH-R-To evaluate 18 months event free survival (…
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 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…
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,…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
Primary:* Phase 1b:o Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of binimetinib administered in combination with nivolumabo Determine the MTD and RP2D of binimetinib administered in combination with nivolumab plus…
Primary objective:To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients; i.e. the primary endpoint is Disease-free survival (DFS) in arm A at 12 months, defined as the number of patients alive and free of…
The primary objective is:• To evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per…
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…