107 results
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic…
Primary objectives:* Part 1: To evaluate the safety and tolerability and determine the recommended dose(s) of INCB059872 for further study in advancedmalignancies.* Part 2: To further evaluate the safety and tolerability of INCB059872 for further…
Firstly, the objective of the study is to estimate the safety and tolerability of study treatments (firstly nivolumab alone, and then nivolumab in combination with ipilimumab) in pediatric participants with primary high-grade CNS tumors.Secondly,…
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…
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 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…
Primary ObjectivesPart 1 (Monotherapy Dose Escalation Phase):* To determine the recommended Phase 2 dose (RP2D) of SQZ AAC HPV monotherapy. * To characterize the safety and tolerability of SQZ AAC HPV administered as monotherapy. Part 2 (Combination…
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…
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…
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.
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.…
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 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 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…
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
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 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…