108 results
Primary Objective:To investigate the pharmacodynamic activity of nivolumab, and nivolumab in combination with ipilimumab in the tumor environment and the periphery on biomarker measures such as circulating T cell subsets (activated and memory T…
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,…
Main objective of this phase 2 trial is to evaluate efficacy of nivolumab in symptomatic brain metastases of metastatic melanoma patients. In addition, the efficacy will be compared between patients with previously locally treated (e.g. surgery,…
In Small Cell Lung Cancer patients the purpose of this study is to compare the overall survival of patients on Nivolumab with patients on Topotecan after they have been treated with platinum -based first line chemotherapy.
Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
The main goal of neoadjuvant therapy should be a pathological complete response (pCR), because pCR more accurately predicts improved patient outcome and prolonged survival. In the present study, pathological response will be evaluated by The Miller…
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…
Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…
Primary objective: To assess the feasibility of the addition of nivolumab consolidation to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B NSCLC, as defined by the rate of grade *3 pneumonitis (CTCAE V4.0) 6 months…
To evaluate the safety and toxicity of ACT and low-dose IFN-alpha plus nivolumab according to CTCAE 4.0 criteria. Toxicity grade 3 or less and SAE related to treatment but that do not result in treatment termination are considered acceptable for…
To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.
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 ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…
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…
The primary objective of this trial are:- To determine the incidence of high-grade (CTCAE v4.0 Grade 3 orhigher), treatment related, select adverse events in patients withhistologically confirmed stage III (unresectable) or stage IV melanomaand…
To establish the efficacy and safety of nivolumab administered as a flat dose in combination with weight-based ipilimumab dosing.
The main research question is whether or not the administration of nivolumab increases "overall response rate" (ORR) in patients with classical Hodgkin Lymphoma who have progressed or relapsed following autologous stem cell transplant (…