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89Zirconium-labeled nivolumab and 18F-labeled anti-PD-L1 as predictive imaging biomarkers of response and toxicity in nivolumab treated patients with non-small-cell lung cancer * a feasibility study

To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.

A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)

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…

A phase II trial evaluating the safety and efficacy of the addition of concurrent anti-PD-1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma

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…

A multi-center, open-label study to assess the safety and efficacy of combination ceritinib (LDK378) and nivolumab in adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (CLDK378A2120C)

Primary: 1. To determine the MTD and/or RDE of the combination ceritinib and nivolumab. 2. To assess the preliminary antitumor activity of the combination.Secondary: 1: To assess the safety profile of the ceritinib and nivolumab combination. 2: To…

Adoptive TIL therapy plus anti-PD1 in metastatic melanoma

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…

An exploratory study of the biologic effects of nivolumab and nivolumab in combination with ipilimumab treatment in subjects with advanced melanoma (unresectable or metastatic).

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…

MR Imaging of cerebral blood flow and autoregulation in patients with steno-occlusive vertebro-basilar artery disease.

The primary objective will be to assess whether cerebrovascular reactivity is impaired in patients with steno-occlusive disease of the vertebrobasilar artery .

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher
Disease Type 1

The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…

The effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus in patients with an affective disorder: a pilot study

To study the effect of acetazolamide on lithium-induced NDI.

A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.

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…

Whole brain measurements of regional vasomotor reactivity in patients with carotid obstruction

The objective of this study is to to develop a selective and non-selective whole brain ASL perfusion stress test and at 3.0 Tesla based on ASL flow territory measurements.

Acetazolamide and the ventilatory response to acidosis and hypoxia in healthy volunteers

1. What is the effect of a clinical oral dose of acetazolamide on the isocapnic hypoxic response (IHR), i.e. an exposure to hypoxia (end-tidal PO2 ~ 5.8 kPa) during 30 min? Does the agent increase the IHR as would be expected from the state of…

Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in resectable stage III melanoma patients (OpACIN)

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,…

ImmunoModulation by the Combination of Ipilimumab and nivolumab neoadjuvant to Surgery In advanced Or recurrent Head and Neck Carcinoma, (IMCISION), a phase-Ib/II trial. Subtitle: Hypoxia as a determinant for the effect of nivolumab with or without ipilimumab on intra-tumoral T cell capacity

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…

An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of nivolumab in metastatic melanoma patients with symptomatic brain metastases.

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,…

An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in subjects with Relapsed Small-cell Lung Cancer after Platinum-based First Line Chemotherapy

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.

Ipilimumab plus Nivolumab and ChemoRadiotherapy followed by Surgery in patients with resectable and borderline resectable T3-4N0-1 NSCLC

Primary objective:• To assess the safety and feasibility of adding ipilimumab-nivolumab to a CRT induction protocol• To assess the efficacy of adding ipilimumab-nivolumab to CRT on the likelihood of a pCR and MPRSecondary objectives: • Local and…

Neo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.

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…

Phase 2 Study testing the COmbination of Vemurafenib With Cobimetinib in BRAF V600 mutated Melanoma Patients to Normalize LDH and Optimize immunotherapY with Nivolumab and Ipilimumab (COWBOY)

Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…

A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer

To establish the efficacy and safety of nivolumab administered as a flat dose in combination with weight-based ipilimumab dosing.