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A PHASE 1/2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE RECOMMENDED DOSE AND REGIMEN OF DURVALUMAB (MEDI4736) IN COMBINATION WITH LENALIDOMIDE (LEN) WITH AND WITHOUT DEXAMETHASONE (DEX) IN SUBJECTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM)

Main objective:Determine the recommended dose of durvalumab in combination withLEN +/- dex in subjects with NDMM.Secondary objectives:- Evaluate the safety and preliminary efficacy of durvalumab incombination with LEN +/- dex in subjects with NDMM-…

A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination with Nivolumab
and/or Ipilimumab in Subjects with Advanced Solid Tumors

The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab in…

A Phase 1/2, Single-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered
ALN-GO1 in Healthy Adult Subjects, and Patients with Patients with Primary Hyperoxaluria Type 1

Primary* Evaluate the safety and tolerability of single- and multiple-ascending doses of ALN-GO1, respectively, in healthy adult subjects and in patients with PH1Secondary* Characterize the pharmacokinetics (PK) of ALN-GO1* Evaluate the…

Can goal directed nutritional support reduce sarcopenia in surgical oesophagus patients?

This study investigates the impact of a goal directed nutritional support protocol on sarcopenia in oncological patients undergoing an esophagectomy and secondary the incidence of anastomotic leakage and pneumonia, surgical infection and lenght of…

A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of NeoGAA (GZ402666) and Alglucosidase Alfa in Treatment naïve Patients with Late-onset Pompe Disease

The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…

Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy

The main purpose of this pilot study is to assess the feasibility and potential efficacy of implant retained mandibular advancement device (MAD) therapy on a small scale in edentulous patients with mild to moderate OSA in terms of sleep apnea…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab plus Docetaxel versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or after Platinum-Based Therapy.

The primary objective of this study is to compare the progression-free survival (PFS) of ramucirumab in combination with docetaxel with the PFS of placebo in combination with docetaxel, in patients with locally advanced or unresectable or metastatic…

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

The objective is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC).

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration.

The objective of Study M14-115 is to evaluate efficacy and safety of higher induction and maintenance dosing regimens in subjects with moderately to severely active Crohn's disease.

Radioactive iodine treatment versus hemithyroidectomy in patients with symptomatic benign euthyroid goitre

To compare the effect of radioactive Iodine or hemithyroidectomy on the symptoms and quality of life (QoL) of patients with a benign euthyroid goiter.

Families in the Frontline 2.0: An evaluation of the After Deployment, Adaptive Parenting Tools (ADAPT)
parenting intervention for veteran families

Primary objective is to investigate the effectiveness of ADAPT vs TAU on family functioning of veteran families as reported by the veteran. Secondary objective is to investigate the effectiveness of ADAPT versus TAU on family functioning as reported…

Families in the Frontline 1.0: An Evaluation Study of Multi-Family Therapy (MFT) for Veteran Families

1) To investigate the effectiveness of Multi-family therapy (MFT) versus individual oriented treatment as usual (TAU) on end-of-treatment family functioning of veteran families, as reported by the veteran. TAU consists of supportive counselling or…

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy
of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Primary Objective:The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and MTD/MAD/alternate dose of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors.…

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer*s disease; part II: open-label extension for participating patients

The primary efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB

Pharmacokinetics of posaconazole given as a single intravenous dose to obese subjects: Dosing Obese with Noxafil® Under a Trial (DONUT).

Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of DS-1040b when Added to Standard of Care Anticoagulation Therapy in Subjects with Acute
Submassive Pulmonary Embolism.

The primary objective of this study is to evaluate the safety and tolerability using bleeding as the primary endpoint. Secondarily, this study will serve as a proof-of concept by evaluating the effect that DS-1040b administration has on total…

Immunogenicity and safety study of a third measles mumps rubella (MMR-3) vaccine dose in healthy young adults in The Netherlands

Primary objective: * The main objective is to assess the effect of third dose of MMR (MMR-3) in young adults 18-25 years of age on the development and duration of mumps-specific serum virus neutralization (VN) and IgG antibody concentrations (…