Tã¸llã¸se, Denmark
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Phase
2Span
288 weeksSponsor
Regeneron PharmaceuticalsMorristown, New Jersey
Recruiting
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Phase
N/ASpan
101 weeksSponsor
Biosense Webster, Inc.Morristown, New Jersey
Recruiting
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
Phase
1Span
261 weeksSponsor
Merck Sharp & Dohme LLCMorristown, New Jersey
Recruiting
Pancreatic Cancer Detection Consortium
Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease and it is unreliable for early detection. To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC. In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in accurately identifying PDAC at its earliest stages.
Phase
N/ASpan
141 weeksSponsor
City of Hope Medical CenterMorristown, New Jersey
Recruiting
Healthy Volunteers
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Phase
3Span
298 weeksSponsor
Jazz PharmaceuticalsMorristown, New Jersey
Recruiting
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
Phase
N/ASpan
119 weeksSponsor
Atlantic Health SystemMorristown, New Jersey
Recruiting
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)
Phase
3Span
529 weeksSponsor
Replimune Inc.Morristown, New Jersey
Recruiting
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab. The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: - Participants ≥30 kilograms (kg), Vedolizumab (High Dose) - Participants >15 to <30 kg, Vedolizumab (Medium Dose) - Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period: - Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W) - Participants ≥10 to <30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W) This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
Phase
3Span
127 weeksSponsor
TakedaMorristown, New Jersey
Recruiting
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Phase
3Span
161 weeksSponsor
CytokineticsMorristown, New Jersey
Recruiting
A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
Phase
N/ASpan
524 weeksSponsor
Ascendis Pharma Endocrinology Division A/SMorristown, New Jersey
Recruiting