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CT Open to Enrollment

Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of participants with unresectable Hepatocellular Carcinoma (HCC, a.k.a. liver cancer).

Eye90 is comprised of tiny glass beads containing yttrium-90 (Y90), a radioactive material. The beads are delivered in and around the tumor(s) through a tiny catheter placed through the artery of the groin or wrist and into one or more branches of the artery of the liver under x-ray camera guidance.

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab

This clinical trial is for adult participants who have triple-negative breast cancer (TNBC).
   
The purpose of this study is to evaluate the safety and effectiveness of the study drug datopotamab deruxtecan (also called Dato-DXd) given in combination with another investigational drug called durvalumab.
   
Dato-DXd and Durvalumab are experimental, which means that they are being tested and are not approved by the United States Food and Drug Administration (FDA).
   

A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

This clinical trial is for men and women with myelofibrosis.
   
The purpose of this study is to test the safety and tolerability of INCB057643 in combination with ruxolitinib on people with myelofibrosis. 
   

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).

Camizestrant is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with large B-cell lymphoma and follicular lymphoma approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Axicabtagene ciloleucel is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

Local Methotrexate Injections for the Treatment of Nail Psoriasis

This study is evaluating the efficacy of methotrexate injections for treatment of nail psoriasis.

Participants in this study will receive three injections into three different nails: one nail will receive methotrexate, one nail will receive triamcinolone acetonide, and one nail will receive a placebo (no medication) injection.

Triamcinolone acetate and methotrexate are both approved by the U.S. Food and Drug Administration, however, nail injections for nail psoriasis are not an approved use of methotrexate by the FDA.

Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial

The LimFlow™ System, PMA P220025, received U.S. Food and Drug Administration (FDA) approval on September 11, 2023. The purpose of this post-approval study is to provide additional information on a device designed to create a connection between the artery and vein in the Below The Knee (BTK) vascular system, using a minimally invasive approach. This procedure is only indicated for patients with “chronic limb-threatening ischemia” who are not likely to be helped with standard operations or procedures and are at risk of major amputation.

A Study to Evaluate the Safety and Effectiveness of the Standard of Care Diversion, Diverting Ileostomy, Following Low Anterior Resection

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard-of-care cancer treatment.
   

An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC Cell Therapy for the Treatment of Chronic Anal Fissure

 This study is evaluating the initial safety and efficacy of local injections of E-CEL UVEC cells, which are genetically engineered (pro-survival gene, E4ORF1+), human umbilical vein endothelial cells, as an experimental treatment of patients with chronic anal fissure (CAF) who have failed medical therapy (i.e., topical vasodilators ± botulinum injection). 

Experimental means that E-CEL UVEC is not approved by the U.S Food and Drug Adminstration.