Clinical trials

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STaRT

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

PRECISE

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.

In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.

Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

DB1311-201: A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants.

Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)

To determine the efficacy of acoramidis to prevent ATTR (ATTRCM or ATTR-PN, whichever occurs first) in asymptomatic carriers with a pathogenic TTR variant who are at risk of developing ATTR but have no clinical evidence of disease at study entry.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of IFx-Hu2.0 As an Adjunctive Therapy to Pembrolizumab in Checkpoint-Inhibitor Naïve Participants with Advanced or Metastatic Merkel Cell Carcinoma

This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.

Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction (ELEVATEHFpEF)

The purpose of the study is to evaluate the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of HFpEF. Personalized pacing is defined as programming a pacemaker's lower rate to a value based on the patient's LVEF and height.The results from this study may be used to support an indication for a personalized cardiac pacing rate in patients with HFpEF.

Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center

The current research surrounding the short- and long-term effects of burn pit exposure and its association with various cancers is limited. The primary objectives of this pilot study are:  1) determine the feasibility and participant satisfaction associated with a more intensive cancer screening regimen in this population; 2) describe the clinical and psychosocial impact such screening has on this potential population; and 3) describe the premalignant and malignant findings identified and follow-up healthcare utilization associated with high-intensity cancer screening during the approximately 3-year study period (three annual screening assessments and an additional year of follow-up to determine participants' cancer status). As an exploratory objective, we will also describe the performance of novel investigative tools (nasal brush, multi-cancer detection blood test, and radiomic analysis) in detecting the development of malignancies during the study period.

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive

The goal of this research study is to test a new study treatment for a specific type of stomach cancer. It is focused on people whose tumors are CLDN18.2 positive, PD-L1 positive, and HER2 negative. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
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