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CT Open to Enrollment

A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination with BNT116 (FixVac Lung) versus Cemiplimab Monotherapy in First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with Tumors Expressing PD-L1 ≥50%

The purpose of the study is to collect more information on the safety of BNT116 in combination with cemiplimab and to see how well combining the study drugs work in treating advanced non-small cell lung cancer (NSCLC).
   
The study is researching an investigational drug, called BNT116, in combination with cemiplimab. Investigational means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other drugs.
   

Multicenter randomized phase II trial of neoadjuvant radioimmunotherapy versus chemoimmunotherapy in patients with clinical stages IB-III (N2) non-small cell lung cancer

In this clinical trial, we hope to learn the effectiveness of cemiplimab with chemotherapy or cemiplimab with stereotactic body radiation therapy (SBRT) as treatment for clinical stage IB-III (N2) non-small cell lung cancer prior to surgery and cemiplimab for one year following surgery. 

Cemiplimab is approved by the U.S. Food and Drug Administration (FDA) for advanced disease, however, it is considered investigational in this study because it is not approved for early-stage disease.

Whole-Body Hyperthermia for Mood and Anxiety Disorders

The purpose of this study is to learn how whole-body hyperthermia (achieved in a sauna) may work to decrease feelings of depression and anxiety. We know that this intervention works in adults with depression, but we do not know how it works. We also want to find out if postpartum women will find this intervention acceptable, and whether the way it works may be different in postpartum women from other people. 

Do More, Feel Better: Lay-delivered Behavioral Activation in Senior Centers

The purpose of this study is to compare 2 forms of interventions for senior center clients over 60 experiencing symptoms of depression. 

Some participants enrolled in the study will receive 9 weeks of a type of psychotherapy called “Behavioral Activation” as delivered by a Master’s level mental health clinician. “Behavioral Activation” is a psychotherapy aimed at re-engaging participants in activities they once found rewarding and enjoyed but have abandoned after they developed depression.

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal Onset Seizures

The main purpose of this study is to determine if XEN1101 can reduce the seizure frequency and if it is safe to use. XEN1101 has been tested in other studies in epilepsy patients and it was considered to be well-tolerated. It had side effects that are similar to other antiseizure drugs commonly used to help patients with epilepsy.

XEN1101 is considered investigational, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). 

A Two-tiered, Phase II, Rule-based, Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib (TEW-7197) for the Treatment of Anemic Patients with Philadelphia Chromosome-negative Myeloproliferative Neoplasms

Currently, the treatments of anemia in patients with myeloproliferative neoplasms (MPNs) include blood transfusions (receiving red blood cells intravenously to replace the lack of functioning red blood cells), erythropoietin stimulating agents given as injections which will help stimulate red blood cell production in the bone marrow, and sometimes steroids. These interventions are supportive but are often insufficient and temporary as they are not capable of blocking the effects of the cancer cells causing anemia. 
   

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors

This study will investigate whether a new experimental treatment, ORM-5029, will be a safe and possibly effective treatment option for patients with solid tumors that have higher levels of a protein called HER2. The study is designed to find a safe and effective dose of ORM-5029.

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic TNBC

The purpose of this study is to determine whether an investigational drug called datopotamab deruxtecan (also known as Dato-DXd) is as good or better at treating locally recurrent inoperable or metastatic triple-negative breast cancer, as compared to a single standard chemotherapy. 

Dato-DXd is an investigational drug, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). The chemotherapy options used in this study are FDA-approved.