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This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-nave myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-nave MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Featured Speakers:

Arul Chinnaiyan, MD, PhD

(Rogel Cancer Center)

is the S.P Hicks Endowed Professor of Pathology and Professor of Urology at the University of Michigan Rogel Cancer Center. He also serves as the Director of the Michigan Center for Translational Pathology and is an Investigator of the Howard Hughes Medical Institute. His research interests focus on functional genomic and bioinformatic approaches to study cancer to understand tumor biology and discover genetic drivers.

Celeste Simon, PhD

(Abramson Cancer Center)

is the Scientific Director of the Abramson Family Cancer Research Institute and an Associate Director of the Cancer Center at the Perelman School of Medicine at the University of Pennsylvania. Her research focuses on how cells sense and respond to changes in the availability of molecular oxygen and nutrients. Her research team is currently studying how O2 sensing impacts tumor inflammation, metabolism, metastasis and overall disease progression.

Angie Smith, MD, MS

(UNC Lineberger Comprehensive Cancer Center)

is an Associate Professor and Vice-Chair of Academic Affairs at the University of North Carolina (UNC) Department of Urology in Chapel Hill. In addition, she is the Director of Urologic Oncology at the UNC Lineberger Comprehensive Cancer Center, where she treats GU malignancies, including bladder, prostate and kidney cancer. She has a background in health services research, and her research interests focus on patient-outcomes research, patient engagement and quality of care for bladder cancer.

Samra Turajlic, MBBS, PhD

(The Francis Crick Institute)

is the Chief Investigator of translational studies into melanoma and kidney cancer and an Independent Group Leader at The Francis Crick Institute. Her research focuses on the development of an evolutionary understanding of cancer for patient benefit. Dr. Turajlic is the Chief Clinical Investigator for the TRACERx Renal study, aiming to map how kidney cancer evolves.

Randy Vince, Jr. MD

(Rogel Cancer Center)

is a Society of Urologic Oncology (SUO) Fellow at the University of Michigan Rogel Cancer Center. While at the University of Michigan, Dr. Vince also earned a Master’s degree in computational medicine and bioinformatics. His research interests are focused on using precision medicine to combat the concept of racial biology and evaluate the intersectionality of environmental exposures and gene expression on tumor biology.

Genitourinary Cancers

This trial studies the side effects of enasidenib and to see how well it works in treating patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for cell growth.

Jamey Young, Ph.D.

  • Professor of Chemical and Biomolecular Engineering
  • Professor of Molecular Physiology and Biophysics
  • Director of Graduate Studies in Chemical Engineering
  • Director of Interdisciplinary Training in Engineering and Diabetes (ITED)

Phone

615-545-4812

Email

j.d.young@Vanderbilt.Edu
212B Olin Hall
2400 Highland Ave
Nashville, TN 37212

Jamey Young, Ph.D.

  • Professor of Chemical and Biomolecular Engineering
  • Professor of Molecular Physiology and Biophysics
  • Director of Graduate Studies in Chemical Engineering
  • Director of Interdisciplinary Training in Engineering and Diabetes (ITED)

615-545-4812

j.d.young@Vanderbilt.Edu

212B Olin Hall
2400 Highland Ave
Nashville, TN 37212

Research Program

Research Description

Have any questions? Contact Us 1-877-936-8422 for more information

Zhijun Yin, PhD

  • Assistant Professor

Phone

615-936-3690

Email

zhijun.yin.1@vumc.org
2525 West End Ave
Suite 1475
Nashville, TN 37203

Zhijun Yin, PhD

  • Assistant Professor

615-936-3690

zhijun.yin.1@vumc.org

2525 West End Ave
Suite 1475
Nashville, TN 37203

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information
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