Office of Research
Clinical Trials

HNSCC Longitudinal Multiomic Study

This is a non‑interventional, forward‑looking study that will collect blood and tumor tissue from adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma who are starting first‑line anti‑PD‑1 or anti‑PD‑L1 therapy as part of usual care. Samples will be tested using next‑generation sequencing (NGS), circulating tumor DNA (ctDNA) assays, RNA and immune profiling, and other multiomic techniques. Collections occur at baseline and at multiple time points during treatment and follow up. The goal is to find biomarkers that help predict who will benefit from treatment, understand how cancers become resistant, and link biomarker changes to real‑world outcomes like survival and time to next treatment. Participants are followed for up to five years; no experimental treatments are provided as part of the study.

This study may be appropriate for those with: Metastatic Cancer

Study of JZP898 for Advanced/Metastatic Solid Tumors

This clinical research study is focused on understanding how a new drug called JZP898 works in adults who have advanced or metastatic solid tumors. The study is taking place in two parts. In the first part, researchers are exploring how the drug works on its own and when combined with another drug, pembrolizumab. They aim to find a safe dosage and look for any potential side effects. In the second part, they will further explore the effects of the combination of these two drugs on different types of tumors. The researchers want to know if these treatments can shrink the tumors and are safe for people to use over a long time. They will keep track of how the participants react to the treatment and measure things like how long the drug stays in their system and if it has any unwanted effects. People who want to participate must meet certain conditions, like having a specific kind of tumor and being able to care for themselves daily without too much help. This study is supported by Jazz Pharmaceuticals.

This study may be appropriate for those with: Metastatic Cancer

Safety and Effectiveness of PYX-201 in Solid Tumors

This study is testing a new drug called PYX-201 in adults with advanced solid tumors that have not responded to usual treatments or for whom there are no suitable treatment options. The goal is to find out what dose of the drug is safe and can be tolerated well. Researchers will monitor participants to see how their bodies react to the drug, including any side effects and how the drug moves through their system. Participants must be adults with certain cancers, such as breast, lung, or ovarian cancer, who meet health criteria like having normal kidney and liver function. The study aims to explore both the safety and preliminary effectiveness of PYX-201 over approximately 3 years. It is open-label, meaning all participants receive the drug, and no placebo is involved. Measurements will focus on potential toxicities and adverse events as well as biological markers from blood samples. Participants must not have severe infections or other active cancers. The research hopes to pave the way for further clinical development if results are promising.

This study may be appropriate for those with: Recurrent Cancer

Phase I/​ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Head and Neck Cancer

This study tests a short course of radiation (either standard X-ray photon radiation or proton radiation) given before surgery together with the immunotherapy drug pembrolizumab for people with recurrent head and neck squamous cell carcinoma. Phase I will enroll small groups to find a safe radiation dose and make sure combining the treatments before surgery is tolerable. Phase II will randomly assign patients to receive either proton or photon radiation plus pembrolizumab before salvage surgery and compare the rate of major pathologic response (very low remaining tumor on the removed tissue) to historical results. About 40 patients will be screened and randomized. Key goals are safety, whether the combination increases major pathologic response, and longer-term outcomes like disease-free and overall survival. The study includes tissue and immune testing to learn how the treatments affect the tumor and microenvironment.

This study may be appropriate for those with: Recurrent Cancer

Study of Ficerafusp Alfa and Pembrolizumab for Head and Neck Cancer

This study focuses on patients with certain types of head and neck cancers that have come back or spread. Researchers are testing a drug called ficerafusp alfa along with pembrolizumab, comparing it to a placebo with pembrolizumab. The aim is to see if the combination is safe and works better than the placebo. The study will happen in two phases. The first phase selects the best dose of ficerafusp alfa. The second phase will see how effective the treatment is when compared to a placebo, with patients randomly assigned to receive either the active treatment or a placebo. Key goals include measuring the response rate of tumors and overall survival among participants, while watching for side effects.

This study may be appropriate for those with: Newly Diagnosed Cancer

Home Telerehab After Stroke

This study tests whether adding a home telerehabilitation program to usual post-stroke care improves arm movement and overall ability after a stroke. People who had a stroke about 4 months earlier and have moderate weakness in one arm are randomly placed into one of two groups: (1) telerehabilitation plus usual care, or (2) usual care alone. The telerehab program includes 36 remote training sessions made of exercises, interactive games, and stroke education that total 70 minutes per day, six days a week, for about 6 weeks. Participants stay in the study for about 8 months and come to four in-person visits for arm tests and one brain MRI. The main goal is to see if arm function improves more at 2 months in the telerehab group, and a secondary goal is to see if overall disability is reduced. People in the usual care group are offered the telerehab program after the study ends.

Cilostazol Prevent Recurrent Stroke

This is a phase 3, randomized trial testing whether adding the medicine cilostazol to a person's current antiplatelet drug (either aspirin or clopidogrel) helps prevent another stroke, heart attack, or death from blood vessel disease. People who had a stroke or mini‑stroke (TIA) in the past 180 days and who are taking one antiplatelet drug may join. Participants will be followed for up to 4 years to see how long it takes for major events (stroke, heart attack, or vascular death) to occur. The study will also track time to ischemic stroke and the time to any major bleeding events. People with a recent spontaneous brain bleed, significant heart failure, or a life expectancy under 6 months are not eligible. The trial is not yet recruiting.

New Surgical Tool for Brain and Skull Base Surgery

This research is studying a surgical tool called DuraStat that is used to help close the protective lining around the brain during certain skull base surgeries done through the nose. Sometimes this lining is opened during surgery and needs to be carefully repaired to prevent fluid leaks or infection. The study will follow adults who are already having this type of surgery and need a repair during the procedure. Doctors will look at how well the repair works and how patients heal over time. Follow-up visits are part of normal surgical care, and participation does not require extra procedures beyond standard treatment.

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

This study may be appropriate for those with: Newly Diagnosed Cancer

Self Collection HPV Screening Study

This study tests whether people who collect their own vaginal sample for HPV testing get results that are as accurate as samples collected by a clinician during a pelvic exam. Adults 25 and older who were referred for colposcopy because of an abnormal cervical screening test will first collect a vaginal sample themselves, then have a clinician collect a cervical sample and undergo standard colposcopy with biopsy or other procedures if needed. Lab results are compared to see how well self-collection detects high-risk HPV and signs of cervical precancer or cancer. The study also asks participants about ease of use, comfort, and preferences for self-collection. Results will help guide use of self-collection for cervical cancer screening and possible regulatory decisions.

Dystonia Coalition Projects-3

The overall mission of the Dystonia Coalition is to develop a better understanding of the dystonias so that we may improve treatment. Presently, there are four related projects; the first three projects are grouped together because they are related. The last project will be open only to selected participants as an option. 1. Natural History (NH) Project: The aim of this observational project is to better characterize the heterogeneity of clinical manifestations among subjects with dystonia, how these manifestations evolve over time, and how they relate to other family members. A fuller understanding of clinical features and especially their evolution over time is an essential prerequisite for testing any potential disease-modifying therapies that could alter the course of the disorder. 2. Objective Measures (OM) Project: The aim of this project is to exploit technological advances for development of objective tools to measure the severity of dystonia. Current diagnostic and severity measures depend almost entirely on subjective clinician-rated or patient-rated scales. New technology could ultimately replace these subjective scales as outcome measures. They could also be used for telemedicine. This study is not interventional, but instead relies on video recordings or motion sensors that can non-invasively detect movements. 3. Biobank (BB) Project: The aim of this project is to develop a resource that expands the existing dystonia DNA biorepository to include other biomaterials. To date, no large multicenter open-access biorepository exists for any type of dystonia. Such a biobank is essential for improving our understanding of the pathogenesis of the dystonias, so that rational therapies can be planned. It also is essential for exploration of biomarkers of disease activity that may provide useful outcome measures in clinical trials, or insights into pathogenesis. This study also is not interventional. 4. Patient-Centered Outcomes (PCO) Project: The aim of this project is to delineate both between-subject and within-subject variations over time in response to the standard of care treatment with Botulinum toxin (BoNT) injections. Typically, injections are required about every 3 months. Therapeutic benefits emerge within the first week and then wear off after 8-16 weeks, creating a cyclical response known as the "yo-yo" effect. The development of any novel "add-on" therapeutics or replacement therapeutic is hampered by incomplete knowledge of individual temporal responses. Currently, measurement tools rely on clinical rating scales which are subjective, cumbersome for repeated frequent use, and require extensive expertise to apply. This project will develop a patient-facing tool on a hand-held electronic device, such as a smartphone. This is not an interventional study; it aims to collect data regarding responses to routine clinical treatments.

Long-Term Study of People Living with Bipolar Disorder

This study is following adults who have bipolar disorder over several years to better understand how their moods, health, and daily life change over time. Participants take part in interviews, surveys, memory and thinking tests, and brain scans, and may wear a Fitbit or use a phone app to track sleep and activity. The goal is to learn why bipolar disorder affects people differently so future care can be more personalized and effective.

TQR-84 (Placebo Study)

Patients will be told they are receiving either a novel medication (TQR-84) or placebo. However, all participants will receive IR-CD/LD. We will evaluate the differences on motor improvement after levodopa introduction, as measured by the motor subscale of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III),13 between a positive framework (to enhance expectations) compared to a neutral framework (to dampen expectations).

ALTO ED Integrative Health Referrals

This study tests whether routinely offering ED patients a referral to integrative health services increases use of nonpharmacologic options and reduces opioid prescribing and opioid consumption. Qualifying ED patients (age ≥18) presenting with low back pain, headache, abdominal pain, certain mental health conditions, or suspected substance use disorder will be offered a referral to the Osher Center for Integrative Health. Services available include acupuncture, mindfulness therapy, music therapy, massage, movement therapies (tai chi, yoga), lifestyle coaching, and nutrition education. The intervention is operationalized by adding the Osher Center referral to the ED preference list in the electronic health record to make it easy for ED clinicians to offer and place referrals. Participants will complete a baseline visit in the ED and a 30-day follow-up phone call to capture referral uptake, opioid prescriptions written, opioid use, pain and symptom measures, and patient experience. Patients who are pregnant, prisoners, unable to consent, actively suicidal/on psychiatric hold, febrile, trauma activations, or with altered mental status are excluded. Total participation time is 30 days (baseline plus one follow-up). The primary goals are to increase integrative health referrals and uptake and to decrease opioid prescribing and patient-reported opioid consumption after ED discharge.

Studying a Switch in Treatment for Relapsing Multiple Sclerosis

This study is testing whether a daily oral medicine called remibrutinib works as well as the current treatment, ocrelizumab, for people with relapsing multiple sclerosis. People who have been on ocrelizumab for at least 18 months and are between 40 and 70 years old may join. The study will look at how MS changes over time using MRI scans, physical tests, and symptom reports. Participants may receive remibrutinib or continue ocrelizumab for up to two years, and those who finish this part may continue on remibrutinib for another two years. The study aims to learn whether switching to remibrutinib is safe, effective, and easier for patients.

Translational Pulmonary Science Center

Researchers are trying to learn more about diseases related to pulmonary, critical care, and sleep medicine. Much of this research is done using human tissue and health information. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some studies may lead to new products, such as drugs or tests for diseases. A repository makes it easier for researchers to perform studies, since samples and information from many different people will be available in one place. Researchers can use samples and information only after their project is approved by a human protection review board, and samples are only dispensed after review by the Translational Pulmonary Science Center (TPSC) research committee.

Understanding Inflammation During Pregnancy and Preterm Birth

This study aims to learn how inflammation during pregnancy affects both mothers and babies, especially when a baby is born early. Researchers will collect blood and tissue samples after birth. These samples help scientists understand how conditions like infection or inflammation inside the uterus may lead to early labor or health problems for newborns. Participation does not change medical care and involves no follow-up. The information collected may help improve future care for pregnant people and babies.

Use of a new medication for prevention of fetal/neonatal thrombocytopenia (low platelets)

Fetal neonatal alloimmune thrombocytopenia (fNAIT) is a rare disease in pregnancy in which women develop antibodies against proteins on platelets (the cells in our blood that are help with clotting). These antibodies can cross the placenta in pregnancy and, if the fetus has that protein on his/her platelets, they can cause destruction of these cells. This results in thrombocytopenia (low platelets) and can lead to severe bleeding events. Standard prevention of disease in pregnancy includes immune suppression with something called IVIG and prednisone. We are comparing this treatment to a novel treatment using a medication called nipocalimab, a treatment that aims to block transfer of the antibodies across the placenta. Patients will be randomly assigned to receive either nipocalimab or the IVIG+Prednisone, and we will monitor the safety and response in the fetus and baby.

Efficacy and Safety of Iptacopan for IC-MPGN

This study is investigating iptacopan's effectiveness and safety for treating idiopathic immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). People aged 12-60 with IC-MPGN who are already on stable treatment may participate. The study will compare iptacopan with a placebo in terms of reducing protein levels in the urine and improving kidney function (measured by eGFR). It also assesses whether patients feel less fatigued. After completing the study, participants can choose to continue iptacopan in another study. The study involves safety monitoring, includes vaccinations for certain infections, and is open only to those meeting specific health criteria without certain exclusions.