Office of Research
Clinical Trials

Investigating NBTXR3 and Radiation for Head and Neck Cancer

This study is testing a treatment called NBTXR3 to see how well it works when combined with radiation therapy, compared to just using radiation therapy with or without a drug called cetuximab. The research is focused on elderly patients who have advanced head and neck squamous cell cancer but cannot undergo platinum-based chemotherapy. Participants will be randomly assigned to two groups; one will receive NBTXR3 with radiation therapy, and the other will receive radiation therapy alone or with cetuximab as chosen by their doctor. The goal is to track how long patients live without their cancer getting worse and overall survival, among other measures. The treatment happens over 7 weeks, with a series of follow-up visits planned afterward.

This study may be appropriate for those with: Metastatic Cancer

Amivantamab Versus Cetuximab in cSCC

This study is testing a new treatment approach for people with cutaneous squamous cell skin cancer that has come back or spread and who have weakened immune systems. Participants are placed into one of two groups. One group gets amivantamab given under the skin together with hyaluronidase to help the drug stay in the body longer. The other group gets cetuximab given into a vein. Treatment is given in 28-day cycles for up to about 24 cycles unless the cancer gets worse or side effects are too severe. Doctors will check safety, how well the cancer responds, and how long people live without cancer growth. Blood tests and scans will be done throughout treatment, and some patients will be followed afterward for years. The study also collects samples for future research.

This study may be appropriate for those with: Metastatic Cancer

Studying Whether Tranexamic Acid Improves Visualization and Recovery in Rotator Cuff Surgery

This study is testing whether adding a small amount of tranexamic acid (TXA), a medication that helps reduce bleeding, to the irrigation fluid used during shoulder arthroscopy can improve the clarity of the surgical view and affect early recovery. When surgeons operate with a camera inside the shoulder, bleeding can cloud the view, making surgery more difficult. TXA might help reduce this bleeding. Adults who are scheduled for arthroscopic rotator cuff repair may be invited to join. After giving consent, patients are randomly assigned to one of two groups: Standard saline irrigation, or Saline irrigation with a low dose of TXA mixed in. Neither the patient nor the surgeon will know which one is used to keep the study fair. The surgery is performed using the usual minimally invasive technique. The video from the procedure is recorded so that surgeons can later rate how clear the view was at different points in the operation. After surgery, patients will have their shoulder movement checked, complete short surveys, measure pain at 8, 24, and 48 hours, and have their swelling measured. Doctors will also review the medical record for information such as operative time, bleeding, hemoglobin changes, and any complications. Patients continue routine clinic follow‑up at 6 weeks and then at 3, 6, 12, and 24 months, completing questionnaires about pain, function, and health. All visits are part of standard postoperative care; no extra visits are required. The purpose of this double‑blind study is to find out whether TXA can safely improve visualization during surgery and possibly help with pain control or reduce complications. The results may help guide future shoulder surgery practices.

BLU 263 ISM Treatment Study

This study tests BLU-263 (elenestinib) versus placebo in people with indolent systemic mastocytosis whose symptoms are not controlled by usual medicines. Participants continue symptom-directed therapy (like antihistamines, proton-pump inhibitors, cromolyn, or corticosteroids) while getting either BLU-263 or placebo. The trial has several parts: short-term randomized blinded parts to measure symptom change and safety at about 13 or 49 weeks, plus an open-label long-term part where participants can continue BLU-263 for up to 5 years to monitor ongoing safety and benefit. Some groups enroll people who previously took a KIT inhibitor and special pharmacokinetic groups check how the drug behaves in the body. Main measures include changes in a validated symptom score, safety events, blood tryptase and KIT D816V levels, bone marrow mast cells, quality of life, anaphylaxis rate, and bone health.

Targeted Therapies Crohns Disease

This is a Phase 2, randomized study testing several targeted medicines for adults with moderate to severe Crohn's disease. About 540 people will be enrolled worldwide and will be randomly assigned to one of the available study treatments. The medicines being tested include risankizumab, trosunilimab, and ABBV-8736, given by injection under the skin or by vein infusion depending on the drug. The main goal is to see how many participants reach endoscopic remission at Week 12. Participants will have regular clinic visits, blood tests, endoscopies, safety checks, questionnaires, and a daily diary to track symptoms and side effects.

Treprostinil for PH ILD Study

This is a Phase 3 randomized, double blind, placebo controlled study testing an inhaled medicine called treprostinil palmitil inhalation powder (TPIP) in adults who have pulmonary hypertension from fibrotic interstitial lung disease. Participants will take TPIP or a matching placebo once daily for 24 weeks. The main goal is to see if TPIP improves exercise ability measured by the six minute walk test at 24 weeks. The study also looks at clinical worsening events, major illness or death, a blood marker of heart strain (NT proBNP), symptom scores, and blood drug levels. People must have their lung scarring confirmed by CT and pulmonary hypertension confirmed by right heart catheterization. Some heart, lung, clotting, smoking, allergy, or other health problems will prevent participation. Side effects may include cough, throat irritation, headache, flushing, nausea, dizziness and low blood pressure. Results will help show whether daily TPIP is an effective and safe treatment for this group of patients.

Contact UCCC CTO for Study Activation

Specific study details/protocols can be provided upon request

Afimkibart in Moderate Severe UC

This Phase 3 randomized study tests Afimkibart (RO7790121), an investigational antibody, versus placebo as a short induction treatment for people with moderately to severely active ulcerative colitis. The main goal is to see how many participants reach clinical remission at Week 12 and to measure healing of the colon with endoscopy and tissue tests. The study also looks at early symptom change (Week 2), pain, urgency, fatigue, quality of life, and safety up to about 30 weeks. Eligible adults must weigh at least 40 kg, be up to date on cancer screening, and have tried but not benefited from at least one standard UC therapy. People with certain infections, recent cancers, specific types of colitis, pregnancy, or prior anti‑TL1A treatment are not allowed to join.

Freiermuth ALTO

Decrease the overall morphine milliequivalents administered to patients who present with femoral fracture or shoulder dislocation by 10% through expanded utilization of ultrasound-guided local anesthetic administration. Objective 1: By the end of year 2, 50% of faculty and residents will have performed a nerve block for one of the targeted conditions or completed training utilizing models through educational sessions led by ultrasound fellowship trained faculty Objective 2: Utilize research staff to screen the ED for eligible patients and remind the treatment team of protocols for ultrasound-guided blocks to increase uptake Objective 3: By the end of the project, perform nerve blocks for at least 50% of patients seen for femur fractures or shoulder dislocations, for a total of 311 patients treated Objective 4: Quarterly assess differences in amount of morphine milliequivalents administered to patients for femur fractures and shoulder dislocations among those who received a nerve block compared to those that did not to monitor impact of the program and guide educational and informational initiatives

Anticoagulation in ICH Survivors

The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke and recovery study is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high risk non valvular AF. A total of 700 patients, age 18 or older with a first ever ICH 14-120 days before entry will be randomized in a 1:1 ratio to receive apixaban ( 5 mg tablet twice daily or 2.5 mg tablets twice daily for patients meeting standard dose adjustment requirements) or aspirin (81 mg tablet once daily).

Brain and spine imaging before and after neck surgery for instability

This research study is looking at how advanced MRI scans can show changes in the brainstem and upper spine in people with craniocervical instability or a condition called basilar invagination. Participants will have MRI scans before surgery and again after surgery as part of their regular care, with one additional special scan. Researchers will compare these images to see how the spine and brainstem change after treatment and whether these changes relate to symptoms and recovery. The goal is to improve how doctors measure treatment success and better understand which patients may benefit from surgery.

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

Lumateperone Pediatric Bipolar Study

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study testing lumateperone in children and adolescents aged 10-17 who have bipolar I or II disorder and are currently in a major depressive episode without psychosis. After a screening period (up to 2 weeks) to confirm eligibility, participants are randomly assigned 1:1 to receive either lumateperone or placebo for 6 weeks while neither participants nor study staff know which treatment is given. About one week after the last dose, patients return for a safety follow-up visit. The main goal is to see if lumateperone improves depressive symptoms at week 6 (measured by a standard depression rating scale) and to monitor safety. Key eligibility points include a confirmed bipolar diagnosis, a recent depressive episode of at least 4 weeks, a history of at least one manic or hypomanic episode, and no high suicide risk or recent manic hospitalization.

Studying Airway Cells in the Lab

Adults having airway surgery may allow small cell samples to be collected and grown in the lab. This research helps scientists study airway diseases and test new treatments but does not change patient care.

Amivantamab added to carboplatin and pembrolizumab vs standard platinum regimens in treatment‑naive R/M HNSCC

This study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.

This study may be appropriate for those with: Metastatic Cancer

Cyclic Irrigation Expanded Access

This expanded access program offers the VT-X7 system, which delivers vancomycin and tobramycin by cyclic irrigation, to people having exchange surgery to treat a prosthetic joint infection (PJI) of the hip or knee who lack other treatment options. Eligible people are adults 22 to 84 years old who are scheduled for implant removal and who have a confirmed PJI. The program is for patients who may have failed prior exchange surgery. Certain people are not allowed to join, including those with recent bloodstream infection, infection in more than one joint, severe kidney disease, pregnancy, known allergies to the study antibiotics or certain implant materials, active cancer chemotherapy, high dose steroids, some immune problems, recent substance abuse, or other issues that would make study participation unsafe. Treatment involves the surgical removal of the prosthesis and use of the VT-X7 irrigation system during the exchange procedure, with hospital care and follow-up as directed by the study site. The aim is to give access to this antibiotic irrigation approach and to observe how well it is tolerated and works for these patients.

Understanding Social Factors and Infant Health Outcomes

This research study is trying to better understand how social factors like housing, income, transportation, and access to health care may affect infant health. The study includes people who give birth at University Hospital. Participants are asked to complete a survey after delivery. The information collected will be used to learn why some communities have higher rates of premature birth or infant death and to help guide future programs to improve infant health. There is no cost or risk to take part, and participation helps improve understanding of infant health in the community.

Mobile Intervention for Teen Suicide

This study is a double-blind, randomized pilot trial testing two smartphone-based digital programs to lower suicidal thoughts in teens. About 114 adolescents (ages 13-17) who were recently hospitalized after a suicide attempt or who have suicidal thoughts with a past attempt will join with a parent or guardian. Teens and parents, and the research staff who assess them, will not know which digital program the teen receives. The main goal is to see if suicidal thoughts improve over 12 weeks using a standard suicide ideation scale. Teens must have a smartphone and agree to allow one year of medical record review to track any suicide attempts after enrollment. The study screens out teens who are acutely intoxicated, in other similar trials, unable to follow procedures, have serious medical/psychiatric issues that make participation unsafe, or who will be transferred to another inpatient bed at discharge.

Understanding genetic Parkinson's disease

This study looks at people with a rare genetic form of Parkinson's disease and their family members. Researchers collect samples like blood, spinal fluid, and skin to better understand how the disease develops. The goal is to improve understanding of Parkinson's disease causes.

Icalcaprant in Bipolar Depression

This research tests an experimental pill called icalcaprant to treat depressive episodes in adults with bipolar I or II disorder. About 195 adults will be randomly assigned to one of three groups and will take either icalcaprant or a matching placebo once a day for 6 weeks. Neither participants nor staff will know who gets the real drug. After treatment, participants will have a 4-week safety follow-up. The study checks whether depression symptoms improve and records any side effects through medical assessments, blood tests, and questionnaires. Visits occur at study clinics and the number and schedule of visits depend on study procedures at each site.

Hypotension in PDD and DLB

Is hypotension the mechanism behind cognitive fluctuations in Parkinson's disease dementia and dementia with Lewy Bodies? The aim of the study is tp determine if the cortical electroencephalographic signatures of cognitive fluctuations are present in PDD and DLB patients with OH. We will use a tilt table test to determine if PDD/DLB patients with OH may have a differential electroencephalographic pattern than those without OH. Hypothesis: PDD and DLB patients with OH will have dominant frequency variability between alpha (8.0-12.0 Hz) and pre-alpha (5.5-7.5 Hz) bands compared with patients without OH.

Testing a New Combination Therapy for Advanced Lung Cancer

This study is looking at a new treatment combination for people with advanced lung cancer who have stopped responding to typical immune checkpoint inhibitors. The new combination includes the drugs N-803, tislelizumab, and docetaxel vs. just docetaxel alone, to see which is more effective in extending patients' lives. Adults 18 or older with this specific type of cancer could participate if they meet certain health requirements. Key aspects include the ability to follow the study procedures, managing contraception requirements, and having a specific level of health for various bodily functions. Some individuals will not qualify if they have recent treatments that conflict with the new drugs, have severe allergies to study drugs, or other significant health concerns.

This study may be appropriate for those with: Metastatic Cancer