This is a single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.

Type: Interventional

Start Date: Jul 2026

open study

The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study.

Type: Interventional

Start Date: Dec 2025

open study

Internal radiotherapies (radiolabeled molecules that are systemically administered and localize to sites of disease) provide cancer-ablating doses to diseased cells while sparing adjacent normal tissues. [223Ra]RaCl2 (Xofigo) is the first FDA-approved alpha-particle emitting radiopharmaceutical therapy (αRPT), providing a survival benefit for men with bone metastatic castration-resistant prostate cancer. Systemically administered radiotherapies distribute throughout the patient, accumulating to unknown levels at sites of disease and in radiosensitive vital organs. The whole-body distribution means that absorbed doses in the patient extend far beyond a pre-defined treatment field. There is a lack of information about αRPT distribution and localization, and this confounds treatment monitoring, complicates dose and schedule personalization, and impedes drug development. Single-photon emission computed tomography (SPECT) imaging offers a mechanism to quantify uptake; however, αRPT administered activities are significantly lower than those used with diagnostic procedures, which presents a challenge for quantitation with conventional methods. Preliminary research shows that low-count quantitative SPECT (LC-QSPECT) imaging demonstrates reliable quantitation of regional uptake for αRPTs. The purpose of this study is to demonstrate the feasibility, tolerability and performance of LC-QSPECT imaging.

Type: Interventional

Start Date: Sep 2026

open study

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Type: Interventional

Start Date: Dec 2025

open study

CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.

Type: Interventional

Start Date: Aug 2026

open study

This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma

Type: Interventional

Start Date: Jan 2026

open study

The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.

Type: Interventional

Start Date: Dec 2025

open study

This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.

Type: Interventional

Start Date: Nov 2025

open study

The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

Type: Interventional

Start Date: Dec 2025

open study

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

Type: Interventional

Start Date: Nov 2025

open study

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Type: Interventional

Start Date: Dec 2025

open study

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Type: Interventional

Start Date: Apr 2025

open study

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.

Type: Interventional

Start Date: Apr 2025

open study

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate. In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to: - Arm 1 (de-POACRT-42 Gy) - Arm 2A (de-POART-42 Gy) - Arm 2B (de-POART-37.8 Gy) - Arm 2C (de-POACRT-30 Gy). All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.

Type: Interventional

Start Date: Apr 2025

open study

VEXAS (vacuoles, E1 ubiqutin-activating enzyme, X-linked, autoinflammatory, somatic syndrome) is a recently described disorder with severe hematologic and rheumatologic manifestations caused by somatic variants in the ubiquitin- activating enzyme gene, UBA1, that is acquired in hematopoietic progenitor cells. Patients are often debilitated by autoinflammatory symptoms and there is currently no standard of care available. There is a clinically unmet need for better therapies in VEXAS Syndrome. There have been no prospective clinical trials of JAK-I in VEXAS syndrome. The investigators hypothesize that pacritinib, as a JAK2/IRAK1 inhibitor with a manageable safety profile in myelofibrosis patients with thrombocytopenia, will improve the autoinflammatory and hematologic manifestations of VEXAS syndrome with a tolerable toxicity profile. The investigators propose a single arm, pilot Phase 1 study evaluating the safety and tolerability of pacritinib in patients with VEXAS syndrome with an initial safety run-in phase of 6 patients treated with pacritinib 200mg twice daily (BID) on days 1-28 of a continuous 28 day cycle. If no more than 1 patient experiences a dose-limiting toxicity (DLT), the investigators will enroll an expansion cohort to gain additional toxicity and efficacy data, for a total enrollment of 15 patients. If more than 1 patient experiences a DLT during the safety run-in phase, the investigators will decrease the dose to 100 mg BID, and if no more than 1 of 6 patients experiences a DLT, the investigators will complete the expansion cohort as above for up to a total enrollment of 15 patients. If more than 1 patient experiences a DLT at 100 mg BID, the investigators will discontinue the study. Patients will be treated for up to 12 cycles.

Type: Interventional

Start Date: Feb 2025

open study

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Type: Interventional

Start Date: Apr 2024

open study

This is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (IV) infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 5 cohorts in this study. Cohort 1 will include participants 4 to < 7 years of age. Cohort 2 will include participants 7 to < 12 years of age. Cohort 3 will include participants 0 to < 4 years of age. Cohort 4 will include participants 12 to < 18 years of age. Cohort 5 will include participants 10 to < 18 years of age. Initiation of participant enrollment in Cohorts 4 and 5 will be subject to the accrual of safety and efficacy data from Cohorts 1-3. All participants will receive SGT-003 and will be enrolled in the study for 5 total years for long-term follow up.

Type: Interventional

Start Date: May 2024

open study

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Type: Interventional

Start Date: Jul 2024

open study

The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.

Type: Interventional

Start Date: Nov 2023

open study

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).

Type: Interventional

Start Date: May 2023

open study

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

Type: Interventional

Start Date: Dec 2022

open study

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.

Type: Interventional

Start Date: Nov 2024

open study

Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.

Type: Interventional

Start Date: Mar 2022

open study

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).

Type: Observational

Start Date: Nov 2020

open study