Clinical Trials

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.

This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial.  Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary.  Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

Primary Goal

• To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.  

Secondary Goals

• To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
• To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

Exploratory Goals

• To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
• To evaluate changes in immune response with ICIs and multi-strain probiotic blend.

The purpose of Phase I of this study is to evaluate the safety and tolerability of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) / higher risk myelodysplastic syndromes (HR-MDS) / MDS/MPN to determine the recommended dose of CTX-712. The purpose of Phase II of this study is to assess the effiectiveness of CTX-712 in patients with R/R AML/HR-MDS by determination of complete remission (CR) rates.

The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.

This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.

Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, common iliac, obturator packet, retropubic and sacral.  Following surgery there will be an expert pathologic review of the sampled lymph nodes by a dedicated GU pathologist and a corresponding comparison with preoperative imaging and patient risk AUA prostate cancer risk score. 

Following surgery, participants will visit the study doctor for their standard follow-up visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months with corresponding PSA surveillance with adjuvant imaging or treatment as part of standard of care.

Proposed study is intended to be carried out at the Mayo Clinic in Jacksonville, Florida. Urologist Dr. Ram Anil Pathak will be the responsible Principal Investigator, primary surgeon, and counselor for the study patients. The PI and his assigned team will conduct the follow-up visits (6 weeks, 3-, 6-, 9- and 12-months) at the Urology Clinic of Mayo Clinic in Florida.

Patients will be assessed for safety by regular evaluation of adverse events (AE) as clinically indicated.

The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.

The purpose of this study is to determine how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas.

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug and fianlimab is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations

The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.