Clinical Trials

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

This phase I trial studies the side effects and the best dose of trametinib when given together with combination chemotherapy and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving trametinib, combination chemotherapy, and radiation therapy may be a better treatment for non-small cell lung cancer.

This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

The purpose of this study is to determine the safety, tolerability, activity, and drug/body interactions of Oradoxel for the treatment of patients who have advanced malignancies.

Some patients with head and neck cancer caused by human papilloma virus have a higher risk of recurrence. We are proposing to treat these patients with HPV vaccine with or without pembrolizumab during the window prior to surgery, in hopes of stimulating an immune response.

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 this study is see if a new ultrasound-based technique similar to standard clinical echocardiography, called Shear Wave Elastography, can provide reliable early detection of heart muscle damage caused by chemotherapy.

The main objective of this study is to evaluate the effectiveness of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the effectiveness and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

**Please note that at Mayo Clinic, this study will only be enrolling in Part 2 of the trial and will not be enrolling adolescents. We will be enrolling adult subjects only. 

This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best

available treatment (BAT) in patients with AML in second complete remission (CR2)

or in second complete remission with incomplete platelet recovery (CRp2). All

patients will have their historical bone marrow samples stained for WT1 via IHC by

central pathology review. The primary goal of the study will be to demonstrate an

advantage for GPS in overall survival in these patient populations. The study will

enroll approximately 116 patients and will be conducted at up to 50 investigational

sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are

in CR2 or CRp2.

Patients on the BAT arm may be treated with 1. observation (whereby palliative

management with hydroxyurea is allowed), 2. a hypomethylating agent (decitabine or

azacitidine), and/or 3. Venetoclax and/or 4. low-dose ara-C. Patients whose

remission in CR2 that can be maintained with other agents (e.g. FLT-3 or IDH

inhibitors) will not be eligible. However, there are no restrictions on prior use of

any agents in the CR1 setting. Patients can not receive GPS as an adjunct therapy to

any other agents.

Patients on the GPS arm will receive 70 μg of sargramostim (GM- CSF) on Day -2

and Day 1 before each injection of GPS. The first two administrations of GM-CSF

will take place at the same anatomical site as the planned administration of GPS within

each treatment cycle. GPS will be administered as an immunization induction every

2 weeks for 6 administrations (Weeks 0 – 10); this will be followed by a 4-week

period of no treatment. Treatment will then resume for 6 administrations as an initial

booster phase every 4 weeks (Weeks 14 – 34) which will again be followed by a

period of no treatment lasting 6 weeks. GPS will be resumed after this period as a

second booster phase and will be administered every 6 weeks for 3 administrations

(Weeks 40 – 52). Following each administration of GM-CSF or GPS, patients will

remain in the clinic for approximately 30 minutes for observation. An End of

Treatment visit will be conducted 30 days following the last dose of GPS. Patients

will then enter the long-term follow-up portion of the trial where they will be followed

for recurrence of leukemia and overall survival.

To ensure a comparable level of observation, patients randomized to the BAT arm

will be seen every 4 weeks through Week 52. The Schedules of Procedures for both

the GPS and the BAT arms can be found in Section 6 of the protocol.

All patients will undergo bone marrow aspirates and biopsies at screening, Week 12

and end of treatment. Bone marrow examinations will then be repeated as clinically

indicated. Patients will be assessed for safety at each clinic encounter. The primary

endpoint will be overall survival.