医疗专业人员

下面列出了当前开展的临床试验。

根据地点、状态和其他条件对此研究列表进行过滤。

1. Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

   Jacksonville, Fla.

   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.

2. Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

   Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Albert Lea, Minn.

   The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.

3. A Study to Test the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

   Rochester, Minn., Eau Claire, Wis., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

4. Efineptakin alfa (NT-I7) Plus Pembrolizumab for the Treatment of Recurrent Glioblastoma

   Rochester, Minn.

   The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.

5. Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)

   Rochester, Minn.

   The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).

   The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).

6. A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

   Rochester, Minn., Jacksonville, Fla.

   This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

7. DNA Methylation in Adenocarcinoma of the Prostate: Tissue Validation of Biomarkers and Pilot Testing in Blood

   Rochester, Minn.

   The study will be performed in two phases:  Phase I will be performed for biologic validation of marker candidates from a discovery cohort and phase II will be performed to evaluate the discrimination (sensitivity/specificity) of best candidate markers when assayed from blood of cases with CAP and controls without history of cancer. 

8. A Study of Nab-Paclitaxel as Maintenance Treatment After Cisplatin-Based Chemotherapy and Surgery for Patients with High-Risk Bladder Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate nab-paclitaxel as maintenance therapy after cisplatin-based chemotherapy and surgery in treating patients with high-risk bladder cancer. Maintenance therapy, such as paclitaxel albumin-stabilized nanoparticle formulation, can help keep cancer from coming back after it has disappeared following initial chemotherapy.

9. A Study to Evaluate Acalabrutinib With or Without Obinutuzumab to Treat Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   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.

10. First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

    Rochester, Minn., Jacksonville, Fla.

    The primary objective of this study is to determine the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) in patients with higher sodium-dependent phosphate transport protein 2b (NaPi2b) expressing platinum-resistant high-grade serous ovarian cancer (HGSOC), including cancers of ovarian, fallopian tube or primary peritoneal origin)

    Note: Mayo Clinic is only participating in the Phase 2 - Cohort 3 (UPLIFT) portion of the study. Mayo Clinic will not be participating in the QTC sub-study.