Dermatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Innovative CAR-TIL Immunotherapy Against Melanoma

   Jacksonville, Fla.

   The chimeric antigen receptor (CAR) T-cell therapy is a revolutionary cellular immunotherapy strategy that has transformed the treatment of B cell malignancies by engineering T cells to recognize B cell specific tumor markers; however, attempts to treat solid tumors with CAR T-cells have identified unique challenges that have rendered CAR T cells less effective against these tumors. Conventional CARs are designed to target tumor-associated antigens, but antigenic heterogeneity and the variable nature of surface antigen expression provide escape mechanisms for solid tumors from CAR T-cell attack. [1, 2] The solid tumor stroma acts as an immunosuppressive cloud that impedes the homing of peripheral CAR T-cells into the tumor microenvironment (TME). The hostile TME can also drive CAR T-cells to functional exhaustion and metabolic dysfunction, thus blunting the therapeutic efficacy of CAR T-cells.[3] Oncolytic viruses or radiation that generate local inflammation in the TME have been shown to promote T cell homing and infiltration [4] but do not address the exhaustion of tumor infiltrating lymphocytes (TILs). The PD-1/PD-L1 cascade allows tumors to evade the immune system by suppressing T cell function within the TME. [5, 6] An ideal adoptive cellular therapy must possess the ability to not only return to the site of the tumor but must also retain cytotoxic potential after a recognition event. We present here a CAR design that allows PD-1 to recognize PD-L1 on the tumor; however, the intracellular CAR design is one that results in T cell activation as opposed to inhibition. We hypothesize that targeting melanoma with a PD-1 (MC9324) CAR TIL therapy would capitalize on the tumor homing machinery of the TIL to drive the CAR TIL to the tumor where engagement of the PD-1 domain of the CAR with PD-L1 on the tumor cell would result in T cell cytotoxic killing.

2. A Study to Evaluate Perceptions of Midline Sternotomy Scar in Children and Young Adults

   Rochester, Minn.

   The purpose of this study is to evaluate how children and young adults perceive their midline sternotomy scars (in terms of appearance, associated symptoms, consciousness, satisfaction with appearance/symptoms, and impact on quality of life)? 

3. Superficial Dermal Capillary Plexus Oxygen Distribution In Health And Disease Using ODI DRS And CAM

   Rochester, Minn.

   The purpose of this study is to assess clinical feasibility and patient experience with non-invasive computer-assisted video microscopy (CAM) and diffuse reflectance spectroscopy (DRS) of the superficial dermal vessels using ODI technology. Anatomically map nutritive capacity of the superficial dermal microcirculation at various parts of the body (namely, various locations on the lower extremity [including at several arteriosomes), upper chest, and upper extremity] in healthy volunteers and in patients undergoing standard-of-care non-invasive arterial studies for any clinical indication. Correlate results with other variables, such as patient age, sex, tobacco use/diabetes status, anatomic location of testing, degree of edema, and results of non-invasive arterial studies. Generate hypotheses for specific future scientific inquiry based on preliminary findings from the work completed in aims 1-3.

    

4. BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib And Nivolumab) To Treat Patients With Advanced Melanoma Or Squamous Cell Head And Neck Cancer, An ImmunoMATCH Pilot Study

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

   The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.

5. Gemini Study To Evaluate The Integration Of Cancer Genetic Testing Into A Cancer Clinical Practice At Mayo Clinic At Arizona

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.

6. RLY-2608-201-Ph2 Study Of RLY-2608 In PROS And PIK3CA Driven Malformations

   Rochester, Minn.

   The purpose of this study is to compare the efficacy and safety of RLY-2608 versus placebo in adult, adolescent, and pediatric participants with PROS and malformations driven by PIK3CA mutations, which is preceded by a dose selection and basket design with exploratory single-arm cohorts for various subpopulations of participants.

7. Spatial And Multiomic Profiling Of Atopic Dermatitis

   Rochester, Minn.

   The purpose of this study is to evaluate key clinical, microbial, histological, and skin imaging biomarkers in patients with moderate-to-severe atopic dermatitis and perform comprehensive molecular profiling before and after treatment.

8. Circulating Tumor Nucleic Acids To Monitor Treatment Response In Metastatic Melanoma Patients

   Scottsdale/Phoenix, Ariz.

   This project will investigate whether the analysis of nucleic acids circulating in the blood from tumors can allow real-time monitoring of treatment response to targeted therapy and immunotherapy for patients who have stage IV metastatic melanoma.

9. Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program

   Jacksonville, Fla.

   This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.

10. A Study To Develop A Biorepository Of Blood Samples From Cancer Patients Participating In The Gemini (IRB 19-006717) Protocol

    Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    The purpose of this study is to develop a biorepository of blood samples  from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.