Cancer

Below are current clinical trials.

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1. SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

   Jacksonville, Fla.

   The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd. 

2. A Study to Evaluate the Combination of Selinexor with Pomalidomide and Dexamethasone +/- Carfilzomib to Treat Patients with Refractory Multiple Myeloma

   Rochester, Minn.

   The purpose of this study is to evaluate selinexor combined with carfilzomib, pomalidomide and dexamethasone or pomalidomide and dexamethasone for the treatment of relapsed refractory multiple myeloma.

3. A Study of Biomarkers to Predict Cancer Therapy-related Cardiotoxicity

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

   The primary purpose of this study is to collect Biospecimens from patients who developed chemotherapy related cardiac toxicity (CRCT) and patients who are at a high risk for developing CRCT identified prior to the onset of therapy.

4. A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration

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

   The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.

5. Neoadjuvant Combination Targeted and Immunotherapy for Patients With High-Risk Stage III Melanoma

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this early phase I pilot trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating participants with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma.

   A third cohort of patients (Arm C) will receive tiragolumab and atezolizumab for neoadjuvant therapy, and atezolizumab alone for adjuvant therapy.

6. (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

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

   The purpose of this study is to identify a (Z)-endoxifen dose that achieves (Z)-endoxifen steady-state plasma concentrations (Css) between 500-1000 ng/mL. Dosing will begin with the (Z)-endoxifen 40 mg/day dose and may additionally explore either a lower (20 mg/day) or higher (80 mg/day) dose level based on (Z)-endoxifen Css as well as toxicity.

7. A Study to Analyze NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma

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

   The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I),  and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

8. Turkey Tail Mushrooms for women with ER+/HER2- Breast Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine changes in proliferation (Ki-67) in ER+HER2-breast cancers that receive turkey tail administration.

    

9. Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

   Rochester, Minn.

   The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.

10. A Study to Compare Two Surgical Procedures in Women With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

    Rochester, Minn.

    This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.