Breast Cancer

Merck MK-7339-009 Triple Negative Study: Open label, randomized Phase 2/3 study of olaparib + pembrolizumab vs. chemotherapy + pembrolizumab after induction of clinical benefit with first-line chemo + pembrolizumab for metastatic triple negative breast cancer (Tsai/Stephanie or Jen 612-863-5501)

Odonate Contessa Trio Triple Negative Phase 2 Study: Cohort 1 is a study of tesetaxel + 3 different PD-L1 Inhibitors for first line metastatic triple negative cancer, and Cohort 2 is for  tesetaxel monotherapy for first line metastatic HER2 negative patients who ≥ aged 65 (Tsai/Lori 612-863-1093)

Seattle Genetics SGN-LVA-002 Triple Negative Study: Phase 1b/2 Study of SGN-LIV1A + pembrolizumab for first-line treatment of unresectable, locally advanced or metastatic triple negative breast cancer.
Contact: Tsai/Jackie 612-863-3929

Roche WO40181 HR+ Breast Cancer Study: Phase II RCT of venetoclax + fulvestrant versus fulvestrant in ER+, HER2 negative metastatic breast cancer after CDK4/6 inhibitor therapy.
Contact: Tsai/Lori 612-863-1093

Immunogen IMMU-132-09 Breast Cancer Study: Phase 3 study of sacituzumab govitecan versus physician’s choice in HR+, HER2 neg metastatic breast cancer following 2 prior chemo regimens.
Contact: Tsai/Lori 612-863-1093

Polyphor POL6326-009 HER2-Neg Breast Cancer Study: Phase 3 study of balixafortide + eribulin versus eribulin alone for HR+/-, HER2 negative, metastatic breast cancer following 1-4 prior chemo regimens.
Contact: Tsai/Stephanie 612-863-1752

Seattle Genetics SGN-LIV1A Breast Cancer Study: Phase 1 study (Part E) of SGN-LIV1A for HR+/HER2-neg metastatic disease not eligible for further hormonal therapy. Must have progressed/relapsed after endocrine and CDK inhibitor and ≤ 1 prior cytotoxic therapy. Minneapolis, Fridley & Coon Rapids.
Contact: Tsai/Jackie 612-863-3929

LAM 001-2018 ELITE Protocol: Collection of blood from healthy patients, patients with benign disease and patients with cancer. LAM is only looking for patients with active disease at this time.
Contact: Tsai/Jennifer 612-863-5501

Colorectal Cancer

LAM 001-2018 ELITE Protocol: Collection of blood from healthy patients, patients with benign disease and patients with cancer. LAM is only looking for patients with active disease at this time.
Contact: Tsai/Jennifer 612-863-5501

Gastric Cancer

LAM 001-2018 ELITE Protocol: Collection of blood from Healthy patients, patients with benign disease and patients with cancer. LAM is only looking for patients with active disease at this time.
Contact: Tsai/Jennifer 612-863-5501

Head & Neck Cancer

Rakuten Aspyrian Recurrent Head & Neck Cancer Study: Phase 3 randomized open-label study of ASP-1929 photo-immunotherapy versus physician’s choice SOC for loco-regional, recurrent head & neck squamous cell carcinoma on or after at least 2 prior lines of therapy.
Contact: Kochuparambil/Stephanie 612-863-1752

Hepatobiliary Cancer

LAM 001-2018 ELITE Protocol: Collection of blood from Healthy patients, patients with benign disease and patients with cancer. LAM is only looking for patients with active disease at this time.
Contact: Tsai/Jennifer 612-863-5501

Lung Cancer

Takeda TAK-931-2001 Study: ON HOLD Phase 2 study to evaluate TAK-931 single agent in patients with locally advanced or metastatic squamous lung cancer after ≥ 2 lines of treatment for metastatic disease.
Contact: Tsai/ Jackie 612-863-3929

Epicentrix Quadruple Threat - NSCLC: RCT of RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance versus RRx-001 weekly until progression followed by up to 6 cycles of platinum doublet and then RRx-001 maintenance for patients with stable disease or better after first-line platinum therapy.
Contact: Tsai/Lori 612-863-1093

Epicentrix Quadruple Threat - Small Cell Lung Cancer: RCT of RRx-001 weekly x 6 followed by 6 cycles of platinum doublet and maintenance RRX versus RRx-001 weekly x 3 followed by platinum based chemotherapy + RRx-001 for up to 6 cycles and then RRX-001 maintenance for 3rd line or beyond that have previously received platinum or patients in 2nd line with platinum-refractory/resistant disease.
Contact: Tsai/Lori 612-863-1093

AZ ADRIACTIC Limited Stage SCLC: RCT of placebo-controlled consolidation treatment durvalumab or durvalumab and tremilimumab for patients with limited stage SCLC who have not progressed following concurrent chemoradiation therapy.
Contact: Leach/Jackie 612-863-3929

Lymphoma/Leukemia

Debiopharm 1562-201 NHL Study: Phase 2 study of Debio 1562+ rituximab in relapsed/refractory DLBCL. Minneapolis, Coon Rapids.
Contact: Tsai/Lori 863-1093

Trovagene TROV-052 AML Study: Phase 1b/2 study of PCM-075 decitabine in acute myeloid leukemia. Minneapolis.
Contact: Tsai/Stephanie 612-863-1752

DeNovo DLBC Lymphoma DB102-02: Phase 3 study of enzastaurin + R-CHOP versus R-CHOP in treatment-naïve high-risk DLBC lymphoma with genomic biomarker DGM1. Minneapolis, Coon Rapids.
Contact: Tsai/Lori 612-863-1093

AZ Mantle Cell Lymphoma (MCL) SUMMIT Registry: Registry study of patients who are initiating a novel agent for MCL to assess treatment patterns, response rates, PFS and overall survival.
Contact: Tsai/Janet 612-863-0171

Melanoma

BMS CA209-8FC Metastatic Melanoma Study: Phase 1 study to compare nivolumab drug product process D to nivolumab drug product process C in patients with Stage IIIa/b/c/d or Stage IV melanoma after complete resection.
Contact: Amatruda/Stephanie 612-863-1752

BMS CA224-047 Melanoma: Randomized, double blind study of relatlimab + nivolumab versus placebo + nivolumab in patients with previously untreated metastatic or unresectable melanoma.
Contact: Amatruda/Stephanie 612-863-1752

BMS CA209-76K Melanoma: Phase 3, randomized, double-blind study of adjuvant immunotherapy with nivolumab versus placebo after complete resection of Stage IIB/C melanoma.
Contact: Amatruda/Stephanie 612-863-1752

Neuroendocrine Cancer

Epicentrix Quadruple Threat - Neuroendocrine Tumors: Single arm study of RRx-001 weekly until progression followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance for patients with stable disease or better at discontinuation of platinum.
Contact: Tsai/Lori 612-863-1093

Ovarian Cancer

Epicentrix Quadruple Threat: Randomized 2:1 study of RRx-001 + carboplatin “rechallenge followed by maintenance RRx-001/carboplatin versus standard care therapy for epithelial ovarian cancer, fallopian tube or primary peritoneal cancer or malignant mixed mullerian tumor (MMMT) following first-line platinum therapy.
Contact: Tsai/Lori 612-863-1093

Pancreatic Cancer

Geistlich GP-2250 1001 Pancreas Cancer Study: Phase 1/ 2 trial of GP-2250 + gemcitabine in metastatic pancreatic cancer who have progressed on FOLFIRINOX.
Contact: Leach/Jackie 612-863-3929

University of Minnesota Tissue Procurement Study: Development of oncolytic adenovirus targeting cancer stem cells: Tissue procurement from treatment naïve pancreatic cancer surgery.
Contact: Kamath/Kelsey 612-863-8716

LAM 001-2018 ELITE Protocol: Collection of blood from healthy patients, patients with benign disease and patients with cancer. LAM is only looking for patients with active disease at this time.
Contact: Tsai/Jennifer 612-863-5501

Minneapolis Heart Institute Foundation

Learn more about the Minneapolis Heart Institute Foundation clinical trials.

Metropolitan Heart & Vascular Institute

Learn more about the Metropolitan Heart & Vascular Institute clinical trials.

United Heart & Vascular Clinic

Study name: Multicenter Imaging in Lead Extraction Study (MILES)
Study summary: The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.
Contact: Katie Bisch, katie.bisch@allina.com, 651-241-2913
More information: https://clinicaltrials.gov/ct2/show/NCT03772704

Study name: Reducing Lung Congestion Symptoms in Advanced Heart Failure (RELIEVE-HF)
Study summary: The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Contact: Katie Schwister, katie.schwister@allina.com, 651-241-2816
More information: https://clinicaltrials.gov/ct2/show/NCT03499236

Study name: The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (SAVAL)
Study summary: Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
Contact: Nikki Gernes, nicole.gernes@allina.com, 651-241-2216
More information: https://clinicaltrials.gov/ct2/show/NCT03551496

Study name: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)
Study summary: This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
Contact: Nikki Gernes, nicole.gernes@allina.com, 651-241-2216
More information: https://clinicaltrials.gov/ct2/show/NCT02922036

Study name: Narrow QRS HF Patients Assessed by ECG Belt
Study summary: The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.
Contact: Chris Brown, christopher.brown2@alllina.com, 651-241-2806
More information: https://clinicaltrials.gov/ct2/show/NCT03367104

Study name: ECG Belt vs. Echocardiographic Optimization of CRT
Study summary: Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
Contact: Chris Brown, christopher.brown2@alllina.com, 651-241-2806
More information: https://clinicaltrials.gov/ct2/show/NCT03305692

No current clinical trials.

Study name: A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Study summary: This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Contact: Adrienne Baranauskas, Adrienne.Baranauskas@allina.com, 612-863-0999; Jessie Whelan, jessica.whelan@allina.com, 612-863-7046
More information: https://clinicaltrials.gov/ct2/show/study/NCT04032093

Study name: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)
Study summary: Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
Contact: Kayla Stiernagle, kayla.stiernagle@allina.com
More information: https://clinicaltrials.gov/ct2/show/NCT03192215

Study name: Sleep for Stoke Management and Recovery Trial (Sleep SMART)
Study summary: The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.  
Contact: Bridget Ho, bridget.ho@allina.com, 651-241-7321
More information: https://clinicaltrials.gov/ct2/show/study/NCT03812653

Study name: Multi-arm Optimization of Stroke Thrombolysis (MOST) 
Study summary: The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.
Contact: Nilanjana Banerji, nilanjana.banerji@allina.com, 612-863-3042
More information: https://clinicaltrials.gov/ct2/show/NCT03735979

Study name: FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension (PILLAR-XT)
Study summary: The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH).
Contact: Nilanjana Banerji, nilanjana.banerji@allina.com, 612-863-3042
More information: https://clinicaltrials.gov/ct2/show/NCT03607825

Study name: Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms  
Study summary: This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. The SAFTE model will be used to assess cancer-related fatigue and study potential associations of change in sleep patterns to tumor recurrence in patients with high grade glioma. Data will be collected using the Readiband™ Sleep Tracker (https://www.fatiguescience.com/sleep-science-technology/). The Readiband device captures high-resolution sleep data, validated against the clinical gold standard of polysomnography with 92% accuracy. Sleep data is transmitted to the cloud automatically for SAFTE Fatigue Model analysis. We will correlate clinical progression data obtained from the patient's electronic medical record with SAFTE data.
Contact: Amy Ellenberger, amy.ellenberger@allina.com, 612-863-3452
More information: https://clinicaltrials.gov/ct2/show/NCT03877861

Study name: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)
Study summary: This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. 
Contact: Nilanjana Banerji, nilanjana.banerji@allina.com, 612-863-3042
More information: https://clinicaltrials.gov/ct2/show/study/NCT03149003

Study name: Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Study summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Contact: Meghan Hultman, meghan.hultman@allina.com, 612-863-3308
More information: https://clinicaltrials.gov/ct2/show/NCT02831959

Study name: Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (INTACT)
Study summary: Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.  Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.
The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment
More information: https://clinicaltrials.gov/ct2/show/NCT03393000

Study name: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE) 
Study summary: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. 
Contact: Nilanjana Banerji, nilanjana.banerji@allina.com, 612-863-3042
More information: https://clinicaltrials.gov/ct2/show/NCT03970447

No current clinical trials.

Development of Charge of Quarters Duty - Alternate Form Study

Funded by the U.S. Department of Defense

Help us research a way to get our soldiers safely back to duty after concussion. Soldiers need to have the ability to multi-task to help ensure they are safe during duty. Multi-tasking requires that a person shifts their focus back and forth between two or more activities. After a concussion, this can be difficult to do.

Courage Kenny Research Center helped develop a multi-tasking test for the U.S. Department of Defense and is looking for volunteers to participate in this study to help learn if it is effective.
Attend two testing sessions that last 1 – 1 ½ hours each at Mercy or Abbott Northwestern Hospital.

Receive $50 in gift cards in appreciation for your time.

For more information, contact: Ginger Carroll, research coordinator – 612-863-3262 

DoD4 ReTURN Study
Funded by the U.S. Department of Defense

Seeking active, healthy volunteers (both with and without a history of concussion) for a research study about performing thinking and turning activities at the same time. This study is designed to observe how people with continuing symptoms after a concussion are able to perform thinking and turning activities at the same time (dual –tasking). This is to help medical professionals know when it is safe for athletes to return to sport or U.S. military service members to return to duty.

Attend one study session at the Courage Kenny Research Center, located at Abbott Northwestern Hospital. Receive up to $75 in gift cards in appreciation for your time and contribution to this research.

Contact: Max Klaiman, research associate, 612-863-4088, or Maggie Weightman, PT, PhD, principal investigator, 612- 863-6525.

More information

Wheelchair Speed and Community Integration Study
Researchers at Courage Kenny Research Center would like to know more about how you move around in the community using your manual wheelchair.

Attend one, one-hour session at the Courage Kenny Rehabilitation Institute - Golden Valley. Receive a $20 gift card following the wheelchair handling evaluation in appreciation for your time.

For more information, contact: Stacey Rabusch, research coordinator, 612-863-0882

No current clinical trials.

Study name: Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients  
Study summary: The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products
Contact: Ned Tervola, ned.tervola@allina.com, 952-914-8594; Katie Sjostrom, katie.sjostrom@allina.com
More information: https://clinicaltrials.gov/ct2/show/NCT02047955