Clinical trials

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Allina Health Research is responsible for conducting clinical studies and collaborating with the community’s premier research houses to advance the treatment of our patients. We are committed to the improvement of patient care through discovery. 

Allina Health Research collaborates with various health organizations through a variety of clinical trials. With the help of these partnerships, Allina Health is able to create new avenues for treatment.

With over 600 research studies to date, our experienced researchers and collaborators take pride in bettering the medical community and enhancing population health in the communities we serve.

Current clinical studies

Breast cancer

Seattle Genetics SGN-LIV2 Triple Negative Study
Description: Phase 1b/2 Study of SGN-LIV1A + pembrolizumab for first-line treatment of unresectable locally-advanced or metastatic triple negative breast cancer
Locations: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Roche WO40181 HR+ Breast Cancer Study
Description: Phase II RCT of venetoclax + fulvestrant vs. fulvestrant in ER+, HER2 negative metastatic breast cancer after CDK4/6 inhibitor therapy
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital

Immunogen IMMU-132-09 Breast Cancer Study
Description: Phase 3 study of sacituzumab govitecan vs. physician’s choice in HR+, HER2 neg metastatic breast cancer following 2 prior chemo regimens
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Coming soon: Polyphor POL6326-009 HER2-Neg Breast Cancer Study
Description: Phase 3 study of balixafortide + eribulin vs. eribulin alone for HER2 negative, metastatic breast cancer
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Re-opening soon for new cohort: Seattle Genetics SGN-LIV1A Breast Cancer Study
Description: 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.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital

LAM 001-2018 ELITE Protocol (LAM is only looking for patients with active disease at this time.)
Description: Collection of blood from Healthy Patients, Patients with Benign Disease, and Patients with Cancer.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Colorectal cancer

LAM 001-2018 ELITE Protocol (LAM is only looking for patients with active disease at this time.)
Description: Collection of blood from Healthy Patients, Patients with Benign Disease, and Patients with Cancer.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Esophageal cancer

Takeda TAK-931-2001 Study
Description: Phase 2 study to evaluate TAK-931 single agent in pts with locally advanced or metastatic squamous esophageal cancer after first line tx formetastatic disease
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital

Gastric cancer

LAM 001-2018 ELITE Protocol (LAM is only looking for patients with active disease at this time.) 
Description: Collection of blood from Healthy Patients, Patients with Benign Disease, and Patients with Cancer.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Gynecology cancers (cervical and ovarian cancer)

Epicentrix Quadruple Threat
Description: Randomized 2:1 study of RRx-001 + carboplatin rechallenge followed by maintenance RRx-001/carboplatin vs. standard care therapy for epithelial ovarian cancer, fallopian tube or primary peritoneal cancer or malignant mixed mullerian tumor (MMMT) following first line platinum therapy
Location: Abbott Northwestern Hospital

Head and neck cancer

Rakuten Aspyrian Recurrent Head & Neck Cancer Study
Description: Phase 3 randomized open-label study of ASP-1929 photoimmunotherapy vs.physician's choice SOC for locoregional, recurrent head & neck squamous cell carcinoma on or after at least 2 prior lines of therapy
Location: Abbott Northwestern Hospital

Hepatobiliary cancer

Mayo Hepatobiliary Registry and Biorepository
Description: International registry of hepatobiliary cancers including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder adenocarcinoma, and unaffected individuals
Locations: Abbott Northwestern Hospital and Mercy Hospital – Mercy Campus

LAM 001-2018 ELITE Protocol (LAM is only looking for patients with active disease at this time.)
Description: Collection of blood from Healthy Patients, Patients with Benign Disease, and Patients with Cancer.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Lung cancer

Takeda TAK-931-2001 Study
Description: Phase 2 study to evaluate TAK-931 single agent in patients with locally advanced or metastatic squamous lung cancer after ≥ 2 lines of tx formetastatic disease
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital

Epicentrix Quadruple Threat  - Small Cell Lung Cancer 
Description: RCT of RRx-001 weekly x 6 followed by 6 cycles of platinum doublet, and maintenance RRX vs. RRx-001 weekly x 3 followed by platinum based chemotherapy + RRx-001 for up to 6 cycles and then RRX-001 maintenance
Location: Abbott Northwestern Hospital

Epicentrix Quadruple Threat - NSCLC 
Description: RCT of RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance vs. 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 platinum therapy
Location: Abbott Northwestern Hospital

AZ ADRIACTIC Limited Stage SCLC
Description: 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
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Lymphoma/Leukemia

Debiopharm 1562-201 NHL Study
Description: Phase 2 study of Debio 1562+ rituximab in relapsed/refractory DLBCL
Locations: Abbott Northwestern Hospital, Mercy Hospital

Trovagene TROV-052 AML Study
Description: Phase 1b/2 study of PCM-075 + low-dose cytarabine or decitabine in Acute Myeloid Leukemia
Locations: Abbott Northwestern Hospital

DeNovo DLBC Lymphoma DB102-02
Description: Phase 3 study ofenzastaurin + R-CHOP versus R-CHOP in treatment-naïve high-risk DLBC Lymphoma with genomic biomarker DGM1
Locations: Abbott Northwestern Hospital, Mercy Hospital

AZ Mantle Cell Lymphoma (MCL) SUMMIT Registry
Description: Registry study of patients who are initiating a novel agent for MCL to assess treatment patterns, response rates, PFS, and overall survival.
Locations: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Melanoma

BMS CA209-8FC Metastatic Melanoma Study
Description: 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
Location: Unity Hospital

BMS CA224-047 Melanoma
Description: Randomized, double blind study of relatlimab + nivolumab versus placebo + nivolumab in pts with previously untreated metastatic or unresectable melanoma
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus 

Neuroendocrine cancer

Epicentrix Quadruple Threat - Neuroendocrine Tumors
Description: 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
Location: Abbott Northwestern Hospital

Pancreatic cancer

Geistlich GP-2250 1001 Pancreas Cancer Study
Description: Phase 1/ 2 trial of GP-2250 + gemcitabine in metastatic pancreatic cancer who have progressed on FOLFIRINOX
Locations: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital

University of Minnesota Tissue Procurement Study
Description: Development of Oncolytic Adenovirus targeting cancer stem cells: Tissue procurement study from pancreatic or esophageal cancer surgery (Kamath/Kelsey 863-8716)
Location: Abbott Northwestern Hospital

LAM 001-2018 ELITE Protocol (LAM is only looking for patients with active disease at this time.)
Description: Collection of blood from Healthy Patients, Patients with Benign Disease, and Patients with Cancer.
Location: Abbott Northwestern Hospital, Mercy Hospital - Unity Campus, Mercy Hospital, United Hospital

Urothelial cancer
No trials available at this time.

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: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED)
Study summary: INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.
Contact: Adrienne Baranauskas, Adrienne.Baranauskas@allina.com, 612-863-0999; Jessi Whelan, jessica.whelan@allina.com, 612-863-7046
More information: https://clinicaltrials.gov/ct2/show/NCT02787044

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; Jessi Whelan, jessica.whelan@allina.com, 612-863-7046
More information: https://clinicaltrials.gov/ct2/show/study/NCT04032093

Study name: A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Study summary: The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
Contact: Adrienne Baranauskas, adrienne.baranauskas@allina.com, 612-863-0999; Jessi Whelan, jessica.whelan@allina.com, 612-863-7046
More information: https://clinicaltrials.gov/ct2/show/NCT03379675
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.

Play Long Study
Courage Kenny Rehabilitation Institute is conducting a 10-year longitudinal research study exploring the long-term impact of participating in adaptive sports and recreation for young children with disabilities.

Who is eligible to participate?
Parents of children who are between 5 and 8 years old and participate in adaptive sports or recreation.

Children who are between 5 and 8 years old, who participate in adaptive sport s or recreation and who have a disability.

Contact: Stacey Rabusch, research coordinator, 612-863-0882 or Nancy Flinn, principal investigator, 612-863-1418

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.

Contact: Stacey Rabusch, research coordinator, 612-863-0882

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

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

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