Clinical trials

Allina Health Cancer Institute (AHCI) clinical trials are available at Allina Health (Coon Rapids, Minneapolis, St. Paul) and MN Oncology (Coon Rapids, Fridley, Minneapolis, St. Paul) unless otherwise indicated.

Breast Cancer

HER2+

AZ Destiny D967RC00001: Phase 3 neoadjuvant study of T-DXd or T-DXd followed by THP compared to ddAC-THP in participants with high-risk HER2+ early-stage breast cancer (PI Perez).

Sea Gen SGNTUC-025 Metastatic HER2+ Breast Cancer Study: Phase 2 study of tucatinib + trastuzumab deruxtecan in previously treated (3rd line) unresectable mHER2+ breast cancer (PI Krie).

mTNBC 

Gilead GS-US-586-6144: Phase 2, randomized, open-label study of magrolimab in combination with nab-paclitaxel and paclitaxel versus nab-paclitaxel or paclitaxel in previously untreated mTNBC (PI Krie).

SGNLVA-001 (Part F): OPENING SOON - Phase 1, open-label study to evaluate the safety and tolerability of SGN-LIV1A in patients with 1st line PD-L1 low or negative locally advanced/mTNBC (PI Krie).

SGNLVA-002 (Part D): Single arm, open-label phase 1b/2 study of SGN-LIV1A in combination with pembrolizumab for first-line treatment of patients with unresectable locally advanced/mTNBC; requires PD-L1 Combined Positive Score (CPS) <10 (PI Krie).

Head & Neck Cancer

GS-US-548-5916: Phase 2 study of magrolimab combination therapy in patients with 1) untreated unresectable locally advanced/mHNSCC or 2) locally advanced/mHNSCC with 1-2 prior lines of therapy (PI Squillante). 

Lung Cancer 

AZ Compel D5162C00042: Phase 3, randomized, double-blind, placebo-controlled study of platinum plus pemetrexed chemotherapy plus osimertinib/placebo in patients with EGFRm, locally advanced/mNSCLC who have progressed extracranially following 1st line osimertinib therapy (PI Squillante).

AZ PAC8 D9075C00001: OPENING SOON - Phase 3, randomized, double-blind, placebo-controlled, multicentre, international study of durvalumab plus domvanalimab (AB154) in participants with locally advanced (stage 3), unresectable NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (PI Squillante).

Gilead GS-US-548-5918: Phase 2 study of magrolimab combination therapy in patients with mNSCLC & mSCLC with at least 1 prior line of systemic therapy (PI Squillante).

SGNS40-002: Phase 2, open-label study of SEA-CD4 in combination with carbo, pemetrexed and pembrolizumab in subjects with stage IV non-squamous NSCLC (PI Amatruda).

Melanoma

BMS CA224-098: Phase 3, randomized, double-blind study of adjuvant immunotherapy with relatlimab and nivolumab fixed-dose combination versus nivolumab monotherapy after complete resection of stage III-IV melanoma (PI Amatruda).

SGNS40-002: Phase 2, open-label study of SEA-CD4 in combination with pembrolizumab in subjects with metastatic uveal melanoma (PI Amatruda). 

Pancreatic Cancer

Geistlich GP-2250 1001 Pancreas Cancer Study: Phase 1 trial of GP-2250 + gemcitabine in subjects with advanced unresectable or metastatic pancreatic cancer who have progressed on FOLFIRINOX (PI Squillante). *Not available in St. Paul

Urothelial Cancer

Gilead GS-US-548-5918: Phase 2 study of magrolimab combination therapy in patients with mUC who have received 2-3 prior lines of systemic therapy (PI Squillante).

Other

Exact Sciences ASCEND2: Biospecimen collection to detect cancers earlier through elective plasma-based CancerSEEK testing in patients >50 years (PI Squillante).

• Untreated bladder, pancreatic, liver, uterine, stomach, ovarian, esophageal, HNSCC, thyroid, small intestine, cervical, anal, vulva, or testis.

OR

• Suspected pancreatic, bladder, kidney/renal pelvis, testicular or ovarian cancer. 

LAM 001-2018 ELITE Protocol: Biospecimen collection of blood from patients with cancer and/or benign disease (PI Squillante).

• Hepatic disease
  • Active HCC, includes all subtypes
  • Benign liver disease (i.e. cirrhosis, cysts, hepatitis)

• Colorectal disease
  • Active colon and rectal cancers, incudes all subtypes
  • Benign colon and rectal disease or genetic predispositions (i.e. cysts, benign tumors, IBS, Crohn's, ulcerative colitis, Lynch Syndrome)

If interested in more information regarding the previous studies, please call the Allina Health Cancer Institute Research Bridgeline: 612-863-8716

Metropolitan Heart & Vascular Institute

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

Allina Health Minneapolis Heart Institute

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, 651-241-2913651-241-2913
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, 651-241-2816651-241-2816
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, 651-241-2216651-241-2216
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, 651-241-2216651-241-2216
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, 651-241-2806651-241-2806
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, 651-241-2806651-241-2806
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, 612-863-0999612-863-0999; Jessie Whelan, jessica.whelan@allina.com, 612-863-7046612-863-7046
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, 651-241-7321651-241-7321
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, 612-863-3042612-863-3042
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, 612-863-3042612-863-3042
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, 612-863-3452612-863-3452
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, 612-863-3042612-863-3042
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, 612-863-3308612-863-3308
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, 612-863-3042612-863-3042
More information: https://clinicaltrials.gov/ct2/show/NCT03970447

No current clinical trials.

Thank you for your interest in our studies. All recruitment for studies is currently suspended due to COVID-19. Please check back for updates.

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, 952-914-8594952-914-8594; Katie Sjostrom, katie.sjostrom@allina.com
More information: https://clinicaltrials.gov/ct2/show/NCT02047955