Allina Health Cancer Institute (AHCI) clinical trials are available at Allina Health (Coon Rapids, Minneapolis, St. Paul) and Minnesota Oncology (Coon Rapids, Fridley, Minneapolis) 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). *Study pending at Minnesota Oncology locations.

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 unresectable, locally advanced or mTNBC (Phase 2 Cohort 1), magrolimab in combination with sacituzumab govitecan in patients with unresectable, locally advanced or mTNBC who have received 1 prior line of treatment in the unresectable, locally advanced or metastatic setting (Safety Run-in Cohort 2) (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: 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). *Study pending at Minnesota Oncology locations.

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-CD40 in combination with carbo, pemetrexed and pembrolizumab in subjects with stage IV non-squamous NSCLC (PI Amatruda).

Melanoma

 SGNS40-002: Phase 2, open-label study of SEA-CD40 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

Pacific Edge CXB/2019/US: Biospecimen collection of urine from patients presenting with hematuria for the determination of possible urothelial carcinoma using a multiplexed molecular biomarker test, Cxbladder ("STRATA Study") (PI Konety). 

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

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

OR

• Suspected 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
  • Cirrhosis

• 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 Bridge Line: 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

If you are interested in learning more about any Neuroscience Research trials, please contact the Neuroscience Research Team at NeuroscienceResearch@allina.com

 

Neuro-Oncology Research Trials:

GBM AGILE: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM).

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. 

More Information: https://clinicaltrials.gov/ct2/show/NCT03970447

 

DB102-01: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1.

Summary:

This randomized, multi-center phase III study will evaluate enzastaurin in comparison to a placebo, when added to radiation therapy and TMZ treatment. Eligible Glioblastoma (GBM) participants will be randomly assigned to one of the following groups:

• Radiation therapy + TMZ + enzastaurin
• Radiation therapy + TMZ + placebo

More Information: https://clinicaltrials.gov/ct2/show/NCT03776071

 

STaRT Registry: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms.

Summary:

This is a registry study aimed at evaluating real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of GammaTiles.

More Information: https://clinicaltrials.gov/ct2/show/NCT04427384

 

EF-32 (TRIDENT): A Pivotal, Radomized, Open-Label Study of OPTUNE® (TTFIELDS, 200KHZ) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma.

Summary:

This study is designed to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

More Information: https://clinicaltrials.gov/ct2/show/NCT04471844

 

Neuro-interventional Radiology Research Trials:

WEB-PAS: Post-Market Surveillance Study to Evaluate the Long Term Safety and Effectiveness of the WEB® Device.

Summary:

This is a Post-Market Surveillance study of the FDA-approved WEB Device. The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

More Information: https://clinicaltrials.gov/ct2/show/NCT04839705

 

THUNDER: Acute Ischemic Stroke Study with the Penumbra System® including Thunderbolt™ Aspiration Tubing.

Summary:

The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.

More Information: https://clinicaltrials.gov/ct2/show/NCT05437055

 

PRECISE: Perfusion imaging to identify posterior circulation candidates for thrombectomy

Summary:

Strokes are often caused by a blood clot inside a blood vessel that blocks the normal blood flow to a part of the brain; this type of stroke is called an ischemic stroke. The blockage can result in permanent brain damage. We are looking to enroll participants with an ischemic stroke due to a blockage of one of the vessels that supplies blood to the back of the brain. The purpose is to find out if advanced brain imaging can help identify which participants are most likely to benefit from a procedure to remove the blood clot to restore the blood flow to the brain.

 

Stroke Research Trials:

ARCADIA: AtRial Cardiopathy and Antithrobotic Drugs In prevention After cryptogenic stroke.

Summary:

ARCADIA is a phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years on this trial.

 

More information: https://clinicaltrials.gov/ct2/show/NCT03192215

 

ASPIRE: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery. [PI: Dr. Mark Young, Lead Coordinator: Kaitlin Lundell]

Summary:

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of apixaban (Eliquis®), compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF . Patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months.

More information: https://clinicaltrials.gov/ct2/show/NCT03907046

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