Clinical trials

Clinical trials are available at Allina Health Cancer Institute Coon Rapids, Minneapolis, & St. Paul.

Breast Cancer 

AZ Destiny D967RC00001: Phase 3, randomized, 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).

Gilead GS-US-595-6184: Now open A randomized, open-label, phase 3 study of adjuvant sacituzumab govitecan and pembrolizumab vs treatment of physician’s choice in patients with TNBC who have residual disease after surgery and neoadjuvant therapy (PI Krie). 

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).

EMBER-4 J2J-MC-JZLH: A randomized, open-label, phase 3 study of adjuvant imlunestrant vs standard adjuvant endocrine therapy in patients who have previously received 2 to 5 years of adjuvant endocrine therapy for ER+, HER2- early breast cancer with an increased risk of recurrence (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 He). 

Hematologic Cancer

AbbVie M22-716: Phase 1, open-label study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in B-cell malignancies (PI He). 

Pfizer C4971006: Phase 1b/2, open-label study of PF-07901801 in combination with glofitamab after a fixed, single dose of obinutuzumab in participants with relapsed/refractory diffuse large B-cell lymphoma not eligible for stem cell transplantation (PI He).

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 Fares).

AZ PAC8 D9075C00001: Phase 3, randomized, double-blind, placebo-controlled, multicenter, 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 Fares).

MK-3475-D46-04: Now open Phase 3, randomized, open-label, multicenter, active-comparator-controlled clinical study of pembrolizumab (MK-3475) in combination with sacituzumab govitecan versus pembrolizumab (MK-3475) monotherapy as first-line treatment in participants with PD-L1 TPS greater than or equal to 50% metastatic non-small cell lung cancer (PI Fares).

MK-2870-007-01: Now open Phase 3, randomized, open-label study of MK-2870 in combination with pembrolizumab compared to pembrolizumab monotherapy in the first-line treatment of participants with metastatic non-small cell lung cancer with PD-L1 TPS greater than or equal to 50% (PI Fares).

Eli Lilly J3M-MC-JZQB: Now open A global pivotal study in participants with KRAS G12C-mutant, locally advanced or metastatic non-small cell lung cancer comparing first-line treatment of LY3537982 and pembrolizumab vs placebo and pembrolizumab in those with PD-L1 expression ≥50% or LY3537982 and pembrolizumab, pemetrexed, platinum vs placebo and pembrolizumab, pemetrexed, platinum regardless of PD-L1 expression (PI Fares).

Urothelial Cancer

Asieris YHGT-NP-01: Phase 1/2 open-label multicenter study to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab compared to tislelizumab alone as neoadjuvant therapy in patients with muscle invasive bladder cancer (PI Harder). 

Diagnostic Studies

Astrin 2021L0021: Non-therapeutic, proof of concept study seeking to detect and isolate circulating tumor cells from blood samples of stage 0-2 breast cancer patients with no prior treatment (Group A) followed by blood samples from additional solid tumor subjects currently on active treatment with evidence of disease (Group B) (PI He).

Exact Sciences ASCEND2 THR-CS-001: Biospecimen collection to detect cancers earlier through elective plasma-based CancerSEEK testing in patients >50 years (PI He).

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

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

• Healthy subjects without cancer.

Exact Sciences 2021-05: Whole blood and tumor tissue specimen collection from subjects who either have a diagnosis of cancer or recurrent cancer to evaluate biomarkers (PI Torgerson).

If you are 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.

No current clinical trials.

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, Randomized, 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.

If you are interested in participating in any Courage Kenny Research Studies, please contact CKResearch@allina.com

Current Studies List:

Clinical implementation of wearable sensors to measure dual-task motor function in individuals with mild traumatic brain injury. [Principal Investigator: Margaret Weightman, PT, PhD]

The utility of sensor-based dual-task assessments has been established, but has not yet been translated into standard clinical practice. This study seeks to determine whether a Physical Therapist can reasonably conduct these sensor-based assessments in traditional PT clinical sessions. 

Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion (PSC). [Principal Investigator: Mary Radomski, PhD, OTR/L]

A team composed of researchers from Courage Kenny Rehabilitation Institute (CKRI) propose to recruit a sample of individuals experiencing persistent symptoms after concussion to evaluate the efficacy of administering the Compass Course to a novel population, to improve psychological well-being, engagement in everyday activities, and purpose in life.

MENTOR - A MNSCIMS Project. [Principal Investigator: Amanda DeRasmi, DO]

As part of the MNSCIMS consortium, Courage Kenny Research is operating the MENTOR project, which seeks to validate a clinical tool to describe bowel dysfunction in the inpatient rehabilitation setting and facilitate management across the first-year post-injury.

Minnesota Regional Spinal Cord Injury Model System of Care. [Principal Investigator: Mary Radomski, PhD, OTR/L]

Courage Kenny Rehabilitation Institute has recently been designated as part of the Minnesota Regional Spinal Cord Injury Model Systems. This is one of 14 U.S. spinal cord model systems of care that received 5-year research funding from the U.S. Department of Health and Human Services National Institute on Disability, Independent Living, and Rehabilitation Research. 

Purpose in Life Survey. [Principal Investigator: Mary Radomski, PhD, OTR/L]

Courage Kenny Research is investigating the Purpose in Life status in three different clinical populations, to see if novel cohorts can be investigated in future Purpose-driven interventions.Recruitment is currently occurring by invitation only. 

Reading after Traumatic Brain Injury: Preliminary Development of a Guiding Model for Assessment and Treatment. [Principal Investigator: Katy H. O'Brien, PhD, CCC-SLP]

Adults with traumatic brain injury are being invited to participate in a study which looks at the reading experiences of patients with TBI. In particular, this project looks to describe the reading experiences of adults with TBI, including habits, barriers, and facilitators.

Safe and Effective Shoulder Exercise Training in Manual Wheelchair User’s with SCI. [Principal Investigator: Margaret Weightman, PT, PhD]

This pilot study looks at the utility of a biomechanically-focused exercise intervention for manual wheelchair users with spinal cord injury. Participants will be randomized to one of two 12-week interventions, to determine whether a biomechanically-focused intervention will demonstrate improved short- and long-term outcomes. 

SENSE - Feasibility of using continuous, remote symptom monitoring to identify and respond to early fall-risk for patients with chemotherapy-induced peripheral neuropathy. [Principal Investigator: Laura Gilchrist, PT, PhD]

This study is looking at using remote symptom monitoring to determine the relationship between chemotherapy-induced peripheral neuropathy and fall risk. Participants treated at Allina Health will use a mobile ecological momentary assessment (mEMA) to provide real-time feedback on symptom status. 

Validity and Reliability of the Courage-Kenny Fibrosis Grading Scale for Post- Cancer Treatment Effects in Survivors of Breast and Head and Neck Cancer. [Principal Investigator: Margaret Weightman, PT, PhD]

The goal of this project is to refine and test the validity and feasibility of the Courage Kenny Fibrosis Grading Scale (CK-FGS), a test purported to quantify the degree of cancer-related tissue fibrosis experienced by those who have undergone surgery and radiation for various cancers. 

Provider Communication in Rehabilitation Open Patient Encounter Notes (ReOPEN): Application to Neurorehabilitation for Traumatic Brain Injury. [Principal Investigator: Katy H. O'Brien, PhD, CCC-SLP]

Electronic health record notes generated by healthcare providers are available for patients to read, with the goal of better understanding their care. This study develops a replicable methodology to evaluate stigmatizing language and linguistic complexity in rehabilitation notes, then extends this to characterize how people with brain injury, a population known to experience difficulty reading, react to and benefit from reading such notes.

Beyond Performance: Characterizing Changes in Cognitive Effort after Traumatic Brain Injury. [Principal Investigator: Natalie Covington, PhD, CCC-SLP]

Increased mental effort is often reported by people with a history of brain injury as a significant barrier to doing as much as they used to do before their injury. The goal of this project is to demonstrate that we can measure effort objectively and precisely using pupillometry and to identify how effort has changed as a result of brain injury.

Personalized Cognitive Rehabilitation: Validating a Brief Clinical Assessment of Multiple Memory Systems. [Principal Investigator: Natalie Covington, PhD, CCC-SLP]

Rehabilitation for brain injury requires learning and memory, but each person with TBI is different in terms of how their memory has changed. In this study, we are testing whether a set of novel memory tests can help us to predict what kind of treatment works best for individual people with TBI.

Score Agreement of Two Devices that Assess Readiness for Behind-the-Wheel Assessment for Persons with Acquired Brain Injury [Principal Investigator: Sharon Gowdy Wagener OTD, Co-Principal Investigator: Alisa Kocian, MA, OTR/l]

Courage Kenny Rehabilitation Institute is transitioning from using the Dynavision 2 to the Bioness Integrated Therapy System (BITS) as a tool to inform driving readiness recommendations related to visual-motor reaction time. At present, there is minimal research to inform score interpretation of the BITS related to community mobility. This research study will explore score agreement between the two devices to support further research and assist therapists in their assessment and recommendations for patients returning to safe driving.

 

 

No current clinical trials.

Utility of Intermittent Cryo-Compression versus Traditional Icing Following Arthroscopic Rotator Cuff Repair [Principal Investigator: L. Pearce McCarty III, MD, Co-Investigator: Lauren Zurek, MD]

 

The study proposes to evaluate the utilization of a non-invasive, novel cryo – compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. 

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
More information: https://clinicaltrials.gov/ct2/show/NCT02047955

Contact: Ned Tervola, ned.tervola@allina.com, 952-914-8594952-914-8594;