Sanford Health is the largest rural health system in the U.S., dedicated to transforming the health care experience and providing access to world-class health care in America’s heartland.
45 Hospitals
9 Countries
1 Phase 1 Center (Sioux Falls)
1 Transplant Center (Fargo)
4 Cancer Centers (Sioux Falls, Fargo, Bismarck, Bemidji)
4 MNCCTN Sites (Thief River Falls, Worthington, Ortonville, Bemidji)
50+ Open Pediatric Oncology Clinical Trials
300+ Open Adult Oncology Clinical Trials
170+ Oncology-Focused Clinical Investigators and Researchers
7 Primary Performance Sites Clinics/Hospitals
Sioux Falls
Worthington
Fargo
Bismarck
Bemidji
Thief River Falls
Ortonville
DISCOVERY IS THE FOUNDATION OF MEDICINE. WITHOUT IT, MEDICINE WOULD NOT EXIST. A SMALL QUESTION CAN GROW INTO AN ENORMOUS AMOUNT OF KNOWLEDGE.
HENCE, RESEARCH IS THE CORE OF WHAT WE DO. RESEARCH PREVENTS KNOWLEDGE FROM BECOMING STAGNANT AND ALLOWS MEDICINE TO CONTINUE TO EVOLVE.
- Daniel Almquist, MD Hematologist/Oncologist
SANFORD RESEARCH PROGRAM
From understanding the fundamentals of disease to developing the next generation of treatments, our team is on the path of innovation and bringing the world closer to a future where powerful healing overcomes any obstacle.
Primary Performance Sites
• Sioux Falls, SD
• Fargo, ND
• Bismarck, ND
• Bemidji, MN
• Worthington, MN
• Thief River Falls, MN
• Ortonville, MN
Comprehensive Program
State-of-the-art Research Facility
60,000-square-foot open collaborative research bay Advanced Therapeutics Program
Dedicated group of physician investigators, advanced practice providers, nurse navigator and research team
AAHRPP-accredited
In-House
Institutional Review Board
Maintains the highest ethical standards in protecting participants
Oncology Trials in 2024
• Over 6,300 analytical cases annually
• 3,452 total oncology enrollments:
• 3,304 NCI-funded
• 86 industry-sponsored
• 62 investigator-initiated
Biosafety Committee
Registered with the NIH and serves to review all research being conducted by Sanford Health involving recombinant or synthetic nucleic acids
Sanford BioBank
62,249 enrollments and 808,443 total research samples
Blood and Bone Marrow Transplant (BMT) Program
Offering autologous and allogenic BMTs. CAR-T cell therapy was added in 2023
BUILDING A ROBUST CANCER CLINICAL TRIALS PROGRAM IS CRITICAL TO ENSURE THAT ACCESS TO TRIALS
IS AVAILABLE FOR THOSE IN HISTORICALLY UNDERSERVED AREAS.
– Lora Black, RN, MPH Vice President, Clinical Research Sanford Health
PROGRAM
NATIONAL CANCER INSTITUTE COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP) SITE
Supported by the National Cancer Institute’s (NCI’s) Division of Cancer Prevention and Sanford Health
• One of 34 community programs
• Approximately 95 clinical trials open for patient enrollment at any given time
• Offers the unique opportunity to conduct clinical research in community practice and to evaluate oncology care models through cancer care delivery research (CCDR) trials
• Sanford NCORP was in the top three for treatment trial accrual and for cancer control, screening and prevention trial accrual
PIs: Daniel Almquist, MD (adult) Samuel Milanovich, MD (pediatrics)
CANCER PATIENTS SHOULD BE ABLE TO PARTICIPATE IN TRIALS AND HAVE ACCESS TO STATE-OF-THE-ART CARE CLOSE TO HOME, REDUCING BARRIERS SUCH AS TIME AWAY FROM THEIR FAMILY AND VITAL SUPPORT SYSTEMS. BY EXPANDING TRIAL AVAILABILITY, WE CAN MINIMIZE THEIR BURDENS.
– Jenna Hove, RN, BSN
Operations Director, Clinical Research
Sanford Health South Region
– Kathy Lancaster, BA
Operations Director, Clinical Research
Sanford Health North Region
AWARDS & RECOGNITION PROGRAM
NCI Connect NATIONAL CANCER INSTITUTE
New prospective cohort of 200,000 adults in the U.S., designed to further investigate the etiology of cancer and cancer outcomes, which may inform new approaches to precision prevention and early detection
Minnesota Cancer Clinical Trials Network
One of five health systems selected in collaboration with the Mayo Clinic Cancer Center and University of Minnesota Masonic Cancer Center
Launching preventive and therapeutic clinical trials at four Sanford Health outreach centers in Worthington, Thief River Falls, Ortonville and Bemidji
NCORP Network SANFORD NCORP OF THE CENTRAL PLAINS
Recognized with an award for overall accrual to cancer control and treatment trials
Certificate of Excellence
NCI CHILDREN’S ONCOLOGY GROUP (COG)
Recognized for the timely activation of CCDR studies, submission of data and for the quality of data submitted
National Accreditation Program for Breast Centers
American College of Radiology (ACR)
NRG Main Member Status
QOPI Certification Program
Commission on Cancer (CoC)
Alliance Member Status
College of American Pathologists (CAP)
National Consortium of Breast Centers
Designated Comprehensive Breast Imaging Center (CBIC)
12 GASTROINTESTINAL
14 GENITOURINARY
16 GYNECOLOGIC ONCOLOGY
18 HEAD AND NECK, MELANOMA AND RARE TUMORS
20 HEMATOLOGY
BREAST CANCER
FOCUS GROUP BREAST
Edith Sanford Breast Center
• Established in 2016 through a generous lead grant
• Leading the way in offering women the latest in national and international clinical trials
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Research staff presence at tumor boards to evaluate clinical trial eligibility
• Dedicated nurse navigators embedded in the clinic to allow for more timely diagnosis and coordination of services
Andrea Kaster, MD
Anu Gaba, MD
Allison Watson, MD, PhD
Amit Panwalkar, MD
Shelby Terstriep, MD
Key Clinical Trials
Merck MK3475-B49
• Phase 3, randomized, double-blind study
• Compares the efficacy of adding pembrolizumab to chemotherapy in HR+ and HER2+ metastatic breast cancer
PIs: Christopher Sumey, MD, and Amit Panwalkar, MD
CTSU S2212 (SCARLET)
• Phase 3 randomized study
• Compares early-stage, TNBC-receiving, anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab vs taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab
• Compares effectiveness of FDA-approved 2D and 3D mammography
PI: Daniel Almquist, MD
Celcuity CELC-G-301 (VIKTORIA-1)
• Phase 3, open-label, randomized two-part study
• Compares gedastolisib in combination with palbociclib and fulvestrant to standard care therapies in HR-Positive, HER2-negative advanced breast cancer patients
PIs: Allison Watson, MD, PhD, and Anu Gaba, MD
Alliance A012103 (OptimICE-PRC)
• Phase 3 randomized study
• De-escalation trial of therapy in early-stage TNBC patients who achieve pCR after neoadjuvant chemotherapy with checkpoint inhibitors
PI: Daniel Almquist, MD
CURRENTLY ENROLLING:
• MERCK MK3475-B49
• CTSU S2212 (SCARLET)
• CELCUITY CELC-G-301 (VIKTORIA-1)
• ALLIANCE A012103 (OptimICE-PRC)
THE
PRIMARY GOAL OF
OUR RESEARCH PROGRAM IS TO
BRING STATE-OFTHE-ART CARE INCLUDING CLINICAL TRIALS TO PATIENTS WHERE THEY ARE –IN THEIR OWN COMMUNITIES.
– Jonathan Bleeker, MD Hematologist/Oncologist
FOCUS GROUP GASTROINTESTINAL
Disease Associated Working Group
Enterprise-wide scheduled meetings with GI physicians discussing clinical practice as well as research opportunities and clinical trials
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient
• Specialized nurse navigators embedded into the gastrointestinal program, offering guidance to each patient from diagnosis through treatment
Systemwide Gastrointestinal Steering Committee
Jonathan Bleeker, MD
Amit Panwalkar, MD
Daniel Almquist, MD
Jeff Wiisanen, MD
CURRENTLY ENROLLING:
• MERCK MK1022-011
• ALLIANCE A022001 (COMPARENET)
• ALLIANCE A021806
• NSABP C-14 CORRECT-MRD II
Key Clinical Trials
Merck MK1022-011
• Phase 1/2 Study
• Evaluating the safety and efficacy of patritumab deruxtecan in gastrointestinal cancers
PI: Jonathan Bleeker, MD
Alliance A022001 (ComPareNET)
• Phase 2, randomized, prospective trial
• Evaluating lutetium Lu-177 dotatate PRRT vs capecitabine and temozolomide in well-differentiated pancreatic neuroendocrine tumors
PI: Daniel Almquist, MD
Alliance A021806
• Phase 3 trial
• Evaluating perioperative vs adjuvant chemotherapy for resectable pancreatic cancer
PI: Daniel Almquist, MD
NSABP C-14 CORRECT-MRD II
• Clinical validation study
• Predicting recurrence using a circulating tumor DNA assay to detect minimal residual disease in colorectal cancer patients
PI: Daniel Almquist, MD
THE IMPROVEMENT SEEN IN PATIENT OUTCOMES AS A RESULT OF ADVANCES IN TREATMENT WAS ONE OF THE MAIN REASONS I BECAME ON ONCOLOGIST. IT IS ESSENTIAL THAT WE CONTINUE TO PARTICIPATE IN CLINICAL RESEARCH TO IMPROVE THE LIVES OF ALL PATIENTS WITH CANCER.
– Jarrett Failing, MD Hematologist/Oncologist
FOCUS GROUP GENITOURINARY
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient
• Specialized nurse navigators embedded into the genitourinary program, offering guidance to each patient from diagnosis through treatment
1,000+
GENITOURINARY CANCER
CASES IN 2024
Jeff Wiisanen, MD
Christopher Sumey, MD
Jarrett Failing, MD
Key Clinical Trials
Alliance A031701
• Phase 2 study
• Comparing gemcitabine + cisplatin chemotherapy in patients with muscle-invasive bladder cancer with preservation for those patients whose tumor harbors deleterious DDR gene alterations
PI: Daniel Almquist, MD
Amgen 20180146
• Phase 1 study
• Evaluates the safety, tolerability, pharmacokinetics and efficacy of AMG 509 in metastatic castration-resistant prostate cancer (CRPR)
PI: Christopher Sumey, MD
Merck MK-6482-022 ccRCC
• Compares belzutifan (MK-6482) and pembrolizumab (MK-3475) vs a placebo and pembrolizumab in the adjuvant treatment of clear cell renal cell carcinoma (ccRCC) after nephrectomy
PI: Christopher Sumey, MD
CTSU S1823
Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors
• Prospective, observational study
• Assess miRNA 371 for outcome-positive prediction in patients with newly diagnosed germ cell tumors through an expression analysis
PI: Daniel Almquist, MD
CURRENTLY ENROLLING:
• ALLIANCE A031701
• AMGEN 20180146
• MERCK MK-6482-022 ccRCC
• CTSU S1823
300+
GYNECOLOGIC ONCOLOGY
CASES IN 2024
FOCUS GROUP
GYNECOLOGIC ONCOLOGY
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Research staff presence at tumor boards to evaluate for clinical trial eligibility
• Specialized nurse navigators embedded into the gynecologic oncology program, offering guidance to each patient from diagnosis through treatment
Sanford Teleoncology Program
• Achieved approval through the Gynecologic Oncology Group to enroll patients in underserved areas into various clinical trials through teleoncology
• Uses audiovisual conferencing technology to remotely connect patients to cancer specialists for consultations, second opinions, and patient monitoring and counseling
• Currently utilized in 15 locations
Kevin Byrd, MD
Maria Bell, MD
Michele Lohr, MD
Key Clinical Trials
GOG 3095/Merck MK2870-005
• Phase 3, randomized, active-controlled, open-label, multicenter study
• Comparing the efficacy and safety of MK-2870 monotherapy vs treatment of physician’s choice in participants with endometrial cancer
PI: Maria Bell, MD
GOG 3078/IMGN853-0421
• Phase 3, randomized, multicenter, open-label study
• Evaluating mirvetuximab soravtansine in combination with bevacizumab vs bevacizumab alone in maintenance therapy for patients with FRa-high recurrent peritoneal cancers
PI: Maria Bell, MD
GOG 3082/ACR-368-201
• Phase 1B/2 basket study
• Comparing monotherapy with a combination including gemcitabine for treatment of platinumresistant ovarian carcinoma, endometrial adenocarcinoma and urothelial carcinoma patients
CURRENTLY ENROLLING:
• GOG 3095/MERCK MK2870-005
• GOG 3078/IMGN853-0421
• GOG 3082/ACR-368-201
• GOG 3086/REFRaME-O1 STRO-002-GM3
PI: Maria Bell, MD
GOG 3086/REFRaME-O1 STRO-002-GM3
• Phase 2/3 open-label study
• Evaluating the efficacy and safety of luveltamab tazevibulin (STRO-002) vs investigator’s choice chemotherapy in women with relapsed platinumresistant epithelial ovarian cancer
PI: Maria Bell, MD
FOCUS GROUP HEAD AND NECK, MELANOMA AND RARE TUMORS
Active Biospecimen Repository
Multidisciplinary team heavily active in NCI studies
Steven Powell, MD
Daniel Almquist, MD Miran Blanchard, MD Jarrett Failing, MD
Mark Gitau, MD
Andrew Terrell, MD
Key Clinical Trials – Head and Neck
NRG HN005
• Phase 2/3 randomized study
• De-intensified radiation therapy for patients with early stage, P16-positive, non-smoking associated oropharyngeal cancer
• Compares maintenance nivolumab versus observation
PI: Daniel Almquist, MD
AstraZeneca eVOLVE HNSCC D798EC00001
• Phase 3 study
• Evaluating volrustomig (MDI5752) for participants with unresectable, locally advanced head and neck squamous cell carcinoma following definitive concurrent chemotherapy
PI: Steven Powell, MD
CURRENTLY ENROLLING:
• NRG HN005
• ECOG-ACRIN EA3161
• AZ eVOLVE HNSCC D798EC00001
• VYRIAD VYR-VSV2-203
• CTSU S2015
Key Clinical Trials – Melanoma
Vyriad VYR-VSV2-203
• Phase 2 study
• Advanced or metastatic melanoma
• Evaluates the antitumor activity and safety of Voyager V1 (VV1) in combination with cemiplimab
PI: Steven Powell, MD
CTSU S2015 (MelMarT)
• Phase 3, multicenter, multinational, randomized control trial
• Investigates 1 cm vs 2 cm wide excision margins for primary cutaneous melanoma
PI: Daniel Almquist, MD
HEMATOLOGY CASES IN 2024
FOCUS GROUP HEMATOLOGY
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient
• Specialized nurse navigators embedded into the program, offering guidance to each patient
Center for International Blood and Marrow Transplant Research (CIBMTR) membership
Seth Maliske, MD
Peter Kurniali, MD
Jonathan Bleeker, MD
Oluwatobi Odetola, MD
Blood Disorder and Bone Marrow Transplant Program
• 4 dedicated hematologists
• 4 advanced practice providers
• Dedicated BMT pharmacist
• Dedicated research staff
• Currently performing autologous and allogenic transplants and chimeric antigen receptor T-cell (CAR-T) therapy
• Focus on providing multidisciplinary care with dedicated team
• State-of-the-art cellular processing lab on campus
Dedicated space for BMT patients
• Positive pressure rooms with HEPA filters
• Dedicated infusion space for visits and treatment post-transplant to protect patients
Key Clinical Trials
Merck MK2140-010 (waveLINE-010)
• Phase 3, randomized, open-label, multicenter study
• Evaluating zilovertamab vedotin (MK-2140) in combination with R-CHP vs R-CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
PI: Jonathan Bleeker, MD
SWOG S2209
• Phase 3, randomized trial
CURRENTLY ENROLLING:
• MERCK MK2140-010
• SWOG S2209
• Evaluating newly diagnosed multiple myeloma (NDMM) patients considered frail or in a subset of “intermediate fit” comparing upfront three-drug induction regimens followed by double or single-agent maintenance
PI: Daniel Almquist, MD
LUNG CASES IN 2024
FOCUS GROUP LUNG
Integrated Team Approach
• Multidisciplinary review of cases
• Weekly tumor boards to review new and challenging cases
• Integration of clinical research staff to evaluate and offer clinical trial selection to every qualified patient
• Specialized nurse navigators embedded into the lung program, offering guidance to each patient from diagnosis through treatment
Daniel Almquist, MD Mark Gitau, MD Amit Panwalkar, MD
Allison Watson, MD, PhD
Christopher Sumey, MD
Steven Powell, MD
Key Clinical Trials
Merck MK2870-009
• Phase 3, randomized, open-label study
• Evaluating MK-2870 vs platinum doublets in participants with EGFR-mutated, advanced non-squamous non-small cell lung cancer who have progressed on prior EGFR tyrosine kinase inhibitors
PIs: Steven Powell, MD, and Mark Gitau, MD
Alliance A151216 (ALCHEMIST)
• Screening trial
• Looking at adjuvant lung cancer enrichment marker identification and sequencing in NSCLC of any histologic subtype and candidate for platinum doublet chemotherapy
PI: Daniel Almquist, MD
NRG LU007 (RAPTOR)
• Phase 2/3, randomized study
• Extensive stage SCLC
• Compares radiation therapy (RT) versus RT and atezolizumab
PI: Daniel Almquist, MD
SWOG LungMAP
• Master screening protocol
• Evaluating biomarker-driven therapies and immunotherapies in previously treated NSCLC
PI: Daniel Almquist, MD
Merck MK3475-U01 (KEYMAKER)
• Phase 1/2 umbrella study
• Rolling arms of investigational agents, pembrolizumab and chemotherapy alone or in combination in participants with NSCLC
PIs: Jeffrey Wiisanen, MD and Steven Powell, MD
Iovance IOV-LUN-202
• Phase 2 multicenter study
• Evaluating autologous tumor-infiltrating lymphocytes (LN145) in patients with metastatic non-small cell lung cancer
PI: Steven Powell, MD
Merck MK2870-019
• Phase 3, randomized, open-label study
• Comparing adjuvant pembrolizumab with or without MK-2870 in participants with resectable stage 2 to 3b (N2) NSCLC who do not achieve pCR after neoadjuvant pembrolizumab with platinum-based doublet chemotherapy followed by surgery
PIs: Mark Gitau, MD, and Steven Powell, MD
CURRENTLY ENROLLING:
• MERCK MK2870-009
• ALLIANCE A151216 (ALCHEMIST)
• NRG LU007 (RAPTOR)
• SWOG LUNGMAP
• MERCK MK3475-U01 (KEYMAKER)
• IOVANCE IOV-LUN-202
• MERCK MK2870-019
Sanford Children’s Hospital and Clinics
Sanford Health has been participating in pediatric oncology clinical trials for over 40 years
FOCUS GROUP PEDIATRICS
NCI Children’s Oncology Group
Sanford Health is a member of the largest childhood cancer research organization in the world with over 100 clinical trials. We have at least 30 Phase 2 and Phase 3 COG studies currently open and we were recognized for being a top-accruing NCORP site for adolescent and young adult (AYA) enrollments on COG trials
PIs: KayeLyn Wagner, MD, and Samuel Milanovich, MD
Disease Associated Working Group
Enterprise-wide scheduled meetings with pediatric oncology team to discuss clinical practice as well as research opportunities and clinical trials
Pediatric Tumor Board
Discuss and review new and challenging pediatric oncology cases
Distinguished Program
• Only pediatric oncology group in the Dakotas and western Minnesota
• Only hemophilia treatment centers in the Dakotas
ASCO TAPUR Study Molecular Tumor Board
Samuel Milanovich, MD – Member
Pediatric Cancer Data Commons Team
Aggregates diverse datasets to facilitate pediatric cancer research
Kirk Wyatt, MD – Co-investigator
KayeLyn Wagner, MD Kirk Wyatt, MD
Samuel Milanovich, MD
April Evans, MD
Catherine Nelson, DO
Key Clinical Trials
Sickle Treatment Outcomes Research in the Midwest (STORM 2.0)
• Collaborative effort to implement quality improvement projects and provider education initiatives to enhance access and delivery of care and outcomes
• Sickle cell disease in the Midwest
PIs: Jordan Doss, MD, and Samuel Milanovich, MD
SH Pediatric Oncologic Predisposition Study (POPS)
• Prospective genetic testing study
• Evaluates the number of pediatric oncology patients with AML, ALL, lymphoma, myelodysplastic syndrome or aplastic anemia that have a genetic predisposition to cancer
PI: Catherine Nelson, DO
Merck MK3475-051
• Phase 1/2 study
• Evaluating pembrolizumab in children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051)
PIs: Samuel Milanovich, MD, and KayeLyn Wagner, MD
CURRENTLY ENROLLING:
• STORM 2.0
• SH POPS
• MERCK MK3475-051
• MERCK MK9999-U01
• MERCK MK7684A-010
Merck MK9999-U01
• Phase 1/2 study
• Sub-study 01A: Evaluating the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors
• Sub-study 01B: Evaluating the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants with Hematological Malignancies or Solid Tumors
PIs: Samuel Milanovich, MD, and KayeLyn Wagner, MD
Merck MK7684A-010
• Phase 3, randomized, double-blind study
• Active comparator-controlled study of adjuvant MK7684A vs adjuvant pembrolizumab in participants with high-risk stage 2-4 melanoma
• Participants ages 12 and older
PIs: Jonathan Bleeker, MD, and Jarrett Failing, MD
ASCO TAPUR Review Board
Samuel Milanovich, MD, Anu Gaba, MD and Steven Powell, MD – Members
Steering Committee
Meets quarterly to improve strategies for gaining access to clinical trials that support genomic alterations and for the development of levels of evidence criteria
• Collaborative team of experts with experience in cancer and genetics develop a personalized care plan using genomic testing results
• Meets twice a week with an average of 10 cases formally presented each month
• Dedicated nurse navigator
• 111 cases presented in 2024
• 71 formally presented
• 40 informally reviewed
• Collaboration with Sanford World Clinic sites including Costa Rica and Ireland
Steven Powell, MD
Peter Kurniali, MD
Mark Gitau, MD
Jeff Wiisanen, MD
Anu Gaba, MD
Lior Borovik, MS
Samuel Milanovich, MD
Key Clinical Trials
Community Oncology Use of Molecular Profiling to Personalize the Approach to Specialized Cancer Treatment at Sanford (SH COMPASS)
• Enterprise-wide tracking of genomic testing use, collaborative testing review and subsequent treatment
• Focuses on delivering cancer treatment options tailored to a patient’s genomic profile
PI: Steven Powell, MD
ASCO Targeted Agent and Profiling Utilization Registry (TAPUR)
• Non-randomized clinical trial
• Evaluates the safety and efficacy of FDA-approved, targeted anticancer drugs prescribed for advanced cancer with a potentially actionable genomic alteration
PIs: Steven Powell, MD, Anu Gaba, MD, and Peter Kurniali, MD
ECOG-ACRIN EAY191 ComboMATCH Molecular Analysis for Combination Therapy Choice
• Non-treatment ComboMATCH registration trial, an informatics component for specimen and genomic data management, and multiple ComboMATCH treatment trials
PI: Daniel Almquist, MD
Amgen 19320210023 (MTAP)
• Phase 1/1b/2 study
• Evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
PI: Steven Powell, MD
CURRENTLY ENROLLING:
• SH COMPASS
• ASCO TAPUR
• ECOG-ACRIN EAY191
• AMGEN 19320210023
THROUGH OUR ADVANCED CANCER THERAPEUTICS PROGRAM, WE ARE ABLE TO OFFER OUR PATIENTS NOVEL TREATMENTS WHEN THEY MAY NOT HAVE OPTIONS AVAILABLE ELSEWHERE.
– Steven Powell, MD, FASCO Head of Enterprise Oncology Research, Medical Oncologist Sanford Health
FOCUS GROUP EARLY PHASE
Advanced Therapeutics Program
Program Highlights
• 4 physician investigators
• 2 dedicated advanced practice providers
• Dedicated nurse navigator
• Dedicated research team
• Opportunity for an overnight stay or extended lodging during trial participation
• Early phase clinical trials given priority in the study start-up process
Dedicated Space for Early Phase Trials
• 2 procedure rooms
• Spacious recovery room
• State-of-the-art research lab for specimen collection and processing
Recognized as a Regional Referral Hub
Physicians within and outside of Sanford Health refer cancer patients to Sanford Health
Steven Powell, MD
Maria Bell, MD Jonathan Bleeker, MD Christopher Sumey, MD
CURRENTLY ENROLLING:
• SAPIENCE THERAPEUTICS ST316-101
• SEAGEN SGNB6A-001
• BEIGENE BGB24714-101
• NANOBIOTIX 1100
• BMS CA233-000
Key Clinical Trials
Sapience Therapeutics ST316-101
• Phase 1/2 dose-escalation and expansion study
• Evaluating ST316 in subjects with selected advanced unresectable and metastatic solid tumors
PI: Steven Powell, MD
Seagen SGNB6A-001
• Phase 1, open-label, multicenter study
• Evaluates the safety, tolerability, pharmacokinetics and antitumor activity of SGN-B6A as monotherapy, in combination with pembrolizumab, and in combination with pembrolizumab and chemotherapy in adults with multiple disease-specific cohorts
PI: Steven Powell, MD
BeiGene BGB24714-101
• Phase 1 study
• Investigates the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of second mitochondrial-derived activator of caspases mimetic BGB-24714 as a monotherapy and with combination therapies in patients with solid tumors
PI: Steven Powell, MD
Nanobiotix 1100 Advanced Cancers
• Phase 1 study
• Evaluates NBTXR3 activated by radiotherapy for patients with advanced solid tumors treated with anti-PD-1 therapy
PI: Michele Lohr, MD
BMS CA233-000
• Phase 1/1b trial
• Evaluating BMS-986484 as monotherapy and combination therapy in participants with advanced solid malignancies
PI: Steven Powell, MD
UNDERLYING EVERY HUMAN DISEASE IS A BIOLOGICAL PROCESS THAT HAS GONE AWRY. DISCOVERING THOSE MECHANISMS AND THEIR MANIFESTATION IN DISEASE TO GENERATE NOVEL TREATMENTS LIES AT THE CORE OF ALL THAT WE DO.
– Michael Kareta, PhD
Associate Scientist, Genetics and Genomics
Sanford Health
FOCUS GROUP TRANSLATIONAL RESEARCH
Sanford Center for Cancer Biology Research
Awarded multiple grants through the National Institutes of Health’s Centers of Biomedical Research Excellence (CoBRE):
• Phase 1: A nearly $11.5 million grant to develop a group of basic science and translational cancer researchers
• Phase 2: A five-year, nearly $11.7 million grant to translate laboratory research into clinical trials for head and neck
• Phase 3: A $6.2 million grant to continue building research expertise in cancer biology
• Pilot awards include:
• Pilar de la Puente, PhD, Sanford Research –“Metabolic Labeling of Nascent Extracellular Matrix in Physiologically Relevant Preclinical Models TIME”
• Xiaojun Xian, PhD, South Dakota State University –“Point-of-care Assessment of Anticancer Drug Dosage for Evaluating the Efficacy of Cancer Treatment”
TRANSCEND Collaborative Translational Science Engaging North Dakota
Clinical and translational research development program (CTR-D) to expand C&T research focused on health problems in North Dakota.
• Elevates clinical and translational research across North Dakota, offers training and assistance to grow investigators, and makes an impact on the health of North Dakotans
• Three ongoing collaborative projects engaging Sanford Health clinicians with academic partners
Core Facilities
Located at the research centers in Sioux Falls, SD, and Fargo, ND, Sanford Research’s core facilities are led by highly trained staff and provide expertise, advanced techniques and cutting-edge technology for basic, translational and clinical research.
• Animal Behavior Core
• Behavior Economics Core
• Biochemistry Core
• Data Exchange Core
• Histology and Imaging Core
• Experimental Therapeutics Screening Facility
Key Clinical Trials
CD8+ T Cells in TME
• Prospective specimen collection study
• Aims to uncover how CD8+ T Cells dysfunction, driven by exhaustion and senescence, limits immune response in colon cancer
PI: Robert Sticca, MD
CTR CRC OBESITY
• Prospective specimen collection study
• Investigates novel pathways that accelerate the formation of benign and malignant tumors in obese and overweight patients for therapeutic strategies to prevent and treat obesity-associated colorectal cancer
PI: Jonathan Bleeker, MD
• Flow Cytometry Core
• Functional Genomics and Bioinformatics Core
• Research Design and Biostatistics Core
• Research Assessment Services Core
• Biomedical Statistics Core
• Human Subjects Core
SH TME
• Prospective specimen collection study
• Aims to validate a novel patient-derived 3D model as a tool to predict patient response to therapy to determine effective treatments and avoid treatment with drugs that ovarian cancer patients will be resistant to
PI: Pilar de la Puente, PhD
CTR PCA Bone Metastasis Testbeds
• Prospective specimen collection study
• Development of humanoid testbeds of prostate cancer at bone, lymph and liver metastases to recapitulate the environment for the purpose of testing drug therapies
PI: Parth Vyas, MD
SIOUX FALLS, SOUTH DAKOTA
Sanford Cancer Center
1309 W. 17th St. Sioux Falls, SD
SIOUX FALLS, SOUTH DAKOTA INVESTIGATORS
Maria Bell, MD
Gynecology
Jonathan Bleeker, MD
Gastrointestinal, Precision Oncology
Kevin Byrd, MD
Gynecologic Oncology
Jordan Doss, MD
Pediatric Hematology, Oncology
Jordan Fritch, MD
Pediatrics
Keely Hack, MD
Breast
Michele Lohr, MD
Radiation Oncology
Miroslaw Mazurczak, MD
Breast, CNS, NCORP
Steve McGraw, MD
Radiation Oncology
Catherine Nelson, DO
Pediatrics
Ryan Nowak, MD
Radiation Oncology
Christopher Sumey, MD
Lung, Genitourinary, Precision Oncology
Steven Powell, MD
Precision Oncology, Early Phase, Head and Neck
KayeLyn Wagner, MD
Pediatrics
Na Smith, MD
Radiation Oncology
Travis Snyders, MD
Hematology, Precision Oncology
Allison Watson, MD, PhD
Breast
FARGO, NORTH DAKOTA
FARGO, NORTH DAKOTA INVESTIGATORS
Daniel Almquist, MD
Gastrointestinal, Lung, Head and Neck, Precision Oncology
Mark Gitau, MD
Gastrointestinal, Lung, Head and Neck, Precision Oncology, Rare Tumor
Jessica Benjamin-Eze, DO
Pediatric Hematology, Oncology
April Evans, MD
Pediatric Hematology, Oncology
Jarrett Failing, MD Melanoma
Anu Gaba, MD
Breast, Precision Oncology
Mahendra Gupta, MD Gynecologic, Lung
Ash Jensen, MD
Radiation Oncology
Andrea Kaster, MD Breast
Seth Maliske, MD Hematology/ Oncology
Samuel Milanovich, MD
Pediatrics
Sommer Nurkic, MD Radiation Oncology
Oluwatobi Odetola, MD
Hematology, Oncology
Amit Panwalkar, MD
Breast, Gynecologic, Lung
Andrew Terrell, MD
Head and Neck
Shelby Terstriep, MD
Breast
Matthew Tinguely, MD
Gastrointestinal
Radhakrishna Vegunta, MD
Hematology/Oncology
Jeff Wiisanen, MD
Hematology/Oncology
sanfordresearch.org/clinicalresearch
Kirk Wyatt, MD
Pediatrics
INVESTIGATORS
BISMARCK, NORTH DAKOTA
Thandiwe Gray, MD
Hematology/Oncology
Peter Kurniali, MD
Hematology/Oncology
Aaron Luebke, MD
Hematology/Oncology
Baruti Serabe, MD Pediatrics
Sanford Medical Center
300 N. Seventh St. Bismarck, ND
Edward Wos, DO
Hematology/Oncology
INVESTIGATORS
BEMIDJI, MINNESOTA
Daniel
Almquist, MD
Gastrointestinal, Lung, Head and Neck, Precision Oncology
