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Clinical Studies
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A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of Vilastobart (XTX101) Monotherapy and Vilastobart (XTX101) and Atezolizumab Combination Therapy in Patients with Advanced Solid Tumors
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.
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Gemini
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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Gemini Biorepository
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to develop a biorepository of blood samples from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.
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INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN) (INTERCEPTN)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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Novel Evaluation of Rectal Cancer with Diffusion-Weighted (DW) and Dynamic Contrast Enhanced (DCE) Perfusion Weighted Magnetic Resonance Imaging
Jacksonville, Fla.
The purpose of this study is to analyze the apparent diffusion coefficient (ADC) from Diffusion-Weighted (DWI) in patients before, during the second week of and after preoperative chemoradiation therapy for rectal cancer.
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The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-Free Survival in Patients with Locally Advanced Rectal Cancer (JANUS)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
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WO42758 - A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients with Metastatic Colorectal Cancer (Intrinsic) (Intrinsic)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
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A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer.
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A Phase 2, Randomized Study To Evaluate Safety, Efficacy, And Optimal Dose Of ABBV-400 In Combination With Fluorouracil, Folinic Acid, And Bevacizumab In Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.
Closed for Enrollment
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849-010 A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy (KRYSTAL-12)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
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A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer (FRESCO-2)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.
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A Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability,
Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination
with Other Anticancer Agents in Adults with Advanced Solid Malignancies
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations (BVD-523-ABC)
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to evaluate the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted.
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CL3-95005-007 - An Open-label, Randomised, Phase III Study Comparing Trifluridine/Tipiracil in Combination with Bevacizumab to Tifluridine/Tipiracil Monotherapy in Patients with Refractory Metastatic Colorectal Cancer (SUNLIGHT Study) (SUNLIGHT)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer (mCRC).
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Development of a rectal cancer specific organoid biorepository (PDTO)
Jacksonville, Fla.
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent’s Mayo Clinic Embedded Cancer Center (Inherit)
Jacksonville, Fla.
The goal of this study is to evaluate the integration of cancer genetic testing into a community cancer clinical practice aimed toward patients of various ethnic populations in north Florida including, but not limited to, African Americans, Hispanic/Latino, Native American/Alaskan and Asian, by self-report.
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MicroOrganosphereTM (MOS) Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
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Oberto-301, Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy After Progression on Anti-EGFR Therapy in Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (PULSE)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is: negative for RAS wild-type colorectal cancer and has spread to other places in the body, and/or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
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