Clinical Trials

The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.

This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, 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. Radiation therapy uses high-energy x-rays to kill tumor cells ...

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...

The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.

The purpose of this study is to determine if the complete clinical response rate of patients with Stage I-IIIB (cT1-3, N0-1, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy is greater than 50%.

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...

This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.

To determine whether PET/MRI can accurately predict complete pathologic response from neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

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.

The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.

TREOS' Phase I clinical trial will investigate the safety, tolerability, and immunogenicity of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. This study will also explore the accuracy of prediction of pre-existing and newly induced CD8+ T cell responses in each patient using the PEPI Test and T lymphocyte infiltration detected in accessible biopsy sites.

The purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with CRC.

This study will assess the efficacy and outcomes of PD-1 blockade in patients with mismatch repair deficient colorectal cancer.

The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.

This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.

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.

The primary purpose of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

The purpose of this study is to compare hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). 

The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or ...

This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.

The aims of this study are to increase the number of Black consultants at MCA, make a meaningful impact on interactions among staff, leadership, and patients, and increase the number of Black staff in leadership roles beyond Diversity and Inclusion efforts.

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

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.

The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.

This is an open label study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.

The purpose of this study is to collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.

The primary aims for this study:

1. To select an optimal panel of novel MDMs for detection of recurrent or metastatic CRC and to assess MDM panel accuracy (sensitivity & specificity) for this application.

2. To evaluate the ability of the plasma MDM assay to predict CRC recurrence when tested serially following curative resection of CRC metastases.

The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.

This is a phase II trial that will study how well tucatinib (ONT-380) and trastuzumab work in treating patients with colorectal cancer with a specific genetic marker (human epidermal growth factor receptor 2 - HER2) that has spread to other places in the body or has come back and cannot be removed by surgery. Tucatinib has been found to specifically target and inhibit HER2.

The purpose of this study is to see how the DNA methylation (a biochemical process involved in cell development) is activated during initial tumor growth and tumor progression. In order to look at this in patients with colorectal cancer or adenoma we must look at their tissue collected during surgery. Fresh tissue is required in order to study the primary cells in culture.

This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC), and consists of Part A (dose regimen finding), followed by Part B (dose expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A.

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.

The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.

This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.

The primary purpose of this study for Step 1:

• To determine the RP2D of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.

The primary purpose of this study for Step 2:

• To assess the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. 

The primary purpose of this study is to confirm the specificity of a multi-target stool DNA test, Cologuard, in an average risk population, ages 45-49.

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.

The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.

PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.

Participants will receive TAS-102 and PolyPEPI1018 which ...

The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).

This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.

The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.

In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.

The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).

The primary purpose of this study is to confirm the specificity of a multi-target stool DNA test, Cologuard, in an average risk population, ages 45-49.

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.

The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

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).

In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...

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.

The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). 

The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...

The purpose of this study is to evaluate the integration of cancer genetic testing into a cancer clinical practice aimed towards patients of various ethnic populations in Arizona and Florida – including, but not limited to, Hispanic/Latino, Native American/Alaskan, African American, and Asian by self-report. 

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.

The purpose of this study is to determine the performance of the Exact IBD-ACRN (inflammatory bowel disease-advanced colorectal neoplasia)surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease. Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within 120 days after enrollment.

The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).

This study is to define the safety profile and to determine the maximum tolerated dose (MTD) and preliminary efficacy of AbGn-107 administered every 28 days (4 weeks) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic adenocarcinoma.

The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.

In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.

This study aims to evaluate the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.

The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.

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 ...

The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).

This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.

This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.

The purpose of this study is to estimate the impact of a 6‐week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects..

The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.

This study seeks to evaluate the efficacy and tolerability of veliparib in combination with FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan. This is a blinded study such that the Investigator and Subject will be blinded but AbbVie will be unblinded.

The purpose of this study is to evaluate the clinical activity, safety and tolerability of etruma-based treatment combinations.

The purpose of this study is to compare the overall survival with ramucirumab combined with FOLFIRI or a placebo and FOLFIRI in patients who have metastatic colorectal cancer.

CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...

The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

The purpose of this registry at Mayo Clinic Jacksonville, is to keep a database and biospecimens of all patients treated surgically and non-surgically for a gastro-enteropancreatic mass or a suspected metastatic lesion from a gastro-entero-pancreatic primary. This registry will keep demographic, clinical and pathologic data on each patient as well as follow-up information on outcome endpoints such as death and recurrence of disease, blood cell samples, and tissue samples from surgically removed tumors.

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.  

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.

The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer

The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.

The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.

The purpose of applying to the Institutional Review Board (IRB) for the collection of GI-related tissue is to enable comprehensive molecular investigations into the mechanisms underlying gastrointestinal cancers and diseases.

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy

The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.

The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.

The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.

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="">

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.

The purpose of this study is to determine if WATS 3D (The Wide Area Transepithelial Sample with three dimension analysis) can be used to adequately sample the colon and identify dysplasia in patients with Irritable Bowel Disease (IBD) undergoing surveillance. 

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="">

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.

The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.

The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.

The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).

The purpose of this study is to show the quality of life and bowel function in patients who have been diagnosed with rectal cancer and are known to have Hereditary Nonpolyposis Colorectal Cancer (HNPCC), especially to make comparisons between clinical managements, family history, and health behaviors.

This is an open label, multi-center, Phase Ib dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX or FOLFIRI with and without bevacizumab, or regorafenib.

The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.

The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.

The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.

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.

The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

The purpose of the study is to:

• Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.  
• Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies. 
• Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field. 

The purpose for this study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.

The ultimate goal of this biobank will be to provide the resource to initiate an exploration of human saliva as a potential liquid biopsy for cancer detection and surveillance.

This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.

The purpose of this study is to evaluate the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

The primary objectives for this study are: 

• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status

• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status

• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status

• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status

• Percentage of screened subjects experiencing loss ...

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.

The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat when given in combination with pembrolizumab and chemotherapy. Once the recommended doses have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.

This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.

The purpose of this study is to characterize the safety and tolerability of combined treatment with mogamulizumab and nivolumab, and also determine the maximum tolerated dose and the recommended fixed dose for the treatment of patients who have locally advanced or metastatic solid tumors.

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.

The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.

The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...

The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.

This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.