Clinical Trials

This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.

The purpose of this study is to understand if there are race-specific or other demographic-specific attitudes about voluntary testing for hepatitis B and C virus infection and return of individual research results that could have implication for an individual's risk of developing hepatitis-related liver cancer. Understanding these attitudes is a necessary first step to developing effective intervention strategies for liver cancer prevention.

The overall purpose of this study is to evaluate the safety and diagnostic effectiveness of Mangoral in liver MRI in patients with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

The purpose of this study is to compare the accuracy of non-invasive MRE (Magnetic Resonance Elastography) with the results of liver biopsy and/or MRI (Magnetic Resonance Imaging).

This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

The purpose of this study is to determine whether treatment with vaccinia virus based immune system therapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib alone in patients with advanced liver cell cancer, who have not received prior systemic therapy.

Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.

The purpose of this study is to investigate means to identify circulating tumor cells from the portal vein and hepatic vein blood of patients with liver cancer at the time of liver transplantation.

The purpose of this trial is to test whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...

The primary purpose of this study is to evaluate the safety of a viral agent called vesicular stomatitis virus for the use in patients with liver cancer. The study virus has a gene inserted into it which will allow for the production of interferon beta, which is a substance that will have the dual functions of restricting the spread of the virus to the tumor cells and not healthy liver cells and also to have some independent anti-cancer activity. Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients ...

This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted. 

The purpose of this study is to characterize the social determinants of health – and specifically travel-limiting access to cancer care but also other issues, such as trouble in finding childcare, joblessness, and limited education – among adults diagnosed with hepatobiliary cancers. In addition, we will also assess risk factors including aflatoxin exposure and hepatitis screening. The study involves administering a questionnaire to adults diagnosed hepatobiliary cancer patients and collect blood/buccal swab/urine for aflatoxin assessment.

The goal of this study is to develop a resource (bank) of biospecimens (blood, tissue) from patients having cancers that metastasis to the liver. The purpose of the resource bank is to facilitate studies on the pathogenesis of cancers metastasizing to the liver and also in order to assess the ability of new tests to detect early cancer in the cohort of patients undergoing routine surveillance for cancer. The biospecimens will include cultures of tumor cells and tumor-associated non-malignant cells, as well as xenografts established from freshly isolated metastatic cancers in immunodeficient mice. We plan to administer a risk factor ...

This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or those with liver metastasis from other cancers. The drug is given intravenously, twice per week for three weeks in a row and then one week off. Additionally patients with hematologic malignancies will be evaluated on a treatment schedule of five days in a row with two weeks off.

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary liver transplant are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.

The purpose of this study is to evaluate the use of the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.

The Patient Group 1 primary objective is to measure the distribution of 90Y glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day postradioembolization study-specific non-FDG PET/CT scan. Correlate this measurement with mean lobar absorbed radiation dose and embolic load given to patients and time taken to achieve adequate Future Liver Remnant (> 40% of total liver volume) to determine if there is an optimal lobar dose and embolic load.

The Patient Group 2 primary objectives are to assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy, and to assess progression-free survival between ...

This study is being done to collect and store samples of blood from patients with liver disease for a research study to be able to find a new and better way to detect liver cancer.

The purpose of this study is evaluation of tumoral markers at the time of transplant to assess recurrence risk, and assessment of tumor sensitivity to a panel of candidate therapeutics as a guide to adjunct or therapeutic therapies for recurrent hepatocellular cancers (HCC).  

The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.

The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.

The goal of the study is to identify immune responses (immune cell activation and suppression) following local ablation of liver tumors.

The purpose of this study is to investigate the value of ultrasound imaging of tumor microvasculature and stiffness as new biomarkers for evaluation of liver tumor.

The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...

The purpose of this study is to evaluate how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, 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. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.

The purpose of this study is to validate an NMR-based (Nuclear magnetic resonance) serum metabolite constellation for detection of early Hepatocellular carcinoma (HCC) lesions in liver cirrhosis.

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

The purpose of this study is to evaluate the usefulness of new markers found in blood that might help to diagnose of liver cancer (HCC) early among people with cirrhosis. We hope that this study will show that these new markers could identify HCC at an earlier stage where better treatment options are available.

The purpose of this study is to evaluate patient outcomes after undergoing 68Ga-PSMA PET/CT imaging prior to initiation of immunotherapy to identify PSMA PET/CT positive patients (estimated N=20) for long term follow up.  

In adult patients with advanced, pathologically confirmed HCC who are not amenable to curative restriction, transplantation or ablative therapies, and have radiographically measurable disease by RECIST; eligible for atezolizumab/bevacizumab front line therapy.

• Specific Aim 1.  To test the performance of novel biomarkers derived from PSMA PET/CT to measure response compared to RECIST criteria, in advanced HCC patients treated with immunotherapy. 
• Specific Aim 2. To identify precision ...

This study aims to investigate the utility of using plasma DNA methylation to detect measurable residual disease or early recurrence/progression of patients with hepatocellular carcinoma.

The purpose of this study is to create a registry of patients with liver cancer (also known as hepatocellular carcinoma) and individuals with no history of liver cancer in order to characterize risk factors for liver cancer and identify biomarkers for early detection of liver cancer. 

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 objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.

The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.

To determine the tumor radiotracer uptake of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ HCC by PET/CT. 

The purpose of this study is to assess community needs and attitudes toward participating in hepatobiliary cancer research for relevant, translatable, and sustainable research partnership.

This study will collect and store samples of tissue and blood for current and future research studies on Liver and Biliary Tumors.

The purpose of this study is to see if certain pre-transplant markers are able to predict how the kidney will respond after a liver transplant.

The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer.

TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...

This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in subjects with unresectable hepatocellular carcinoma.

The purpose of this study is to assess the effectiveness and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for advanced HCC. The patients cannot be eligible for locoregional therapy.

The purpose of this study is to compare the use of the Glycotest HCC Panel vs. the serum protein biomarker alpha-fetoprotein (AFP) for the early detection of Hepatocellular Carcinoma (HCC).

The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.

The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.

To determine the tumor radiotracer uptake of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ HCC by PET/CT. 

The purpose of this study is to find the rate of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma in individual populations of African descendants living in Minnesota, and to see what the current knowledge, attitudes and practices of these immigrants are towards screening, vaccination, and disease management.

This is a Phase II efficacy study of single agent ABC294640. Patients with advanced hepatocellular carcinoma (HCC) who have experienced tumor progression with 1st line single agent sorafenib will receive ABC294640 500 mg po bid continuously. Patients will continue on therapy until the development of progressive disease per modified RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).

The purpose of this study is to determine how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine 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. Giving combination chemotherapy after surgery may kill more tumor cells.

The primary purpose of this study is to assess the accuracy of the Philips High Precision 3D Ablation Solution software on cross-sectional imaging evaluation of microwave-ablated liver tumors, and to determine whether software accuracy varies based on patient, tumor, and technical procedural factors.

The purpose of this study is to facilitate discovery and development of novel biomarkers of risk and early detection, etiologic factors relating to liver disease, and novel targeted therapeutic and chemopreventive strategies for liver disease such as PSC, PBC, PLD, NAFLD, NASH, ASH, HCC, donors (non-diseased and diseased) for liver transplant or non-liver diseased subjects scheduled for surgery will serve as controls.

The goals of this study are to establish the role of circulating nucleic acid based biomarkers in early diagnosis, prognosis or treatment response in human diseases. These studies will determine whether alterations in circulating nucleic acids can distinguish between healthy and cancer tissue. 

The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer. The safety of this drug combination will also be studied.

The purpose of this study is to establish at least 200 patient-derived cancer xenografts (PDXs), and to utilize these PDXs in preclinical testing of single agents and drug combinations to guide precision cancer medicine decision-making with a focus upon the predominant racial/ethnic minority populations residing in California.

The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).

The primary purpose of the pilot study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).

The primary purpose of the phase II study is to estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data.

The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.

The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).

The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.

The purpose of this study is to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

This study is being done to:

1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.

2. A second purpose of this study is to obtain blood and tissue samples from participants ...

This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608 in combination with sorafenib, or BBI503 in combination with sorafenib. The study population is adult patients with advanced hepatocellular carcinoma who have not received systemic chemotherapy.

The main objective of this study is to identify minimally invasive, blood-based methylomic markers by comparing blood cfDNA methylation patterns among HIV-infected and uninfected HCC patients, and in HIV-infected but HCC-free patients. 
 

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.  

The purpose of this study is to demonstrate 1) feasibility of digital biomarker assessment using wearable in children with solid tumors who undergo surgery and 2) alterations in circulating proteins and metabolites indicative of a stressed state will persist postoperatively and correlate with clinical signs of recovery.

This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life ...

The purpose of this study is to create a biospecimen repository for both fresh frozen tissue from core needle biopsies and tumor resections as well as serial plasma collection.

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 evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.

The purpose of this study is to assess the ability to successfully create numerous validated patient-derived xenograft (PDX) models from patient tumor specimens obtained at surgery/biopsy via the new Pathology/TRAG cryopreservation protocol, and to generate a large catalog and repertoire of previously unavailable histologically validated PDX.

The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).

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.

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 purpose of this is to evaluate the safety, effectivess, pharmacokinetics, and pharmacodynamics of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or ...

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 assess the safety and tolerability of ADI-PEG 20 combined with pemetrexed and cisplatin in patients with tumors requiring arginine such as advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma (for dose escalation cohort only), non squamous non-small cell lung cancer (stage IIIB/IV), metastatic uveal melanoma, advanced liver cell cancer or recurrent high-grade glioma.

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells. PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in ...

The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancer types are: Non-Small Cell Lung Cancer (NSCLC) and melanoma that are progressing on checkpoint inhibitor (CPI, generally refers to anti-PD(L)1 antibodies) treatment, CPI-naïve hepatocellular carcinoma (HCC), and treatment-naïve endometrioid endometrial cancer.

The purpose of this study is to&nbsp;assess standardized benchmarks of intervention feasibility and acceptability for remotely delivered, group ACT-HBC, as tested with a single-arm pilot study.&nbsp;Determine if there are changes in psychological variables from baseline to completion of the ACT-HBC intervention.&nbsp;To explore the preliminary impact of rural status on feasibility and acceptability of the intervention in addition to outcomes of distress and theory-based statistical mediators/psychological mechanisms of ACT-HBC.

The primary purpose of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

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.

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

This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, 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 substances to them.

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.

The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).

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.

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 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 rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes ...

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 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.

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 collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.

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.

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

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.