Targeted drug therapy

Displaying 94 studies

  • Treatment of IgG4-Related Disease With Revlimid and Rituximab Rochester, MN

    Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?

  • MEmbranous Nephropathy Trial Of Rituximab Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is more effective than Cyclosporine in inducing long term remission of proteinuria.

  • Rituximab in the Treatment of Idiopathic Membranous Nephropathy Rochester, MN

    Membranous glomerulopathy (MN) is still the most common glomerular disease associated with nephrotic proteinuria (NS). Up to 40% of patients reach end stage renal failure (ESRD), making MN the 2nd or 3rd most common cause of ESRD caused by a primary glomerulopathy. Current treatment options include corticosteroids, alkylating agents, and cyclosporin, but their use is controversial and the associated adverse effects and high cost temper their usage. Experimental data in MN suggests that B cell activation results in immunoglobulin deposition along the glomerular basement membrane causing injury to the membrane and subsequent proteinuria. Drugs that non-selectively inhibit B cells and, ...

  • Bortezomib, Rituximab, and Dexamethasone with or without Temsirolimus in Treating Patients with Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma Rochester, MN

    This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth ...

  • A Study Of Binimetinib In Children And Adults With NF1 Plexiform Neurofibromas Rochester, MN

    The purpose of this study is to evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to binimetinib in children and adults with NF1 and inoperable plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease in tumor volume reduction by 12 courses.

  • A Study To Evaluate The Safety And Effectiveness Of Avapritinib In Patients With Indolent And Smoldering Systemic Mastocytosis Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The primary purpose of Part 1 of this study is to determine the Recommended Phase 2 Dose (RP2D) in patients with Indolent Systemic Mastocytosis (ISM) for use in Part 2 and Part 3 of the study.

    The primary purpose of Part 2 of this study is to determine the effect of avapritinib in reducing symptoms in Indolent Systemic Mastocytosis (ISM) and Smoldering Systemic Mastocytosis (SSM) patients, as compared to placebo.

    The primary purpose of Part 3 of this study is to assess the long-term safety and effectiveness of avapritinib in Indolent Systemic Mastocytosis (ISM) and Smoldering Systemic Mastocytosis (SSM) patients.

  • Rituximab In Progressive IgA Nephropathy Rochester, MN

    Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy. Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury, we speculate that the reduction of circulating IgA may reduce proteinuria and injury in patients with IgA nephropathy. Moreover, the absence of prospective trials in the treatment of IgA disease and the lack of consensus for long-term treatment, the superior side-effect profile of this form of therapy may lead ...

  • Study Of Targeted Therapies For The Treatment Of Adult Participants With Moderate To Severe Crohn's Disease Rochester, MN

    Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. ...

  • A Study of Outcomes with Rituximab Induction versus Maintenance Treatments for IgG4-Related Diseases Rochester, MN

    The purpose of this study is to compare IgG4-related disease remission and relapse rates between patients who had induction rituximab treatment with or without follow-up maintenance rituximab therapy, at Mayo Clinic, Rochester between 1 January 2000 and 22 December 2015.

  • A Study To Investigate The Efficacy And Safety Of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib In Adults With Relapsed/Refractory Mantle Cell Lymphoma Scottsdale/Phoenix, AZ; Rochester, MN

    The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

  • A Study Of An FGFR2/3 Inhibitor (CGT4859) In Patients With Cholangiocarcinoma And Other Advanced Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.

  • A Study Of Bendamustine And Rituximab Alone Versus In Combination With Acalabrutinib In Subjects With Previously Untreated Mantle Cell Lymphoma Scottsdale/Phoenix, AZ; Rochester, MN

    This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

  • E6201 Plus Dabrafenib For The Treatment Of Metastatic Melanoma Central Nervous System Metastases (CNS) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.

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  • First In Human Study Of TORL-1-23 In Participants With Advanced Cancer Rochester, MN

    This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

  • A Study To Evaluate Larotrectinib To Treat Patients With Previously Untreated TRK Fusion Solid Tumors And TRK Fusion Relapsed Acute Leukemia Rochester, MN

    The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

  • A Study In Subjects With Relapsed And Refractory Multiple Myeloma Receiving Carfilzomib In Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW) Scottsdale/Phoenix, AZ

    The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

  • A Study To Learn About The Study Medicine (Elranatamab) In Participants With Multiple Myeloma That Has Come Back After Responding To Treatment Or Has Not Responded To Treatment Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic.  After the initial step-up doses, participants will start receiving one dose every ...

  • Ibrutinib In Treating Patients With Relapsed Hairy Cell Leukemia Rochester, MN

    This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

  • A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.

  • informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia Jacksonville, FL

    The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).

  • A Study To Evaluate CB-839 HCl In Combination With Carfilzomib And Dexamethasone In Treating Patients With Recurrent Or Refractory Multiple Myeloma Rochester, MN

    The purpose of this study is to determine the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone 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 CB-839 HCl, carfilzomib, and dexamethasone may work ...

  • A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).

  • A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.

  • A Clinical Study Of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) In People With Breast Cancer (MK-2870-032) Scottsdale/Phoenix, AZ; Jacksonville, FL

    Researchers are looking for new ways to treat types of breast cancer that are both:

    * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
    * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

    Sacituzumab ...

  • Open-label Trial of Daratumumab in Treatment of PGNIMD and C3 GN Rochester, MN

    This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease in the kidney due to the production of abnormal proteins. There are no known standard effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy. These diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal ...

  • A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.

  • Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2 Rochester, MN

    The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.

  • Alisertib With Or Without Fulvestrant In Treating Patients With Locally Advanced Or Metastatic, Endocrine-Resistant Breast Cancer Rochester, MN

    This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.

  • Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma No Locations

    RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.

    PURPOSE: ...

  • Ibrutinib And Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, And Rituximab In Treating Patients With Untreated Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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. Monoclonal antibodies, such as rituximab, interfere with the ability of cancer ...

  • Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.

    PURPOSE: ...

  • Cabozantinib-S-Malate In Treating Younger Patients With Recurrent, Refractory, Or Newly Diagnosed Sarcomas, Wilms Tumor, Or Other Rare Tumors Rochester, MN

    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.

  • A Study Of Tucatinib With Trastuzumab And MFOLFOX6 Versus Standard Of Care Treatment In First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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). 

  • A Study To Compare Linvoseltamab And Daratumumab Treatment In High-Risk Smoldering Multiple Myeloma (HR-SMM) Scottsdale/Phoenix, AZ; Rochester, MN

    This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.

    The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.

    The study is looking at several other research questions, including:

    * What side effects may happen from taking the study drug
    * How much study drug is in the blood at different times
    * Whether the body makes antibodies against the study drug (which could make ...

  • Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Jacksonville, FL; Rochester, MN

    This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 ...

  • Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme Rochester, MN

    RATIONALE: Dasatinib 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 block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. ...

  • Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients with Refractory or Relapsed Indolent Non-Hodgkin Lymphoma Rochester, MN

    RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells.

    PURPOSE: This phase I trial studies the side effects and ...

  • Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye Rochester, MN

    This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

  • A Study To Compare ACP-196 And Obinutuzumab With Chlorambucil, Or ACP-19 Alone, With Obinutuzumab And Chlorambucil, For Patients With Previously Untreated Chronic Lymphocytic Leukemia Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the effectiveness of  ACP-196  combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

  • Ramucirumab And Paclitaxel Or FOLFIRI In Advanced Small Bowel Cancers Rochester, MN

    This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop ...

  • Study Comparing CB-839 With Cabozantinib Vs. Cabozantinib With Placebo In Patients With Metastatic Renal Cell Carcinoma Scottsdale/Phoenix, AZ

    This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.

  • Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia Scottsdale/Phoenix, AZ; Rochester, MN

    In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people

  • Study of RP-6306 With FOLFIRI in Advanced Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    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.

  • Testing The Addition Of A New Drug, Venetoclax, To The Usual Treatment (Ibrutinib And Rituximab) For Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ...

  • A Study To Evaluate Acalabrutinib With Or Without Obinutuzumab To Treat Early-Stage Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Patients Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

  • Testing The Addition Of Abemaciclib To Olaparib For Women With Recurrent Ovarian Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...

  • A Study To Evaluate Brentuximab Vedotin Or Placebo In Combination With Lenalidomide And Rituximab In Subjects With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Rochester, MN

    The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma  (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...

  • Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma Scottsdale/Phoenix, AZ; Rochester, MN

    This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.

  • Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer Rochester, MN

    This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.

  • Bortezomib Or Carfilzomib With Lenalidomide And Dexamethasone In Treating Patients With Newly Diagnosed Multiple Myeloma Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells

  • Study Of Daraxonrasib And Daraxonrasib + GnP As First-line Treatment In Patients With Metastatic Pancreatic Adenocarcinoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

  • Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma Rochester, MN

    Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.

    Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.

    GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity ...

  • Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination ...

  • Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

  • A Study To Assess The Efficacy, Safety, Pharmacodynamics, And Pharmacokinetics Of Tazemetostat In Combination With Lenalidomide Plus Rituximab Versus Placebo In Combination With Lenalidomide Plus Rituximab In Adult Patients At Least 18 Years Of Age With Relapsed/Refractory Follicular Lymphoma. Jacksonville, FL; Rochester, MN

    The participants of this study would have relapsed/refractory follicular lymphoma.

    Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.

    Stage 1 of this trial studied the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.

    Stages 2 and 3 were ...

  • A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma Rochester, MN

    Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).

    Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...

  • Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations Rochester, MN

    This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib 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. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.

  • Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma Scottsdale/Phoenix, AZ; Rochester, MN

    RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.

    PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...

  • DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.

  • REFINE: Regorafenib Observational Study In Hepatocellular Carcinoma Rochester, MN

    The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.

  • A Study Evaluating The Efficacy Of Venetoclax Plus Ibrutinib In Subjects With T-cell Prolymphocytic Leukemia Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:

    Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.

    Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.

  • Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP In Newly Diagnosed High-intermediate And High Risk DLBCL Patients Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.

  • Targeted Therapy Directed By Genetic Testing In Treating Patients With Locally Advanced Or Advanced Solid Tumors, The ComboMATCH Registration Trial Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P

    atients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) ...

  • Lenalidomide And Dexamethasone With Or Without Bortezomib In Treating Patients With Previously Untreated Multiple Myeloma Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...

  • Testing The Addition Of Duvelisib Or CC-486 To The Usual Treatment For Peripheral T-Cell Lymphoma Rochester, MN

    The purpose of this study is to evaluate the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, 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. This trial may help find out if this approach is better or ...

  • Inotuzumab Ozogamicin In Treating Younger Patients With Relapsed Or Refractory CD22 Positive B Acute Lymphoblastic Leukemia Rochester, MN

    This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.

  • A Study Comparing Ibrutinib And Obinutuzumab With Or Without Venetoclax In Treating Patients With Chronic Lymphocytic Leukemia Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN

    The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...

  • A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...

  • Ixazomib Citrate, Lenalidomide, Dexamethasone, And Daratumumab In Treating Patients With Newly Diagnosed Multiple Myeloma Rochester, MN

    This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...

  • A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients Albert Lea, MN; Eau Claire, WI; Rochester, MN

    The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...

  • A Study Of Belantamab Mafodotin (GSK2857916) In Multiple Myeloma Participants With Normal And Impaired Renal Function Jacksonville, FL

    The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.

    Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.

     

  • A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma Jacksonville, FL

    The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).

  • A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma Eau Claire, WI; Rochester, MN

    The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...

  • Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy Rochester, MN

    This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...

  • A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).

     

  • Study Of 225Ac-ABD147 To Establish Optimal Dose In Patients With SCLC And LCNEC Of The Lung That Previously Received Platinum-based Chemotherapy Jacksonville, FL; Rochester, MN

    The study has 2 parts, Phase 1a and Phase 1b. The goal of Phase 1a is to gather safety, PK and initial efficacy data for 225Ac-ABD147 to better understand best doses for patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung following platinum-based chemotherapy.

    An initial group of patients will also be given an experimental imaging agent called 111In-ABD147 to help understand where ABD147 goes in the body.

    The goal of Phase 1b is to gather additional safety and efficacy data on 225Ac-ABD147 to determine the best dose and to understand how those doses affect ...

  • A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.

  • Atezolizumab In Combination With A Multi-Kinase Inhibitor For The Treatment Of Unresectable, Locally Advanced, Or Metastatic Liver Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    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. ...

  • A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia Rochester, MN

    This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.

  • Safety And Activity Of PolyPEPI1018 Plus Atezolizumab In Colorectal Cancer. Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

  • A Study To Evaluate Daratumumab And Ibrutinib To Treat Relapsed / Refractory Chronic Lymphocytic Leukemia Treatment (DIRECT) Jacksonville, FL

    For cohort 1: The primary goal is to the determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on/or are previously treated with ibrutinib.
    For Cohort 2: The primary goal is to determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment.

    Secondary Goals:
    For Cohort 1
    -Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy.
    -The overall incidence of MRD (minimal ...

  • Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant Rochester, MN

    This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.

  • A Study Comparing CAR-T Therapy Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) Or Daratumumab, Pomalidomide And Dexamethasone (DPd) In Participants With Relapsed And Lenalidomide-Refractory Multiple Myeloma Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

  • A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer Rochester, MN

    This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.

  • Study Of Endocrine Therapy With Or Without Abemaciclib (LY2835219) Following Surgery In Participants With Breast Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

  • A Study Of Tucatinib Or Placebo With Trastuzumab And Pertuzumab For Metastatic HER2+ Breast Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. 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 will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body ...

  • A Study To Evaluate Daratumumab/rHuPh20 +/- Lenalidomide As Post-ASCT Maintenance For Multiple Myeloma With Minimal Residual Disease (MRD) To Direct Therapy Duration Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN

    The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.

  • First In Human (FIH) Study Of REGN5459 In Patients With Relapsed Or Refractory Multiple Myeloma (MM) Rochester, MN

    The purpose of this study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit. 

  • Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

  • Aggressive Smoldering Curative Approach Evaluating Novel Therapies And Transplant Rochester, MN

    This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.

  • Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer Rochester, MN; Jacksonville, FL

    This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.

  • Rituximab With Or Without Stem Cell Transplant In Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma In First Complete Remission Jacksonville, FL; Rochester, MN

    This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. ...

  • A Study To Evaluate Abemaciclib For Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.

  • A Study To Determine The Effects Of COVID-19 In Cancer Patients Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN

    The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

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