Clinical Trials Using Regorafenib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Regorafenib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-18 of 18
  • (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

    This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
    Location: 13 locations

  • SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

    Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and / or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing / Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
    Location: 10 locations

  • TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

    The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).
    Location: 9 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

    A phase Ib / II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.
    Location: 8 locations

  • Regorafenib in Treating Patients with Previously Treated, Metastatic, or Locally Advanced Angiosarcoma

    This phase II trial studies regorafenib in treating patients with previously treated angiosarcoma that has spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

    This study will determine if the combination of regorafenib and pembrolizumab is safe and tolerated in patients with advanced liver cancer. In addition, the study will explore the anti-tumor activity of this combination as well as potentially identifying blood and tissue biomarkers associated with disease activity, status or response. The study will also investigate how the drugs behave in your body
    Location: 4 locations

  • A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

    Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II / III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
    Location: 6 locations

  • Regorafenib and Pembrolizumab in Treating Participants with Advanced or Metastatic Colorectal Cancer

    This phase I / II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, 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 pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.
    Location: 4 locations

  • Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

    The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells. Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Regorafenib for the Treatment of Bevacizumab Refractory Recurrent Glioblastoma

    This phase II trial studies how well regorafenib works in treating patients with glioblastoma that has come back (recurrent) and that does not respond to treatment (refractory) with bevacizumab. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients with Advanced or Metastatic Colorectal Cancer

    This phase II trial studies circulating cell-free tumor DNA testing to guide treatment with regorafenib or TAS-102 in patients with colorectal cancer that has spread to other areas of the body. Studying samples of blood from patients with colorectal cancer may help doctors understand how well patients respond to treatment. Regorafenib and TAS-102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well ctDNA testing works in guiding treatment with regorafenib and TAS-102 for patients with advanced or metastatic colorectal cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Regorafenib and Nivolumab in Treating Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer

    This phase I trial studies the side effects and best dose of regorafenib when given with nivolumab in treating patients with mismatch repair proficient colorectal cancer that has spread to other places in the body (advanced) and does not respond to treatment (refractory). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving regorafenib and nivolumab may work better in treating colorectal cancer.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Regorafenib, Hydroxychloroquine, and Entinostat in Treating Patients with Metastatic Colorectal Cancer

    This phase I / II trial studies the side effects and best dose of hydroxychloroquine and entinostat when given together with regorafenib, and to see how well they work in treating patients with colorectal cancer that has spread to other places in the body. Hydroxychloroquine may help decrease resistance to chemotherapy, entinostat may help to disrupt the signaling of cancer cells, and regorafenib may help to decrease the blood supply of a tumor. Giving hydroxychloroquine, entinostat, and regorafenib together may work better in treating patients with colorectal cancer.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Regorafenib in Treating Patients with Relapsed or Refractory, Advanced Myeloid Malignancies

    This phase I trial studies the side effects and best dose of regorafenib in treating patients with myeloid malignancies that have spread to other places in the body and have come back or do not respond to treatment. Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

    The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated. This study will also provide another mechanism for reporting adverse events related to study drug safety.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Panitumumab, Regorafenib, or TAS-102, in Treating Patients with Metastatic and / or Unresectable RAS Wild-Type Colorectal Cancer

    This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body, and / or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
    Location: 6 locations

  • Regorafenib and Methotrexate in Treating Participants with Recurrent or Metastatic Non-Small Cell Lung Cancer

    This phase II trial studies how well regorafenib works together with methotrexate in treating participants with non-small cell lung cancer that has come back or spread to other places. Drugs used in chemotherapy, such as regorafenib, 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. Methotrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving regorafenib and methotrexate may work better in treating participants with non-small cell lung cancer.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Regorafenib in Treating Patients with Metastatic Medullary and Differentiated Radioiodine Refractory Thyroid Cancer

    This phase II trial studies how well regorafenib works in treating patients with medullary thyroid cancer that has spread to other places in the body (metastatic), and differentiated radioiodine thyroid cancer that does not respond to treatment (refractory). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: See Clinical Trials.gov