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 1-23 of 23
  • 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: 29 locations

  • 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 (metastatic), and / or cannot be removed by surgery (unresectable), 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: 16 locations

  • Regorafenib, with Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

    This phase II trial investigates how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, 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. The purpose of this research study is to compare the effects, good and / or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
    Location: 15 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). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org / news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
    Location: 11 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

  • A Study of Nivolumab Combined with FOLFOX and Regorafenib in Patients Who Have HER2-Negative Metastatic Esophagogastric Cancer

    This phase II trial studies the effect of nivolumab, combination chemotherapy, and regorafenib in treating patients with HER2-negative esophagus or stomach (esophagogastric) cancer that has spread beyond its original location to other parts of the body (metastatic). Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm. Nivolumab blocks the protein PD-1 (programmed cell death receptor-1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them. Regorafenib is a type of drug called a tyrosine kinase inhibitor (TKI). This drug targets the tyrosine kinase protein found in or on the surface of cancer cells that the cells need to survive and grow. Blocking this protein may stop cancer cells from growing, or cause them to grow more slowly or to shrink. FOLFOX is a combination of three standard chemotherapy drugs (leucovorin, 5-fluorouracil, and oxaliplatin) that work by damaging the DNA in cancer cells, which can cause the cells to stop growing and die. Giving nivolumab and regorafenib together with combination chemotherapy may work better than combination chemotherapy alone in treating patients with esophagus or stomach cancer.
    Location: 7 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: 8 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: 7 locations

  • An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

    The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
    Location: 5 locations

  • Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1 / PD-L1 Immune Checkpoint Inhibitors

    Researchers are looking for a better way to treat people suffering from liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab. There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1 / PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC. During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.
    Location: 4 locations

  • 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: 4 locations

  • A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer

    A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)
    Location: 3 locations

  • 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 thyroid cancer that does not respond to radioiodine therapy (radioiodine refractory). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

    Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts. The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years. During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer

    This phase I trial studies the side effects and best dose of regorafenib when given together with ipilimumab and nivolumab in treating patients with microsatellite stable colorectal cancer that has spread to other places in the body (metastatic) and remains despite chemotherapy treatment (resistant). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and 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, ipilimumab and nivolumab may slow the tumor growth and / or shrink the tumor size in patients with colorectal cancer.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Amplitude-Modulated Electromagnetic Fields and Regorafenib as Second-Line Therapy for the Treatment of Patients with Advanced Hepatocellular Carcinoma

    This phase II trial studies the effects of amplitude-modulated electromagnetic fields and regorafenib as second-line therapy for the treatment of patients with hepatocellular carcinoma that has spread to other places in the body (advanced), and who have received any first line systemic therapy, either standard of care sorafenib or lenvatinib, or any experimental therapy. Amplitude-modulated electromagnetic fields may interfere with the growth of tumor cells by directing radio waves at the tumor. Regorafenib interferes with the growth of tumor cells. Giving amplitude-modulated electromagnetic fields and regorafenib may kill more cancer cells.
    Location: Wake Forest University Health Sciences, Winston-Salem, North Carolina

  • 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

  • Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

    This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • 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 (recurrent) or spread to other places (metastatic). Regorafenib and 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

  • An Open Label Study Evaluating the Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer.

    This randomized phase 1b / 2 open-label study will evaluate the efficacy of etrumadenant (AB928) treatment combinations in patients with metastatic colorectal cancer.
    Location: 2 locations

  • Optimization for Regorafenib in HCC

    This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • 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: See Clinical Trials.gov

  • Regorafenib and Durvalumab for the treatment of Unresectable or Metastatic Biliary Tract Cancer

    This phase I / II trial studies the best dose of regorafenib given together with durvalumab and the effect of regorafenib and durvalumab in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and durvalumab may help control cancer growth in patients with biliary tract cancer.
    Location: University of Kansas Cancer Center, Kansas City, Kansas