Spots Global Cancer Trial Database for A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
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Trial Identification
Brief Title: A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
Official Title: A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors
Study ID: NCT04704154
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Rocky Mountain Cancer Centers / Aurora, CO, Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer Center at Dallas, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Hôpital Erasme/Erasmus Ziekenhuis, Brussels, , Belgium
UZ Antwerpen, Edegem, , Belgium
CHU de Liège, Liege, , Belgium
Institut Bergonié - Unicancer Nouvelle Aquitaine, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Hôpital de la Pitié-Salpétrière, Paris, , France
Institut de Cancérologie de l'Ouest - Saint Herblain, Saint-Herblain, , France
Institut Claudius Regaud - iUCT Oncopole, Toulouse Cedex 9, , France
Institut Gustave Roussy - Département de Médecine Oncologique, Villejuif Cedex, , France
AUSL di Bologna, Bologna, Emilia-Romagna, Italy
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A., Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
Istituto Oncologico Veneto IRCCS (IOV), Padova, Veneto, Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Saitama Cancer Center, Kita-Adachigun, Saitama, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
China Medical University Hospital, Taichung, , Taiwan
Chi-Mei Medical Center, Liouyine, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Royal Marsden NHS Trust (Surrey), Sutton, Surrey, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust, Coventry, West Midlands, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Royal Marsden Hospital (London), London, , United Kingdom
Contact Details
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