21136 - Multi-indication study of regorafenib plus nivolumab

• Research type

  Research Study

• Full 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

• IRAS ID

  289706

• Contact name

  Uta Drews

• Contact email

  uta.drews@bayer.com

• Sponsor organisation

  Bayer AG

• Eudract number

  2020-003359-13

• Duration of Study in the UK

  3 years, 9 months, 21 days

• Research summary

  Summary of Research

  Researchers are looking for a better way to treat people with solid tumours. 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 tumours. These include tumours in the head and neck, the oesophagus, 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 receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120mg or down to 60mg by the doctor based on how well a participant tolerates treatment.
  The participants will take treatments in 4 week periods called cycles. In each cycle, the participants will receive nivolumab once. They will take regorafenib once a day for 3 weeks, then stop for 1 week. 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’ tumours 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.

  Summary of Results

  21136 Clinical Study Results in Plain Language with diagrams & images on -
  (Main/InterimResults) https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F21136%2FNBTI%2FYHO8AQ%2FAQ%2F19d47e33-b2a9-46a5-97b4-6246fa85e7d1%2F1%2F0nzBtQhj1a&data=05%7C02%7Cnewcastlenorthtyneside1.rec%40hra.nhs.uk%7Cde93fedb62e44317fcf608dd7364f644%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638793599649144789%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=xJJOGQ%2BUtSoWOnH4pnzyndDGzCDACEzo6PDOL3MGstI%3D&reserved=0

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  20/NE/0263

• Date of REC Opinion

  14 Dec 2020

• REC opinion

  Further Information Favourable Opinion