CABOPOINT
Research type
Research Study
Full title
A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS
IRAS ID
1003124
Contact name
Thomas Powles
Contact email
Eudract number
2018-002820-18
Research summary
Renal Cell Cancer (RCC) is a type of kidney cancer that starts in the lining of very small\ntubes in the kidney. Kidney cancer is one of the ten most common cancers worldwide.\nLike other cancers, RCC begins as a small growth and grows larger over time. The study\ndrug cabozantinib belongs to a drug class that targets specific proteins, called tyrosine\nkinases, that blocks the cancer growth and has shown significant effect in suppressing\ncancer activity.\nIpsen Pharma are sponsoring this Phase II research study to see if cabozantinib is\neffective as a second line treatment for RCC which has spread to other parts of the body,\ncannot be surgically removed, and has not responded adequately to first line treatments.\nAround 250 adult patients who have RCC after cancer progression with CPI treatment\n(Checkpoint Inhibitor Therapy - a type of drug that blocks certain proteins made by some\ntypes of immune system cells and some cancer cells) combined or not, with anti-VEGF\ntherapy (an anti-angiogenic drug, a drug class that targets and slows down the\ndevelopment of new blood vessels that are needed to supply nutrients to the cancer cells)\nwill be enrolled from about 50 study hospitals in 7 European countries. This research\nstudy will also evaluate/monitor whether the study drug is safe and tolerable for\nparticipants.\nCabozantinib is approved by both the European Medicines Agency (EMA) in the\nEuropean Union (EU), and the Food and Drug Administration (FDA) in the United\nStates (US), for treatment for adults with advanced RCC.\nAll participants will take a daily dose of cabozantinib 60mg until they are withdrawn/the\nstudy ends. This dose can be reduced or interrupted for management of AEs. This is an\nopen-label study which means both participants and the study doctor will know what\ndrug is being given. Participants who stop study treatment will be followed up every 12\nweeks for survival status and subsequent anti-cancer therapy information until they\nexpire or the study ends.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0192
Date of REC Opinion
9 Oct 2020
REC opinion
Further Information Favourable Opinion