CA045-001 Nivolumab and NKTR-214 in patients with advanced melanoma
Research type
Research Study
Full title
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
IRAS ID
250087
Contact name
James Larkin
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-001423-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 7 months, 0 days
Research summary
This is a multicentre, phase 3 study of the study drug called Nivolumab, given alone or with another study drug called NKTR-214 in patients, 12 years old and above, with previously untreated metastatic, or unresectable melanoma.
Nivolumab and NKTR-214 are types of immunotherapy drugs that stimulate the body’s own immune system to attack cancer cells.
This study will assess if NKTR-214 given with Nivolumab delays the progression of previously untreated metastatic, or unresectable melanoma for longer than Nivolumab alone.
764 patients will take part globally in this study, with 54 of them in the UK.
After a screening period, patients will have a treatment period and a follow-up period. During the treatment period, patients will randomly receive Nivolumab alone or Nivolumab and NKTR-214, every 3 weeks.
Patients will receive the drugs into a vein. Both the patients and the study doctor will know which treatment patients will receive.
NKTR-214 can drop the blood pressure. To prevent this, patients who receive the NKTR-214 study drug, might receive salty water in a vein before their treatment. For the few days following NKTR-214 treatments, patients should also drink at least 2 litres of liquid every day and refrain from doing anything that makes them sweat, such as energetic exercise or go to the sauna. Patients will also have an examination of their heart to ensure that they can take part in the study.
During their study participation, patients will have physical examinations (including vital signs, temperature and weight), scans, up to 4 biopsies, questionnaires, blood samples for safety and for study-specific tests. Patients will receive the drugs for up to 2 years ,or until they withdraw their consent to their study treatment; they no longer tolerate the study treatment; or their cancer progresses.
The study is paid by Bristol-Myers Squibb (BMS).Summary of study results:
Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).
URL to summary results:
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03635983%253Fcond%253DMetastatic%252520melanoma%2526term%253DCA045-001%2526rank%253D1%2526tab%253Dresults%2523study-record-dates%2FNBTI%2FfK63AQ%2FAQ%2Fc92ce60b-7fe4-45fe-bf23-f4a92f386a92%2F3%2FFiUqeDEZFO%23study-record-dates&data=05%7C02%7Capprovals%40hra.nhs.uk%7C027281a1258242b553d808dcc8d69053%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638606071077354309%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=yJkGNJzdLFoiE7vnCDXlBctl7MLQCL6Z%2BEKiDYn7mOU%3D&reserved=0
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0356
Date of REC Opinion
19 Dec 2018
REC opinion
Further Information Favourable Opinion