A Phase 1/2 of NKTR-214 and Nivolumab
Research type
Research Study
Full title
A Phase 1/2, open-label, multicentre, dose escalation and dose expansion study of NKTR-214 and Nivolumab in patients with select locally advanced or metastatic solid tumor malignancies
IRAS ID
227570
Contact name
Michael Imperiale
Contact email
Eudract number
2016-003543-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 17 days
Research summary
Aldesleukin (sometimes called interleukin-2 or IL2) is classified as a cytokine. Cytokines act primarily by communicating between the various cells of the body's immune system. It is used to treat kidney cancer that has spread to other parts of the body and a type of skin cancer called melanoma. It may also be used to treat other types of cancer as part of a clinical trial. Aldesleukin stimulates the immune system (your body’s natural defence against infection and disease) to fight some types of cancer. It encourages a type of white blood cell to recognise and destroy the cancer cells.
Unfortunately, Aldesleukin has several limitations such as in patient hospital administration, 5 days of consecutive dosing and potential for serious toxicities. Nektar Therapeutics have designed NKTR-214 for the purpose of outpatient therapy as well as alleviate the serious toxicity which can be activated with rapid immune activation seen with administration of high levels of interleukin-2.
There are 2 parts to this study. Part 1 is focused on dose escalation and took place in the US only. Part 2 is dose expansion and will take part in US and non-US countries. Approximately, 250 subjects will be enrolled on to Part 2 of this study and will receive NKTR-214 in combination with Nivolumab (another targeted therapy drug currently used to treat melanoma, non-small cell lung cancer or kidney (renal cell) cancer. It may also be used to treat other cancers as part of a clinical trial). Treatment with NKTR-214 will be given every 14 or 21 days. Each participant's NKTR-214 dose will be determined by the NKTR-214 dose escalation scheme and the participant's weight in kilograms. The end of the study is defined as no more than 3 years after the last patient received their first dose of NKTR-214 or Sponsors decision to terminate the study, whichever comes first. Survival data may be collected beyond the end of the study.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0182
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion