Bempegaldesleukin+Nivolumab vs Nivolumab ph3 resected melanoma study
Research type
Research Study
Full title
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
IRAS ID
1003344
Contact name
Toby Talbot
Contact email
Eudract number
2020-000917-34
Research summary
Melanoma is the most serious form of skin cancer. Resected localised melanomas and
regionally advanced melanomas with lymph node involvement are at a high risk of
recurrence. Recurrence is associated with poor survival outcomes. In large global
adjuvant studies of resected melanoma patients, improvements in the recurrence-free
survival rates were noted. Therefore, developments in adjuvant therapy have the
potential to reduce/ delay recurrence and extend survival in resected melanoma patients.
The study treatments are bempegaldesleukin (NKTR-214) and nivolumab.
Bempegaldesleukin has not been approved by any regulatory authority. Nivolumab is
approved for use to treat a variety of cancer types, including melanoma, in 60 countries
including the US and UK.
Bempegaldesleukin is a modified form of a protein called interleukin-2 (IL-2), normally
made by the immune system which triggers other cells to start attacking cancer cells.
Nivolumab is an anti-PD-1 antibody which works by attaching to and blocking a
molecule called PD1. PD1 is present on different cells in the immune system, controlling
parts of it by shutting it down. Anti-PD-1 antibodies can potentially prevent the shutting
down of the immune system in certain cancers, allowing immune cells to recognise and
destroy cancer cells.
The study will evaluate the effectiveness, safety, and tolerability of bempegaldesleukin
when combined with nivolumab, in comparison to using nivolumab alone after complete
resection of melanoma in participants at high risk of recurrence.
This study has 2 arms. Arm A will receive bempegaldesleukin + nivolumab. Arm B will
receive just nivolumab.
During the study, the treatments will be given, and patients will undergo blood tests,
physical examinations, questionnaires, CT/MRI scans, ECG (electrocardiogram),
Ultrasound and echocardiogram/MUGA.
This study will recruit approximately 950 patients in 200 centres in North America,
Europe and Australia. Patients’ participation could be up to 5 years.REC name
HSC REC A
REC reference
20/NI/0100
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion