Nivolumab [NIV7]

Nivolumab for the adjuvant treatment newly diagnosed and completely resected stage III or completely resected stage IV malignant melanoma where the following criteria are met:

This application is made by and the first cycle of systemic anti-cancer therapy with nivolumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies and hepatitis.
This patient has a confirmed histological diagnosis of malignant melanoma. Please indicate whether the melanoma is BRAF V600 mutation positive or not:

The patient has melanoma which has been staged according to the AJCC 8th edition as stage III disease or completely resected stage IV disease. Please state which stage disease the patient has:

If stage III melanoma, the disease has been completely resected via sentinel node biopsy (‘sentinel lymphadenectomy’) or when indicated via completion lymph node dissection and/or there has been complete resection of intransit metastases; if stage IV melanoma, the distant metastatic disease has been completely resected of
The patient is treatment naïve to systemic therapy for malignant melanoma and in particular has not previously received any BRAF V600 inhibitors or MEK inhibitors
The patient is treatment naïve to systemic therapy for malignant melanoma and in particular has not previously received immunotherapy with any check point inhibitors unless this has been within the BMS adjuvant nivolumab access scheme in melanoma. Please tick correct box as to whether adjuvant nivolumab received via this scheme or not:

No previous adjuvant check point inhibitor immunotherapy or
Previous adjuvant nivolumab but only within BMS adjuvant nivolumab access scheme

The prescribing clinician has discussed with the patient the benefits and toxicities of adjuvant nivolumab in stage III or completely resected stage IV disease and if stage III disease, has used the expected median figures below in relation to the risk of disease relapse if a routine surveillance policy is followed:

for stage IIIA disease, the 5 and 10 year melanoma-specific survival probabilities with routine surveillance are 93% and 88%, respectively
for stage IIIB disease, the 5 and 10 year figures are 83% and 77%, respectively
for stage IIIC disease, the 5 and 10 year figures are 69% and 60%, respectively
for stage IIID disease, the 5 and 10 year figures are 32% and 24%, respectively

The patient has an ECOG performance status of either 0 or 1
Treatment with nivolumab will be continued for a maximum of 12 months (i.e. a maximum of 26 cycles if given every 2 weeks, or maximum of 13 cycles if given every 4 weeks) from the start of treatment in the absence of disease recurrence, unacceptable toxicity or withdrawal of patient consent
I confirm that a formal medical review to assess tolerability and whether treatment with nivolumab should continue or not will be scheduled to occur at least by the end of the first 4 cycles of treatment
Treatment breaks of up to 12 weeks beyond the expected cycle length are allowed but solely to allow any immune toxicities to settle
Nivolumab is to be otherwise used as set out in its Summary of Product Characteristics

NHS funded From: 15 June 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA684 (17 March 2021)

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