Published

May 23, 2025

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:

  1. 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
  2. This patient has a confirmed histological diagnosis of malignant melanoma. Please indicate whether the melanoma is BRAF V600 mutation positive or not:
  • BRAF V600 mutation positive or
  • BRAF V600 mutation negative
  1. 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:
  • Stage IIIA disease or
  • Stage IIIB disease or
  • Stage IIIC disease or
  • Stage IIID disease or
  • Stage IV disease that has been completely resected
  1. 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
  2. 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 or immunotherapy with any check point inhibitors.
  3. 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
  1. The patient has an ECOG performance status of either 0 or 1
  2. Treatment with nivolumab will be continued for a maximum of 12 months (or a maximum of 26 cycles if given 2-weekly) or 13 administrations (when administered every 4 weeks) from the start of treatment in the absence of disease recurrence, unacceptable toxicity or withdrawal of patient consent.
  3. The patient will receive the licensed dose, frequency, and route of nivolumab for this indication, as shown below • Subcutaneously – at a dose of 600mg every 2 weeks, or 1200mg every 4 weeks • Intravenously – at a dose of 240mg every 2 weeks, or 480mg every 4 weeks
  4. When a treatment break of more than 12 weeks beyond the expected 2- or 4-weekly cycle length is needed, I will complete a treatment break approval form requesting a restart of treatment. This must be approved before nivolumab is re-commenced
  5. Nivolumab is to be otherwise used as set out in its Summary of Product Characteristics

NHS funded From: 15 June 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA684 (17 March 2021)

Current Form Version

Note

The data on this page was produced using version 1.364 of the CDF list, downloaded from NHS England’s website on 23 May 2025 at 18:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.