Published

May 16, 2025

Nivolumab [NIV1]

Nivolumab for previously treated advanced renal cell carcinoma

  1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has unresectable locally advanced or metastatic renal cell carcinoma (RCC) which has either a clear cell component or is one of the types of RCC as indicated below. Please indicate below which RCC histology applies to this patient:
  • RCC with a clear cell component or
  • Papillary RCC or
  • Chromophobe RCC or
  • Collecting duct RCC (Bellini collecting duct RCC) or
  • Medullary RCC or
  • Mucinous tubular and spindle cell RCC or
  • Multilocular cystic RCC or
  • XP11 translocation RCC or
  • Unclassified RCC
  1. The patient has been previously treated with only 1 or 2 previous lines of antiangiogenic therapy for advanced or metastatic disease. Please indicate below the number of prior lines of antiangiogenic therapy with which the patient has been treated:
  • 1 prior line
  • 2 prior lines
  1. The patient is either completely treatment naïve for immune-modulatory therapies (anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD L2, anti-CD137 or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibodies) of any kind for RCC or if the patient has received prior immune-modulatory therapies in the context of adjuvant/neoadjuvant therapy, then such treatment was completed 12 or more months prior to the first relapse and the patient meets all other criteria listed here. Please mark below whether or not previous systemic immune-modulatory therapy for RCC has ever been received in the adjuvant/neoadjuvant/advanced disease setting:
  • no previous therapy with immune-modulatory therapies (anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD L2, anti-CD137 or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA- 4) antibodies) of any kind or
  • prior adjuvant/neoadjuvant therapy with immune-modulatory therapies for RCC (anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD L2, anti-CD137 or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibodies) and last dose received by the patient was 12 or more months prior to first relapse Please mark in the box the time between the end of treatment with adjuvant/neoadjuvant immune-modulatory therapy and first relapse: ________
  1. The patient’s Karnofsky performance status (KPS) is 70 or more.
  2. 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
  3. The patient is to be treated until loss of clinical benefit or excessive toxicity or withdrawal of patient consent, whichever is the sooner.
  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 will otherwise be prescribed and administered as outlined in its Summary of Product Characteristics (SPC).

NHS funded From: 23 December 2016

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA417 (23 November 2016)

Current Form Version

Note

The data on this page was produced using version 1.363 of the CDF list, downloaded from an archive of NHS England’s website on 16 May 2025 at 14:00.

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.

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