Nivolumab [NIV1]

Nivolumab for previously treated advanced renal cell carcinoma

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.
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-1 or anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
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:

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:

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: ________

The patient’s Karnofsky performance status (KPS) is 70 or more.
The patient will receive the licensed dose and frequency of nivolumab (i.e. either 240mg every 2 weeks or 480mg every 4 weeks).
The patient is to be treated until loss of clinical benefit or excessive toxicity or withdrawal of patient consent, whichever is the sooner.
A formal medical review to assess the tolerability of treatment with nivolumab will be scheduled to occur at least by the start of the 3rd 4-weekly cycle of treatment and thereafter on a regular basis.
When a treatment break of more than 3 months beyond the expected 2- or 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of Covid-19.
Nivolumab will otherwise be prescribed and administered as outlined in its Summary of Product Characteristics (SPC).

NHS funded From: 23 December 2016

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA417 (23 November 2016)

Important

This is an older version of the form. To view the most up to date form follow this link

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