Published

May 11, 2025

Nivolumab [NIV8a]

Nivolumab monotherapy (with or without initial combination treatment with ipilimumab) for treating unresectable advanced malignant melanoma (form a): REGISTRATION OF START OF NIVOLUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY (WITHOUT INITIAL COMBINATION WITH IPILIMUMAB) OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY AFTER INITIAL COMBINATION WITH IPILIMUMAB (clinicians starting patients on nivolumab plus ipilimumab combination treatment should only use this form after the ipilimumab part of the treatment has been completed). This form comes in 3 parts 1. The first part is for patients who are either scheduled to commence nivolumab monotherapy or who commenced and continue to receive nivolumab monotherapy or who continue to receive nivolumab monotherapy after initial combination treatment with ipilimumab. The second part of the form which must use the same unique Blueteq identifier for those benefitting patients who choose to electively discontinue nivolumab after or more years of treatment. 2. The second part (patient details will automatically entered) will only appear once the first part of the form is approved and should be completed at the time of elective discontinuation of nivolumab. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped nivolumab and whom there is disease progression for which the clinician wishes to re- commence nivolumab monotherapy. 3. The third part of the form (patient details will be automatically entered) will only appear once the second part of the form has been approved.

  1. This application has been made by and the first cycle of systemic anti -cancer therapy with nivolumab will be/was prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy. Note: if treatment with nivolumab has already commenced, it is vital that the first treatment start date has been entered in the box above.
  2. 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. or
  3. The patient has a histologically- or cytologically-confirmed diagnosis of malignant melanoma.
  4. The patient has unresectable or advanced melanoma.
  5. In respect of his/her treatment for unresectable/advanced disease and at the time of starting nivolumab, the patient is/was treatment-naïve to systemic therapy or has/had previously only received BRAF/MEK-targeted therapy or ipilimumab monotherapy or both BRAF/MEK-targeted treatment and ipilimumab monotherapy.
  6. At the time of commencing nivolumab the patient has/had not received prior treatment with any of the following: anti-PD-1, anti-PD-L1, anti-PD-L2 and anti-CD137 treatments unless the patient has received adjuvant immunotherapy with nivolumab or pembrolizumab in which case the patient must have relapsed after the discontinuation of such adjuvant immunotherapy. Please tick appropriate box:
  • No prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CD137 treatments or
  • Prior adjuvant immunotherapy with nivolumab or pembrolizumab or
  • Nivolumab initially started in combination with ipilimumab (see question 9 below)
  1. There is the future opportunity for patients continuing in a stable disease or a response disease state after 2 or more years of planned treatment to choose to discontinue nivolumab and then to re-start nivolumab monotherapy on disease progression as the next systemic therapy and should this option be chosen that both the date of discontinuation must be registered on the second part of this form and the application to re-start nivolumab be made on the third part of this form. is 8. The patient has a sufficient performance status (PS) to be fit to receive treatment with immunotherapy. 2
  2. Nivolumab will be or is administered as monotherapy. Note: clinicians starting nivolumab plus ipilimumab combination treatment should only use this form after the ipilimumab part of the treatment has been completed. be Please tick appropriate box:
  • Nivolumab given as monotherapy from start of nivolumab therapy or
  • Nivolumab initially given in combination with ipilimumab and then continued as monotherapy
  1. Unless the patient chooses to electively discontinue treatment as outlined in criterion 7, the licensed dose and frequency of nivolumab will be used (i.e. either 240mg every 2 weeks or 480mg every 4 weeks) or 480mg every 8 weeks if the patient is participating in the REFINE trial (NIHR SPMS 50169). in
  2. 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 month of treatment and thereafter on a regular basis. 12.Treatment breaks of up to 12 weeks beyond the expected cycle length are allowed but solely to allow any toxicities to settle. Form b and c are shown on the next page

NHS funded From: 18 May 2016

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CDF Managed Access: NA

NICE Technology Appraisal: TA384 & (NA)

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