Nivolumab and ipilimumab [NIV18]

Nivolumab in combination with ipilimumab for treating advanced melanoma

1. I confirm that this application has been made by and the first cycle of systemic anti-cancer therapy with the combination of ipilimumab and nivolumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has unresectable stage III or stage IV histologically confirmed melanoma.
3. The patient has not received previous treatment for this indication of unresectable or metastatic melanoma with any of the following: anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD- L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibodies.
4. The patient is completely treatment naïve for systemic therapy for melanoma or has only received allowed prior systemic therapy. Allowed prior therapies are: 1) prior adjuvant therapy with nivolumab or pembrolizumab or 2) prior immune checkpoint inhibitors when given as part of a clinical trial either as monotherapy or in combination with ipilimumab and/or 3) BRAF/MEK inhibitor targeted therapies when given for adjuvant indication 4) BRAF/MEK inhibitor targeted therapies when given for advanced disease indication 5) First line tebentafusp, which has had to be stopped due to disease progression, or lack of tolerance, in patients with uveal melanoma Please mark below previous systemic therapies received:

• no previous systemic therapy of any kind; or
• prior adjuvant therapy with nivolumab or pembrolizumab
• or prior immune checkpoint inhibitors when given as part of a clinical trial either as monotherapy or in combination with ipilimumab
• or BRAF/MEK inhibitor targeted therapies when given for adjuvant indication
• or BRAF/MEK inhibitor targeted therapies when given for advanced disease
• or a combination of the above allowed treatment options
• or First line tebentafusp, which has had to be stopped due to disease progression, or lack of tolerance, in patients with uveal melanoma

5. The patient is of ECOG performance status (PS) 0 or 1.
6. The patient has no symptomatic brain metastases or leptomeningeal metastases currently requiring steroids for symptom control.
7. Nivolumab will be used at a dose of 1mg/Kg IV every 3 weeks for the first 4 cycles (i.e. when in combination with ipilimumab) and then as subsequent monotherapy at the licensed dose, frequency, and route 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 or 480mg IV every 8 weeks if the patient is participating in the REFINE trial (NIHR SPMS 50169). * For patients entered into the NIHR clinical trial reference number CANC44182, it is acceptable to continue to use nivolumab monotherapy with the mg/kg dosing schedule. ** For patients entered into the SCIB1-002 study (NIHR clinical trial ID 40068) nivolumab plus ipilimumab and then nivolumab monotherapy may be administered with the SCIB1 or iSCBI1+ vaccines (the trial’s Investigational Medicinal Products)
8. When a treatment break of more than 12 weeks beyond the expected 2-, 3-, 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 ipilimumab and/or nivolumab are re-commenced
9. Nivolumab and ipilimumab will be prescribed and administered as outlined in their respective Summary of Product Characteristics (SPCs) for this indication.

NHS funded From: 25 October 2016

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA400 (27 July 2016)

Current Form Version

Note

The data on this page was produced using version 1.377 of the CDF list, downloaded from NHS England’s website on 18 November 2025 at 09:00.

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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• NIV18_prior_to_cdf_1.361
• NIV18_prior_to_cdf_1.377