Nivolumab and ipilimumab [NIV18]
Nivolumab in combination with ipilimumab for treating advanced melanoma
- 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.
- I confirm that as the prescribing clinician I am fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to checkpoint inhibitor treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
- I confirm the patient has unresectable stage III or stage IV histologically confirmed melanoma.
- I confirm that 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.
- I confirm that 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 adjuvant 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. Please mark below previous systemic therapies received: no previous systemic therapy of any kind; or prior adjuvant therapy with adjuvant 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
- I confirm that the patient is of ECOG performance status (PS) 0 or 1.
- I confirm that the patient has no symptomatic brain metastases or leptomeningeal metastases currently requiring steroids for symptom control.
- Nivolumab will be used at a dose of 1mg/Kg every 3 weeks for the first 4 cycles (i.e. when in combination with ipilimumab) and then as subsequent monotherapy at the licensed dose and frequency of nivolumab (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). * 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)
- I confirm that a formal medical review to assess the tolerability of treatment with nivolumab and ipilimumab will be scheduled to occur by the start of the 3rd 3-weekly cycle of treatment and thereafter on a regular basis.
- I confirm that when a treatment break of more than 12 weeks beyond the expected 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.
- I confirm that nivolumab and ipilimumab will be prescribed and administered as outlined in their respective Summary of Product Characteristics (SPCs) for this indication.
[NHS funded]{.badge .rounded-pill .bg-success} From: 25 October 2016
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