Nivolumab in combination with relatlimab (Opdualag ®) [NIVREL1]
As first immunotherapy for treating unresectable or metastatic melanoma patients aged 12 years or more where the following criteria have been met:
- This application is being made by and the first cycle of systemic anti-cancer therapy with the combination of nivolumab plus relatlimab 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 checkpoint inhibitor treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis, myocarditis and skin toxicities.
- The patient has unresectable stage III or stage IV histologically confirmed melanoma.
- The patient is aged 12 years or older.
- 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. Note: treatment with nivolumab plus relatlimab is not funded for any patients with unresectable or metastatic melanoma who have already started treatment with pembrolizumab monotherapy or nivolumab monotherapy or nivolumab plus ipilimumab.
- The patient is completely treatment naïve for systemic therapy for melanoma or has only received specifically allowed prior systemic therapy. Allowed prior therapies are: 1) prior adjuvant therapy with adjuvant nivolumab or pembrolizumab or 2) prior immune checkpoint inhibitors for the advanced disease indication only when given as part of a clinical trial either as monotherapy or in combination with ipilimumab or 3) BRAF/MEK inhibitor targeted therapies when given for the adjuvant indication or 4) BRAF/MEK inhibitor targeted therapies when given as 1st line treatment for the advanced disease indication. Please mark below previous systemic therapies received: in
- no previous systemic therapy of any kind for melanoma or
- prior adjuvant therapy with adjuvant nivolumab or pembrolizumab monotherapies or
- prior immune checkpoint inhibitors for the advanced disease indication only 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 the adjuvant indication or
- BRAF/MEK inhibitor targeted therapies when given as 1st line treatment for the advanced disease indication or
- a combination above allowed treatment of the options
- The patient is of ECOG performance status (PS) 0 or 1 or if aged 12-17 years is of Lansky performance score of 80% or more.
- The patient has no symptomatic brain metastases or leptomeningeal metastases currently requiring steroids for symptom control.
- Nivolumab 480mg with relatlimab 160mg in a combined formulation (Opdualag®) will be used every 4 weeks. Note: this dose is established for adolescent patients weighing at least 30Kg.
- Nivolumab plus relatlimab will be given until whichever of the following occurs first: progressive disease or loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent or two calendar years have passed since the date of first treatment with nivolumab plus relatlimab. Note: NICE’s recommendation as to the clinical and cost effectiveness of nivolumab plus relatlimab was based on a 2 calendar year stopping rule in the company’s NICE submission. There is therefore no funding for nivolumab and relatlimab after 2 calendar years have passed since the date of first treatment. Note: in patients who discontinued nivolumab plus relatlimab after 2 calendar years have passed since the date of first treatment and who subsequently relapse, a re-start of further treatment with nivolumab plus relatlimab is not funded.
- During the consenting process to start treatment with nivolumab plus relatlimab the patient has been informed of the maximum treatment duration of 2 calendar years as measured from the date of first treatment.
- A formal medical review to assess the tolerability of treatment with nivolumab plus relatlimab will be scheduled to occur by the start of the 3rd 4-weekly cycle of treatment and thereafter on a regular basis.
- 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.
- Nivolumab plus relatlimab will be otherwise prescribed and administered as outlined in Opdualag’s® Summary of Product Characteristics (SPC) for this indication.
NHS funded From: 07 May 2024
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
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.