Published

May 11, 2025

Nivolumab in combination with ipilimumab [NIV20]

For treatment of unresectable malignant mesothelioma previously untreated with systemic therapy where the following criteria have been met:

  1. This application for nivolumab in combination with ipilimumab is being made by and the first cycle of systemic anti-cancer therapy with nivolumab in combination with ipilimumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  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, hepatitis and skin toxicity.
  3. The patient has a histologically or cytologically confirmed diagnosis of mesothelioma.
  4. The mesothelioma is of pleural or non-pleural origin. Please indicate below the site of origin of the mesothelioma in this patient:
  • the pleura or
  • the peritoneum or
  • the pericardium or
  • the tunica vaginalis in the testis
  1. The histological subtype of mesothelioma as to whether the mesothelioma in this patient is of epithelioid type or non-epithelioid type (sarcomatoid or mixed [biphasic] histological types) or the type cannot be determined. Please indicate below the histological subtype of mesothelioma in this patient:
  • the mesothelioma is of epithelioid type or
  • the mesothelioma is of non-epithelioid (sarcomatoid or biphasic) type or
  • the mesothelioma type cannot be determined
  1. The patient has unresectable disease.
  2. The patient has not previously received any systemic therapy for mesothelioma (neither cytotoxic chemotherapy nor immunotherapy) unless the patient was started on treatment with nivolumab and ipilumumab via the EAMS scheme and all other treatment criteria on this form are fulfilled. Please mark below which of these 2 clinical scenarios applies to this patient:
  • The patient has not received prior systemic treatment for mesothelioma including chemotherapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies.
  • Received prior treatment with nivolumab and ipilumumab via EAMS scheme and all other treatment criteria on this form are fulfilled Note: patients previously treated with cytotoxic chemotherapy for mesothelioma or with immunotherapy for mesothelioma are not eligible to receive nivolumab plus ipilimumab.
  1. The patient has an ECOG performance status of 0 or 1.
  2. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting nivolumab in combination with ipilimumab.
  3. Nivolumab and ipilimumab will not be combined with any other systemic anti-cancer therapy.
  4. Nivolumab will be administered at a flat dose of 360mg every 3 weeks. Note: if nivolumab is discontinued because of toxicity, ipilimumab must also be stopped.
  5. Ipilimumab will be administered at a dose of 1mg/Kg every 6 weeks. Note: if ipilimumab is discontinued because of toxicity, nivolumab can be continued as monotherapy.
  6. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment or completion of 2 years of treatment (a maximum of 35 cycles of nivolumab and a maximum of 17 cycles of ipilimumab), whichever is the sooner. Note: the registration trial for this indication (Checkmate743) had a 2 year stopping rule in the trial design and NICE’s assessment of clinical and cost effectiveness was based on a treatment duration of nivolumab plus ipilimumab that reflected the 2 year stopping rule in Checkmate743.
  7. A first formal medical review as to whether treatment with nivolumab in combination with ipilimumab should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  8. When a treatment break of more than 12 weeks beyond the expected 6-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  9. The next appropriate line of therapy would be platinum-based chemotherapy in combination with pemetrexed if the patient is fit enough to receive such treatment.
  10. Nivolumab and ipilimumab will be used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 16 September 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA818 (17 August 2022)

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.

Older Form Versions

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