Nivolumab and ipilimumab [NIV10]

For patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic or locally advanced and inoperable colorectal cancer after prior fluoropyrimidine-based chemotherapy for metastatic disease where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with nivolumab plus 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 either metastatic or locally advanced and inoperable colorectal carcinoma.
4. The patient’s tumour has a documented presence of microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR) confirmed by validated testing.
5. The patient’s tumour has been determined to have wild type or mutant RAS status and the result is recorded below:

• wild type RAS status
• mutant RAS status

6. The patient’s tumour has been determined to have wild type or mutant BRAF status and the result is recorded below:

• wild type BRAF status
• mutant BRAF status2.

7. The patient has received previous systemic fluoropyrimidine-based therapy for metastatic colorectal cancer unless the fluoropyrimidine part of chemotherapy was contra-indicated on account of documented DPD deficiency. Please mark below which clinical scenario applies to this patient:

• previous systemic therapy for metastatic colorectal cancer with fluoropyrimidine-based chemotherapy
• previous systemic therapy for metastatic colorectal cancer but not with fluoropyrimidine-based chemotherapy on account of documented DPD deficiency contraindicating the use of fluoropyrimidine-based chemotherapy

8. The patient has an ECOG performance status (PS) of 0 or 1.
9. The patient has no symptomatic brain or leptomeningeal metastases.
10. The patient has not received prior treatment with an anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody unless the patient was enrolled in the NEOPRISM-CRC clinical trial (NIHR CPMS ID 52000) and did not have radiologically-assessed evidence of progressive disease at the end of neoadjuvant pembrolizumab therapy. Please mark below which clinical scenario applies to this patient:

• the patient has not received any previous anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody therapy for metastatic colorectal cancer
• the patient was enrolled in the NEOPRISM-CRC clinical trial ((NIHR CPMS ID:52000) and did not have clear evidence of radiologically-assessed progressive disease at the end of neoadjuvant pembrolizumab therapy Note: this combination of nivolumab plus ipilimumab is not funded after previous treatment with pembrolizumab for MSI-H or dMMR metastatic colorectal cancer.

11. Nivolumab will be administered in combination with ipilumumab as follows: nivolumab 3mg/Kg and ipilimumab 1mg/Kg are given in combination for a maximum of 4 cycles every 3 weeks and then nivolumab is continued as monotherapy as either 2-weekly cycles of nivolumab at a dose of 240mg or if the patient is stable and well as 4-weekly cycles of nivolumab monotherapy 480mg.
12. Nivolumab will be stopped on disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. Note: there is no stopping rule for nivolumab in this metastatic colorectal cancer indication and hence patients continuing to benefit from nivolumab after 2 years of treatment can continue if the patient and clinician agree. Note: once nivolumab is stopped for disease progression or unacceptable toxicity or withdrawal of patient consent, nivolumab cannot be re-started.
13. A formal medical review as to whether treatment with nivolumab and ipilimumab should continue will occur at least by the end of the 2nd 3-weekly cycle of treatment.
14. Where 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 to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
15. Nivolumab and ipilimumab will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

NHS funded From: 26 October 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA716 (28 July 2021)

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.