Nivolumab with ipilimumab [NIV24]

Nivolumab plus ipilimumab for previously untreated patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:

1. This application for nivolumab plus ipilimumab 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 patient has either metastatic or locally advanced and inoperable colorectal carcinoma and has not received any previous systemic therapy for this indication.

Note

Note: patients may have received neoadjuvant systemic therapy for non-metastatic disease and/or adjuvant chemotherapy after surgery.

3. The patient’s tumour has a documented presence of microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR) confirmed by validated testing.
4. The patient’s tumour has been determined to have wild type or mutant RAS status and the result is recorded below:

• wild RAS status type

5. 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 status
• BRAF test result not yet reported and the decision to proceed without knowing BRAF status has been discussed with the patient during the consenting process

6. The patient has an ECOG performance status (PS) of 0 or 1.
7. The patient has no symptomatic brain or leptomeningeal metastases.
8. 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 clear evidence of radiologically-assessed 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 or
• 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

Note: this combination of nivolumab plus ipilimumab is not funded after previous treatment with pembrolizumab for MSI-H or dMMR metastatic or locally advanced and inoperable colorectal cancer.

9. Nivolumab will be administered in combination with ipilimumab as follows: nivolumab 240mg and ipilimumab 1mg/Kg are given intravenously in combination for a maximum of 4 cycles every 3 weeks, and then nivolumab is continued as 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
10. Nivolumab will be stopped on disease progression or unacceptable toxicity or withdrawal of patient consent or completion of 2 calendar years of treatment with nivolumab, whichever occurs first.
11. 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 to restart treatment. This MUST be approved before treatment is re- started.
12. Nivolumab and ipilimumab will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

NHS funded From: 27 August 2025

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA1065 (28 May 2025)

Current Form Version

Note

The data on this page was produced using version 1.376 of the CDF list, downloaded from NHS England’s website on 24 October 2025 at 18:00.

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.

Older Form Versions

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

• NIV24_prior_to_cdf_1.361
• NIV24_prior_to_cdf_1.373
• NIV24_prior_to_cdf_1.376