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:

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.
The prescribing clinician is am 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.
The patient has either metastatic or locally advanced and inoperable colorectal carcinoma.
The patient’s tumour has a documented presence of microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR) confirmed by validated testing..
The patient’s tumour has been determined to have wild type or mutant RAS status and the result is recorded below:

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

The patient has not received any previous systemic therapy for this metastatic or locally advanced and inoperable indication.
The patient has an ECOG performance status (PS) of 0 or 1.
The patient has no symptomatic brain or leptomeningeal metastases.
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: 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.

Nivolumab will be administered in combination with ipilimumab as follows: nivolumab 240mg and ipilimumab 1mg/Kg are given in combination for a maximum of 4 cycles every 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.
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.
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.
When 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.
Nivolumab and ipilimumab will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

CDF funded From: NA

Additional information

Form version:

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Important

This is an older version of the form. To view the most up to date form follow this link

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