Pembrolizumab [PEMB14]

For the 1st line treatment of patients with either metastatic or locally advanced and inoperable colorectal cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with pembrolizumab monotherapy 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. Wild type or mutant RAS status has been determined on this patient’s tumour and the result is recorded below:

• wild type RAS status
• mutant RAS status
• Test result not yet reported and the decision to proceed without knowing RAS status has been discussed with the patient during consenting process.

6. Wild type or mutant BRAF status has been determined on this patient’s tumour and the result is recorded below:

• wild type BRAF status
• mutant BRAF status
• Test result not yet reported and the decision to proceed without knowing BRAF status has been discussed with the patient during consenting process.

7. The patient has not received previous systemic therapy for metastatic colorectal cancer unless this was given with neoadjuvant intent. Please mark below which clinical scenario applies to this patient:

• no previous systemic therapy for metastatic colorectal cancer and no previous neoadjuvant chemotherapy for metastatic disease
• previous systemic therapy for metastatic colorectal cancer has been solely with neoadjuvant intent for the metastatic indication Note: patients may of course have previously received neoadjuvant systemic therapy for non-metastatic disease and/or adjuvant chemotherapy after surgery.

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

11. Pembrolizumab will be administered as monotherapy at a dose of 200mg every 3 weeks or a dose of 400mg every 6 weeks.
12. Pembrolizumab will be stopped on disease progression or unacceptable toxicity or withdrawal of patient consent or after a total treatment duration of 2 years (or a maximum of 35 3-weekly cycles or the equivalent number of 6- weekly cycles to result in a total treatment duration of 2 years), whichever of these events occurs first.
13. A formal medical review as to whether treatment with pembrolizumab should continue will occur at least by the end of the 2nd month of treatment.
14. Where a treatment break of more than 12 weeks beyond the expected 3 or 6-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. As part of this consenting process, I have explained to the patient that when compared with chemotherapy the risk of dying is greater for pembrolizumab in the first 4 months of treatment and that the long term benefit in overall survival with pembrolizumab occurs after this initial treatment period.
16. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 21 September 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA709 (23 June 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.