Pembrolizumab monotherapy [PEMB24]
For the subsequent treatment of patients with previously treated unresectable or metastatic COLORECTAL cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:
- 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.
- 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.
- The patient has unresectable or metastatic 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.
- 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
- 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
- The patient has received previous fluoropyrimidine-based combination therapy for unresectable or metastatic colorectal cancer unless the fluoropyrimidine part of the chemotherapy was contraindicated on account of documented DPD deficiency. Please mark below which clinical scenario applies to this patient:
- previous combination therapy for unresectable or metastatic colorectal cancer with fluoropyrimidine-based combination chemotherapy (with oxaliplatin or irinotecan or both)
- previous combination therapy for unresectable or metastatic colorectal cancer (with oxaliplatin and irinotecan or both) but not with fluoropyrimidine-based combination chemotherapy on account of documented DPD deficiency contraindicating the use of fluoropyrimidine-based chemotherapy
- The patient has progressive disease during or following the most recent chemotherapy.
- The patient has an ECOG performance status (PS) of 0 or 1. Note: NHS England does not fund this treatment in patients of ECOG PS 2.
- The patient is unsuitable for treatment with the combination of nivolumab plus ipilimumab. Note: the NICE guidance restricts the use of pembrolizumab in this indication to those patients for whom treatment with the combination of nivolumab plus ipilimumab is unsuitable.
- 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 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
- Pembrolizumab will be administered as monotherapy at a dose of 200mg every 3 weeks or a dose of 400mg every 6 weeks. Note: NHS England recommends the use of 6-weekly pembrolizumab whenever appropriate.
- Pembrolizumab will be stopped at whichever of the following events occurs first: progressive disease or loss of clinical benefit 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).
- 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.
- When a treatment break of more than 12 weeks beyond the expected 3 or 6-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
- Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 19 December 2023
Additional information
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.