Pembrolizumab [PEMB20]

Pembrolizumab for the adjuvant treatment of newly diagnosed and completely resected stage IIB or stage IIC malignant melanoma where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with adjuvant pembrolizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient has a documented histological diagnosis of malignant melanoma. Please indicate whether the melanoma is BRAF V600 mutation positive or not:

• BRAF V600 mutation positive or
• BRAFV600 mutation negative

3. The patient has melanoma which has been staged as stage IIB or stage IIC disease according to the AJCC 8th edition. Please state which stage disease the patient has:

• Stage IIB disease or
• Stage IIC disease

4. Complete resection has taken place for stage II disease.
5. The patient is treatment naïve to any systemic therapy for malignant melanoma and in particular has not previously received any immunotherapy with any check point inhibitors or BRAF V600 inhibitors or MEK inhibitors.

Note

Note: NHS England does not commission any adjuvant immunotherapy with checkpoint inhibitors for stage III disease in patients who have previously received adjuvant immunotherapy for stage IIB or IIC disease.

6. The prescribing clinician has discussed with the patient the benefits and toxicities of adjuvant pembrolizumab in stage IIB/IIC disease and has used the expected median figures below for melanoma-specific survival in relation to the risk of disease relapse if a routine surveillance policy is followed:

• for stage IIB disease, the 5 and 10 year figures for melanoma-specific survival probabilities with routine surveillance are 87% and 82%, respectively
• for stage IIC disease, the 5 and 10 year figures are 82% and 75%, respectively

7. The patient has an ECOG performance status of either 0 or 1.
8. Adjuvant pembrolizumab will commence no more than 3 months after the date of surgery which documented the complete resection of stage II melanoma.
9. Treatment with pembrolizumab monotherapy will be continued for a maximum of 12 months from the start of treatment (or a maximum of 9 cycles if given 6-weekly) in the absence of disease recurrence, unacceptable toxicity or withdrawal of patient consent.
10. When a treatment break of more than 12 weeks beyond the expected 3-weekly, or 6-weekly cycle length is needed, I will complete a treatment break approval form which MUST be approved before treatment with pembrolizumab is recommenced.
11. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 24 January 2023

Additional information

Form version: 1.0

CDF Managed Access: NA

NICE Technology Appraisal: TA837 (26 October 2022)

Current Form Version

Note

The data on this page was produced using version 1.387 of the CDF list, downloaded from NHS England’s website on 24 February 2026 at 11:00.

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.