Pembrolizumab [PEMB9a]

Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma (form a): REGISTRATION OF START OF PEMBROLIZUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED PEMBROLIZUMAB MONOTHERAPY This form comes in 3 parts. 1. The first part is for patients who are either scheduled to commence pembrolizumab monotherapy or who commenced and continue to receive pembrolizumab monotherapy. 2. The second part of the form which must use the same unique Blueteq identifier is for those benefitting patients who choose to electively discontinue pembrolizumab after 2 or more years of treatment; this second part (patient details be automatically entered) will only appear once the first part of the form is approved and should be completed at the time of elective discontinuation of pembrolizumab. 3. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped pembrolizumab and in whom there is disease progression for which the clinician wishes to re-commence pembrolizumab; this third part of the form (patient details will automatically entered) will only appear once

1. This application has been made by and the first cycle of systemic anti -cancer therapy with pembrolizumab will be/was prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.

Note

Note: if treatment with pembrolizumab has already commenced, it is vital that the treatment start date has been entered in the box above.

2. The patient has a histologically- or cytologically-confirmed diagnosis of malignant melanoma.
3. The patient has unresectable or advanced melanoma.
4. In respect of his/her treatment for unresectable/advanced disease and at the time of starting pembrolizumab, the patient is/was treatment-naïve to systemic therapy, or • Has/had previously only received BRAF/MEK-targeted therapy, or ipilimumab monotherapy or both BRAF/MEK-targeted treatment and ipilimumab monotherapy. • Has a diagnosis of uveal melanoma, and has received treatment with tebentafusp in the first line setting, and has stopped this therapy due to disease progression, or lack of tolerance
5. At the time of commencing pembrolizumab the patient has/had not received prior treatment with any of the following: anti-PD-1, anti-PD-L1, anti-PD-L2 and anti-CD137 treatments unless the patient has received adjuvant immunotherapy with nivolumab or pembrolizumab in which case the patient must have relapsed after the discontinuation of such adjuvant immunotherapy. Please tick appropriate box:

• No prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CD137 treatments or will
• Prior adjuvant immunotherapy with nivolumab or pembrolizumab.

6. There is the future opportunity for patients continuing in a stable disease or a response disease state after 2 or more years of planned treatment to choose to discontinue pembrolizumab and then to re-start pembrolizumab on disease progression as the next systemic therapy and should this option be chosen that both the date of discontinuation must be registered on the second part of this form and the application to re-start pembrolizumab be made on the third part of this form.
7. The patient has a sufficient performance status (PS) to be fit to receive treatment with immunotherapy.
8. Pembrolizumab will be administered as monotherapy unless being administered in the SCIB1-002 study in which case it may be given with SCIB1 (the trial’s Investigational Medicinal Product)
9. Unless the patient chooses to electively discontinue treatment as outlined in criterion 7, the licensed dose and frequency of pembrolizumab will be used (i.e. either 200mg every 3 weeks or 400mg every 6 weeks) or 400mg every 12 weeks if the patient is participating in the REFINE trial (NIHR SPMS 50169). be
10. When 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 requesting a restart of treatment. This must be approved before the pembrolizumab is re-commenced.

NHS funded From: 23 February 2016

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA366 (25 November 2015)

Current Form Version

Note

The data on this page was produced using version 1.377 of the CDF list, downloaded from NHS England’s website on 18 November 2025 at 09:00.

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.

• PEMB9a_prior_to_cdf_1.361
• PEMB9a_prior_to_cdf_1.377