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 second part of the form has been approved.

  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: if treatment with pembrolizumab has already commenced, it is vital that the treatment start date has been entered in the box above.
  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 and hepatitis.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of malignant melanoma.
  4. The patient has unresectable or advanced melanoma.
  5. 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.
  6. 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.
  7. 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.
  8. The patient has a sufficient performance status (PS) to be fit to receive treatment with immunotherapy.
  9. 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)
  10. 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 be the every 12 weeks if the patient is participating in the REFINE trial (NIHR SPMS 50169).
  11. I confirm that a formal medical review to assess the tolerability of treatment with pembrolizumab will be scheduled to occur by the start of the 3rd 3-weekly cycle of treatment (or equivalent if having 6 weekly dosing) and thereafter on a regular basis.
  12. Treatment breaks of up to 12 weeks beyond the expected cycle length are allowed but solely to allow any toxicities to settle.

[NHS funded]{.badge .rounded-pill .bg-success} From: 23 February 2016

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CDF Managed Access: NA

NICE Technology Appraisal: TA366 (25 November 2015)

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