Pembrolizumab [PEMB19]

Pembrolizumab monotherapy for adjuvant treatment after complete tumour resection of renal cell carcinoma in adult patients at increased risk of recurrence following nephrectomy or following nephrectomy and resection of all metastatic disease where the following criteria have been met:

1. An application has been 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. The patient has a histologically documented diagnosis of renal cell carcinoma (RCC). Please indicate below which RCC histology applies to this patient:

• RCC with a clear cell component or
• Papillary RCC or
• Chromophobe RCC or
• Collecting duct RCC (Bellini collecting duct RCC) or
• Medullary RCC
• Mucinous tubular and spindle cell RCC or
• Multilocular cystic RCC or
• XP11 translocation RCC or
• Unclassified RCC

3. At the time of first presentation with RCC, the patient had either loco-regional disease only or had both loco-regional and distant metastatic (M1) disease. Please mark below which pattern of disease at the time of first presentation with RCC applies to this patient:

• loco-regional disease only (M0 disease) or
• loco-regional disease and M1 disease

4. The patient has undergone a partial nephro-protective or radical nephrectomy and complete resection of all known metastatic disease if present with all surgical excision margins being negative i.e. a R0 resection(s) has/have taken place. Please indicate the type of surgery undergone:

• nephrectomy (partial or radical) for M0 disease or
• nephrectomy (partial or radical) and metastasectomy/ metastasectomies in which case the M1 disease must have been completely resected at the time of nephrectomy or within 1 year of nephrectomy

5. The patient has an increased risk of recurrence of RCC after surgery as defined in the 3 categories of ‘intermediate-high’ risk, ‘high’ risk and ‘M1 with no evidence of disease’ as used in the Keynote-564 clinical trial and in pembrolizumab’s marketing authorisation. Please mark below which stage applies to this patient:

• pT2 N0 M0 disease with either Fuhrman grade 4 or sarcomatoid histology (intermediate-high risk) or
• pT3 N0 M0 with any histological grade (intermediate-high risk) or
• pT4 N0 M0 with any histological grade (high risk) or
• any pT N1 M0 with any histological grade (high risk) or
• any pT any N M1 with no evidence of disease after complete resection of both loco-regional disease and all metastatic lesion(s)

6. The patient has been radiologically re-staged after completion of surgery and has no evidence of residual or metastatic disease.
7. No more than 12 weeks have elapsed since the date of nephrectomy or metastasectomy.
8. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or with any other systemic therapy for RCC.
9. The patient has an ECOG performance status (PS) of 0 or 1.
10. Pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or on completion of 1 year in total duration of treatment with pembrolizumab (i.e. after a maximum of 17 x 3-weekly cycles or 9 x 6-weekly cycles of pembrolizumab).
11. 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, which MUST be approved before treatment with pembrolizumab is recommenced.
12. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 17 January 2023

Additional information

Form version: 1.1

CDF Managed Access: NA

NICE Technology Appraisal: TA830 (19 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.