Avelumab in combination with axitinib [AVE3]

For use in treatment-naïve patients with advanced renal cell carcinoma where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with the combination of avelumab and axitinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
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 checkpoint inhibitor treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and other immune-related adverse reactions.
3. The patient has unresectable locally advanced or metastatic renal cell carcinoma (RCC) which has either a clear cell component or is one of the types of RCC as indicated below. 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 or
• Mucinous tubular and spindle cell RCC or
• Multilocular cystic RCC or
• XP11 translocation RCC or
• Unclassified RCC

4. The prescribing clinician confirms below the risk status as assessed by the International Metastatic RCC Database Consortium (IMDC) system which scores 1 point for each of the following 6 factors – a score of 0 indicates good risk disease, a score of 1-2 indicates intermediate risk and a score of 3-6 denotes poor risk: The IMDC factors are:

• less than 1 year from time of initial diagnosis of RCC to now
• a Karnofsky performance status of <80%
• the haemoglobin level is less than the lower limit of normal
• the corrected calcium level is >2.5mmol/L
• the platelet count is greater than the upper limit of normal
• the absolute neutrophil count is greater than the upper limit of normal. Please indicate below whether the patient is in the good or intermediate or poor risk prognostic group:
• good risk disease (IMDC score of 0) or
• intermediate risk disease (IMDC score of 1 or 2) or
• poor risk disease (IMDC score of 3-6)

5. The patient is either completely treatment naïve for systemic immune-modulatory therapy for RCC or if the patient has received prior systemic immune-modulatory therapy in the context of adjuvant/neoadjuvant therapy, then such treatment was completed 12 or more months previously and the patient meets all other criteria listed here. Please mark below whether or not previous systemic immune-modulatory therapy has been received in the adjuvant/neoadjuvant setting:

• no previous adjuvant/neoadjuvant systemic immune-modulatory therapy of any kind and the patient is treatment naïve for the locally advanced/metastatic RCC indication or
• prior adjuvant/neoadjuvant therapy with immune-modulatory therapies for RCC anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD L2, anti-CD137 or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibodies and last dose received by the patient was 12 or more months prior to this application and the patient is treatment-naïve for the locally advanced/metastatic RCC indication Please mark in the box the time since end of treatment with adjuvant/neoadjuvant immune-modulatory therapy: _________

6. The patient has an ECOG performance status of 0 or 1.
7. The patient has no symptomatic brain metastases or leptomeningeal metastases currently requiring steroids for symptom control.
8. The patient is to be treated until loss of clinical benefit or excessive toxicity or patient choice, whichever is the sooner.

Note

Note: there is no stopping rule as to the maximum treatment duration of avelumab plus axitinib in this indication. Note: if either avelumab or axitinib has to be permanently discontinued on account of toxicity, treatment with the other drug can be continued as monotherapy as long as there is no evidence of progressive disease.

9. Avelumab and axitinib will otherwise be prescribed and administered as outlined in their respective Summary of Product Characteristics (SPCs).
10. A formal medical review to assess the tolerability of treatment with avelumab and axitinib will be scheduled to occur at least by the start of the 3rd 4-weekly cycle of treatment and thereafter on a regular basis.
11. Treatment breaks of up to 12 weeks beyond the expected 4-weekly cycle length are allowed but solely to allow any toxicities to settle.
12. If the disease progresses on the avelumab and axitinib combination and further systemic therapy is appropriate, the next line of treatment will be chosen from those options which are routinely commissioned ie for the next line of systemic therapy, there will be use of one choice of the following (mainly incorporating TKI options which have multiple modes of action [so-called ‘dirty’ TKIs)]: the currently commissioned 2nd line options of cabozantinib or lenvatinib plus everolimus or everolimus monotherapy or the currently commissioned 1st line options of sunitinib (still on label as 2nd line treatment) or pazopanib (off label as 2nd line treatment, or tivozanib (off-label as 2nd line treatment).

CDF funded From: 31 July 2020

Additional information

Form version: -

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.380 of the CDF list, downloaded from NHS England’s website on 25 December 2025 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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• AVE3_prior_to_cdf_1.361
• AVE3_prior_to_cdf_1.380