Avelumab [AVE4]

Avelumab monotherapy for the maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have just completed and not progressed on 1st line platinum-containing combination chemotherapy where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with avelumab monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The 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, hepatitis and skin toxicity.
3. The patient has a histologically confirmed diagnosis of urothelial carcinoma.
4. The patient has locally advanced or metastatic disease.
5. The patient has recently completed 1st line combination chemotherapy with either the combination of gemcitabine plus cisplatin or gemcitabine plus carboplatin. Please enter below whether the patient commenced 1st line chemotherapy with either gemcitabine plus cisplatin or gemcitabine plus carboplatin:

• 1st line commenced with gemcitabine plus cisplatin
• 1st line chemotherapy commenced with gemcitabine plus carboplatin.

6. The patient has completed at least 4 cycles and no more than 6 cycles of combination chemotherapy with gemcitabine plus cisplatin or gemcitabine plus carboplatin.
7. The patient had a CT or MR scan after completing this chemotherapy and has been shown to have no evidence of progressive disease compared with the scans performed prior to chemotherapy and with any scans whilst on chemotherapy. Please enter below the response status of the tumour as assessed radiologically at the end of chemotherapy:

• complete response to treatment at the end of 1st line chemotherapy
• partial response to treatment at the end of 1st line chemotherapy
• stable disease at the end of 1st line chemotherapy. Note: patients who have responded to chemotherapy as demonstrated on an interval scan during chemotherapy but whose scans at the end of chemotherapy show progressive disease are NOT eligible for maintenance avelumab therapy.

8. The patient will commence treatment with avelumab within 4 to 10 weeks of receiving the last dose of chemotherapy.
9. The patient has an ECOG performance status score of 0 or 1.
10. Maintenance treatment with avelumab monotherapy will continue until disease progression or symptomatic deterioration or unacceptable toxicity or withdrawal of patient consent or after a maximum of 5 calendar years of avelumab treatment (as measured from cycle 1 day 1 of avelumab administration), whichever of these events occurs first.
11. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
12. 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 (CTL-4) antibody unless the patient completed or discontinued checkpoint inhibitor immunotherapy as part of adjuvant or neoadjuvant therapy without disease progression on treatment and at least 12 months elapsed between the date of last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission any re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. Please mark below if the patient has received previous checkpoint inhibitor therapy and in which setting:

• the patient has never received any immunotherapy for urothelial cancer. If so, please type ‘n/a’ in the ‘Time gap’ box below or
• the patient has previously been treated with adjuvant immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse or
• the patient has previously been treated with neoadjuvant treatment containing immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant or maintenance checkpoint inhibitor immunotherapy and first diagnosis of disease relapse: ________

13. Avelumab is being given as monotherapy.
14. A formal medical review as to how treatment with avelumab is being tolerated and whether treatment with avelumab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
15. When a treatment break of more than 12 weeks beyond the expected 2-weekly cycle length is needed, I will complete a treatment break form to restart treatment.
16. Avelumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 15 January 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA666 (16 December 2020)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 13 May 2025 at 19:45.

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.