Durvalumab with gemcitabine and cisplatin [DUR8]

For neoadjuvant treatment then alone for adjuvant treatment of muscle-invasive bladder cancer where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with durvalumab (in combination with gemcitabine and cisplatin chemotherapy) 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 or cytologically determined diagnosis of resectable muscle-invasive bladder cancer, and the intent is to treat the patient with a radical cystectomy following systemic neo-adjuvant treatment.
3. The patient has disease which is staged as below

• T2-T4a and
• N0 or N1 and
• M0

4. The patient has not received any prior chemotherapy or immunotherapy for the treatment of muscle-invasive bladder cancer.
5. The patient has had no prior treatment with anti–CTLA‑4, anti–PD‑1, anti–PD‑L1, or anti–PD‑L2 antibodies for a bladder cancer indication.
6. In the neo-adjuvant phase, durvalumab will be given alongside gemcitabine and cisplatin chemotherapy, at a dose of 1,500mg every THREE weeks, for FOUR cycles prior to surgery.
7. Treatment with adjuvant durvalumab monotherapy will be given at a dose of 1,500mg every FOUR weeks.
8. Treatment with adjuvant durvalumab monotherapy will continue until disease progression or unacceptable toxicity or withdrawal of patient consent or for a maximum of EIGHT doses post-surgery, whichever occurs first.
9. The patient has a current ECOG performance status of 0 or 1.
10. When a treatment break of more than 12 weeks beyond the expected 3-, or 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment. This must be approved before durvalumab is re-commenced.
11. Durvalumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 10 February 2026

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