Nivolumab [NIV19]

Nivolumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with high risk muscle invasive urothelial cancer with tumour cell PD-L1 expression of ≥1% and in whom adjuvant treatment with platinum-based chemotherapy is unsuitable where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with adjuvant nivolumab 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 anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically documented diagnosis of muscle invasive urothelial cancer of the bladder, ureter or renal pelvis. Please mark below the site of origin of the urothelial cancer:
  • bladder
  • ureter
  • renal pelvis
  1. The patient’s urothelial cancer has been documented as exhibiting PD-L1 expression on ≥1% of tumour cells as determined by an approved and validated PD-L1 assay. Please document below the actual PD-L1 expression on tumour cells (e.g. if 50%, please type just the number 50): PD-L1 expression in this patient’s tumour cells: __________
  2. The patient was treated with neoadjuvant chemotherapy or not: please mark below as appropriate:
  • yes, the patient was treated with neoadjuvant chemotherapy
  • no, the patient did not receive neoadjuvant chemotherapy
  1. The patient had M0 disease prior to surgery and has undergone a complete resection of the muscle invasive urothelial cancer with all surgical margins negative for tumour i.e. a R0 resection has taken place.
  2. The pathological TNM stage determined on this patient’s surgical urothelial cancer specimen represents high risk disease as defined by the following:
  • if there has been prior neoadjuvant chemotherapy, the pathological stage of the resected tumour must be ypT2-ypT4a or any ypN+ stage
  • or if there has not been any neoadjuvant chemotherapy, the pathological stage of the resected tumour must be pT3 or pT4a or any pN+ stage. Please mark below which option applies to this patient:
  • following neoadjuvant chemotherapy, the high risk criterion has been met by having ypT2-ypT4a ypN0 disease
  • following neoadjuvant chemotherapy, the high risk criterion has been met by having ypN+ disease
  • in the absence of neoadjuvant chemotherapy, the high risk criterion has been met by having pT3-pT4a pN0 disease
  • in the absence of neoadjuvant chemotherapy, the high risk criterion has been met by having pN+ disease
  1. The patient has not been treated with any adjuvant chemotherapy following resection of the urothelial tumour.
  2. The patient has had an informed consent discussion as to the options of adjuvant systemic therapies and the conclusion is that adjuvant platinum-based chemotherapy is unsuitable. Please mark below the reason as to why adjuvant chemotherapy is unsuitable in this patient:
  • the patient had neoadjuvant chemotherapy
  • the lack of robust RCT data in bladder cancer for the benefit of adjuvant chemotherapy
  • the toxicity profile of adjuvant platinum-based chemotherapy
  • the refusal by the patient to have adjuvant platinum-based chemotherapy
  1. The patient underwent radical surgery less than 4 months prior to the expected date for the start of adjuvant nivolumab therapy.
  2. The patient has been radiologically re-staged after surgery such that the patient remains disease-free within 1 month of the expected date for the start of adjuvant nivolumab therapy.
  3. 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.
  4. The patient has an ECOG performance status (PS) of 0 or 1.
  5. Nivolumab 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 nivolumab (i.e. after a maximum of 13 x 4-weekly cycles).
  6. A formal medical review as to how nivolumab is being tolerated and whether treatment with nivolumab should continue or not will be scheduled to occur at least by the end of the second month of treatment.
  7. When a treatment break of more than 3 months beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of Covid-19.
  8. Nivolumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 08 November 2022

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CDF Managed Access: NA

NICE Technology Appraisal: TA817 (10 August 2022)

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