Nivolumab [NIV15]

For the treatment of adult patients with unresectable locally advanced or recurrent or metastatic squamous cell carcinoma the oesophagus previously treated with fluoropyrimidine and platinum-based 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 nivolumab monotherapy 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 confirmed diagnosis of squamous cell oesophageal carcinoma or adenosquamous oesophageal carcinoma. Please enter below which type of oesophageal cancer the patient has:
  • squamous cell carcinoma of the oesophagus
  • adenosquamous carcinoma of the oesophagus
  1. The patient has unresectable locally advanced or recurrent or metastatic disease.
  2. The patient has been treated with a fluoropyrimidine- and platinum-based combination chemotherapy for his/her squamous cell carcinoma of the oesophagus and has progressed during or following such treatment or was intolerant of such therapy. Please enter below at what stage in the treatment pathway the previous fluoropyrimidine- and platinum-based combination chemotherapy was given:
  • as neoadjuvant chemotherapy prior to surgery
  • as part of concurrent chemo-radiotherapy
  • as adjuvant chemotherapy
  • as treatment of recurrent or metastatic disease
  1. The patient has an ECOG performance status score of 0 or 1.
  2. Treatment with nivolumab monotherapy will continue as long as clinical benefit is observed or until the development of unacceptable toxicity or withdrawal of patient consent, whichever occurs first. of Note: there is no 2 year stopping rule for the use of nivolumab in this indication. a
  3. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  4. The patient has not received prior treatment with any antibody which targets PD-1 or PD-L1 or PD-L2 or CD137 or OX40 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) unless the patient discontinued or completed checkpoint inhibitor immunotherapy as part of adjuvant therapy without disease progression and at least 6 months has elapsed between the date of the last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease Please mark below which scenario applies to this patient:
  • this patient has not received any previous immunotherapy for squamous cell or adenosquamous cell carcinoma of the oesophagus
  • this patient was previously treated with neoadjuvant platinum-based chemoradiotherapy for squamous cell or adenosquamous carcinoma of the oesophagus and underwent surgery followed by adjuvant nivolumab (NICE TA713) then discontinued or completed treatment with adjuvant nivolumab without disease progression and it has been at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous adjuvant nivolumab immunotherapy and first diagnosis of disease relapse _________ Note: the mandatory interval between the last date of administration of any prior adjuvant immunotherapy and first relapse is at least 6 months. For patients suffering a first relapse within 6-12 months of previous immunotherapy, clinicians should bear in mind the long elimination half-lives of immunotherapies and make individual assessments of the overall benefit/risk ratio of re-treatment with immunotherapy.
  1. A formal medical review as to how treatment with 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 first 8 weeks of treatment.
  2. Where a treatment break of more than 12 weeks beyond the expected 2- or 4-weekly cycle length is needed, I will complete a treatment break form to restart treatment.
  3. Nivolumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 13 September 2021

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CDF Managed Access: NA

NICE Technology Appraisal: TA707 (15 June 2021)

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