Published

May 11, 2025

Nivolumab in combination with platinum and fluoropyrimidine-based chemotherapy [NIV21]

For previously untreated unresectable advanced or recurrent or metastatic squamous cell carcinoma of the oesophagus with a tumour cell PD-L1 expression of 1% or more and a PD-L1 combined positive score of <10 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 in combination with chemotherapy 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-1 or anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of squamous cell carcinoma of the oesophagus or adenosquamous carcinoma of the oesophagus. Please mark below which histology applies to this patient:
  • squamous cell carcinoma of the oesophagus
  • adenosquamous carcinoma of the oesophagus
  1. The patient has locally advanced unresectable or recurrent or metastatic disease.
  2. The patient has not received any previous systemic therapy for locally advanced unresectable or recurrent or metastatic disease ie I confirm that nivolumab plus chemotherapy will be 1st line systemic therapy for locally advanced unresectable or recurrent or metastatic disease. In addition, please mark below whether the patient has/has not previously received any systemic therapy for earlier stage disease:
  • this patient has not received any previous systemic therapy for squamous cell or adenosquamous carcinoma of the oesophagus
  • this patient was previously treated with neoadjuvant chemotherapy for squamous cell or adenosquamous carcinoma of the oesophagus and underwent surgery and has since had disease progression
  • this patient was previously treated with adjuvant chemotherapy for squamous cell or adenosquamous carcinoma of the oesophagus after surgery and has since had disease progression
  • this patient was previously treated with concurrent or sequential chemo-radiotherapy for squamous cell or adenosquamous carcinoma of the oesophagus and has since had disease progression
  1. An approved and validated test has demonstrated that the tumour cell PD-L1 expression is 1% or more. Please document the actual tumour cell PD-L1 expression result below: Tumour cell PD-L1 expression %: __________
  2. An approved and validated test has demonstrated that the tumour has a PD-L1 expression with a combined positive score (CPS) of <10. Please document the actual PD-L1 combined positive score (CPS) below: PD-L1 CPS: __________
  3. The 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 the appropriate scenario below for this patient: this patient has not received any previous immunotherapy for squamous cell or adenosquamous 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 TA 713) then discontinued or completed treatment with adjuvant nivolumab without disease progression and this was 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.
  4. The chemotherapy used in combination with nivolumab will be both platinum and fluoropyrimidine-based.
  5. Nivolumab will be administered at the licensed doses of either 240mg 2-weekly or 480mg 4-weekly initially in combination with platinum and fluoropyrimidine-based chemotherapy and subsequently as monotherapy. Note: nivolumab at a dose of 360mg given 3-weekly when in combination with 3-weekly chemotherapy regimens may be used but such dosing is off-label and so Trust procedures for the prescribing of off-label dosing must be followed. Note: NHS England expects the 4-weekly dosing of nivolumab to be used once chemotherapy has been discontinued.
  6. The patient has an ECOG performance status (PS) of 0 or 1 and is fit for platinum and fluoropyrimidine-based chemotherapy in combination with nivolumab.
  7. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  8. Nivolumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or after 2 calendar years of treatment regardless of any treatment breaks. Note: the 2 year stopping rule for nivolumab in this indication is in the marketing authorisation and its measurement as a 2 calendar year stopping rule was part of the company submission to NICE for the clinical and cost effectiveness of nivolumab in this indication. Note: once nivolumab is stopped after 2 calendar years of treatment, it cannot be re-started.
  9. A formal medical review as to how nivolumab plus chemotherapy is being tolerated and whether nivolumab should continue or not will be scheduled to occur at least by the end of the second cycle of treatment.
  10. When a treatment break of more than 3 months beyond the expected 2- or 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break to restart treatment.
  11. Nivolumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 09 May 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA865 (08 February 2023)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link

Older Form Versions

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