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 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 has 3. The patient locally advanced unresectable or recurrent or metastatic disease.

4. 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.
5. 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 %: __________
6. 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: __________
7. 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.
8. The chemotherapy used in combination with nivolumab will be both platinum and fluoropyrimidine-based.
9. Nivolumab will be administered at the licensed doses shown below • Subcutaneously – at a dose of 600mg every 2 weeks, or 1200mg every 4 weeks • Intravenously – at a dose of 240mg every 2 weeks, or 480mg every 4 weeks

Note

Note: Nivolumab at a dose of 360mg, 3-weekly, when given in combination with 3-weekly based chemotherapy is permitted, but this is off-label dosing, so trust procedures for off-label prescribing must be adhered to.

10. 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.
11. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
12. 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

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

13. When 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 approval form to restart treatment.
14. Nivolumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 09 May 2023

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA865 (08 February 2023)

Current Form Version

Note

The data on this page was produced using version 1.376 of the CDF list, downloaded from NHS England’s website on 24 October 2025 at 18:00.

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.

Older Form Versions

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

• NIV21_prior_to_cdf_1.361
• NIV21_prior_to_cdf_1.376