Durvalumab in combination with gemcitabine and cisplatin [DUR2]

For the 1st line treatment of patients with locally advanced or unresectable or recurrent or metastatic biliary tract 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 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- or cytologically-confirmed diagnosis of adenocarcinoma of the biliary tract which comprises intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gall bladder carcinoma. Please mark below which of these 3 sites of disease applies to this patient:

• intrahepatic cholangiocarcinoma
• extrahepatic carcinoma
• gall bladder carcinoma Note: a patient with a primary extrahepatic cholangiocarcinoma sited at the ampulla is eligible for treatment with durvalumab plus gemcitabine and cisplatin as the tumour arises from the biliary epithelium. Note: a patient with a primary pancreatic or small bowel carcinoma which is sited at the ampulla is not eligible for access to durvalumab plus gemcitabine and cisplatin.

4. The patient has locally advanced or unresectable or recurrent or metastatic disease.
5. The patient has not received previous chemotherapy for the locally advanced or unresectable or recurrent or metastatic biliary tract cancer indication unless the patient has been enrolled on the SAFIR ABC-10 Precision Medicine clinical trial (see criterion 6 below for further detail). Note: patients who have received prior adjuvant or neoadjuvant chemotherapy are eligible for durvalumab plus gemcitabine and cisplatin provided that the adjuvant or neoadjuvant chemotherapy did not contain the combination of gemcitabine and cisplatin.
6. The patient has not been previously treated with the combination of gemcitabine plus cisplatin unless the patient has been enrolled in the SAFIR ABC-10 Precision Medicine clinical trial and has been randomised to the experimental (targeted therapy) arm and has now progressed on or experienced unacceptable toxicity with the targeted agent and is fit for further treatment with gemcitabine plus cisplatin and durvalumab. Such patients must NOT have shown any evidence of disease progression during the initial four cycles of gemcitabine plus cisplatin and durvalumab.
7. The patient has an ECOG performance status (PS) of 0 or 1. Note: NHS England does not fund this treatment in patients of ECOG PS 2.
8. The patient has no symptomatic brain or leptomeningeal metastases.
9. The patient has NOT received prior treatment with an anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody unless the patient has been enrolled in the SAFIR ABC-10 clinical trial as per criterion 6 and is fit for further treatment with gemcitabine plus cisplatin and durvalumab.
10. Durvalumab 1500mg will be administered in combination with gemcitabine and cisplatin every 3 weeks for a maximum of 8 cycles and then as monotherapy at a dose of 1500mg every 4 weeks.
11. Durvalumab will be stopped at whichever of the following events occurs first: disease progression or loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent. Note: there is no fixed duration stopping rule for durvalumab in this biliary tract indication.
12. A formal medical review as to whether treatment with durvalumab in combination with gemcitabine and cisplatin should continue will occur at least by the end of the 2nd cycle of treatment.
13. Where a treatment break of more than 12 weeks beyond the expected 3 or 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
14. Durvalumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 09 April 2024

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA944 (10 January 2024)

Current Form Version

Note

The data on this page was produced using version 1.359 of the CDF list, downloaded from an archive of NHS England’s website on 11 April 2025 at 09:00.

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.