Durvalumab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel) [DUR5]

For the 1st line treatment of mismatch repair deficient (dMMR) or microsatellite instability-high endometrial carcinoma in adult patients who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy 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 carboplatin and paclitaxel 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 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis, myocarditis and skin toxicity.
3. The patient has a histologically- or cytologically confirmed diagnosis of endometrial carcinoma (including clear cell and serous histologies). Note: patients with carcinosarcoma (Mixed Mullerian tumour) are eligible but otherwise uterine sarcomas of any kind are NOT eligible for durvalumab in this indication.
4. The patient’s tumour has a documented presence of mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H) confirmed by validated testing.
5. The patient either has a 1st recurrence of endometrial carcinoma after surgery or radiotherapy or chemoradiotherapy or has presented with primary locally advanced or metastatic endometrial carcinoma and in whichever scenario is not a candidate for any potentially curative treatment with surgery or radiotherapy or chemoradiotherapy. Please mark below which scenario applies to this patient:

• 1st recurrence after previous surgery, radiotherapy or chemoradiotherapy or
• presented with primary stage IIIA disease and has received no systemic therapy or
• presented with primary stage IIIB disease and has received no systemic therapy or
• presented with primary stage IIIC1 disease and has received no systemic therapy or
• presented with primary stage IIIC2 disease and has received no systemic therapy or
• presented with primary stage IV disease and has received no systemic therapy

6. The patient either has not previously received any systemic chemotherapy for the endometrial carcinoma, or the only systemic therapy has been as neoadjuvant or adjuvant chemotherapy or chemoradiotherapy and the patient has progressed or recurred at least 6 months since the completion of such chemotherapy. Please mark below which scenario applies to this patient:

• the patient is treatment-naïve to chemotherapy for the endometrial cancer or
• the only systemic therapy has been as neoadjuvant or adjuvant chemotherapy or chemoradiotherapy and the patient has progressed or recurred at least 6 months since the completion of such chemotherapy

7. Durvalumab will be given in combination with carboplatin and paclitaxel unless there is a clear contraindication to the use of one or both of these cytotoxic agents. Please mark below which scenario applies to this patient:

• the intent is to use the combination of carboplatin and paclitaxel as the chemotherapy partner to durvalumab or
• the patient has a clear contraindication to the use of carboplatin and/or paclitaxel and hence an alternative platinum-based combination therapy has to be used as the chemotherapy partner to durvalumab Note: in patients who suffer a severe allergic reaction to paclitaxel or carboplatin which necessitates discontinuation of the drug causing the severe allergy, use of durvalumab can continue with carboplatin or paclitaxel in combination with whichever agent is considered appropriate by the clinician.

8. Unless the patient is contraindicated from starting with carboplatin and paclitaxel, the patient will commence combination chemotherapy with carboplatin at a dose of AUC 5mg/ml/min and paclitaxel at 175mg/m², planned to be given 3-weekly and for a maximum of 6 cycles of chemotherapy.
9. The patient has not received any prior antibody treatment 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 has already received durvalumab for the same indication via a company sponsored early access scheme Please mark below which scenario applies to this patient:

• the patient has not received any prior antibody treatment which targets PD-1 or PD-L1 or PD-L2 or CD137 or OX40 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4)
• the patient has received durvalumab for the same indication via a company sponsored early access scheme and meets all other criteria on this form

10. The patient will be treated with a fixed dose of durvalumab 1120mg every 3 weeks when in combination with chemotherapy and then at a dose of 1500mg every 4 weeks as monotherapy. Note: patients with a body weight of 30 kg or less during maintenance phase must receive weight-based dosing equivalent to durvalumab at 20 mg/kg
11. Treatment with durvalumab will be stopped at whichever of the following events occurs first: disease progression or loss of clinical benefit or unacceptable toxicity or withdrawal patient consent or after a maximum of 3 calendar years of treatment.
12. The patient has an ECOG performance status (PS) of 0 or 1. Note: NHS England does not fund this combination in patients of ECOG PS > 1
13. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
14. A formal medical review as to how durvalumab and carboplatin and paclitaxel are being tolerated, and whether treatment with this combination should continue or not, will be scheduled to occur at least by the end of the first 6 weeks of treatment.
15. When a treatment break of more than 12 weeks beyond the expected 3 or 4 weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
16. Durvalumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 26 March 2025

Additional information

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The data on this page was produced using version 1.356 of the CDF list, downloaded from an archive of NHS England’s website on 26 March 2025 at 14:00.

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.

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