Pembrolizumab in combination with chemotherapy with or without bevacizumab [PEMB22]
For the treatment of persistent, recurrent or metastatic cervical cancer in patients whose tumour PD-L1 expression test results have a combined positive score (CPS) of 1 or more where the following criteria have been met:
- This application is being made by and the first cycle of systemic anti-cancer therapy with pembrolizumab in combination with chemotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- 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.
- The patient has a histologically- or cytologically confirmed diagnosis of cervical carcinoma. Please mark below which histology applies to this patient:
- squamous carcinoma
- adeno-squamous carcinoma
- adenocarcinoma
- The patient’s tumour has been tested by an approved and validated test for PD-L1 expression as measured by the combined positive score (CPS) test and the result is 1 or more. Please document the actual CPS test result for PD-L1 expression below: PD-L1 expression with the CPS test: _______ Note: patients with tumours with a CPS test result of <1 or who have not had a CPS test are not eligible for treatment with pembrolizumab.
- The current disease status as to whether the patient has persistent locoregional disease with or without distant metastases or recurrent locoregional disease with or without distant metastases or has presented with distant metastatic spread. Please mark below which scenario applies to this patient:
- persistent locoregional disease without distant metastatic spread
- persistent locoregional disease with distant metastatic spread
- recurrent locoregional disease without distant metastatic spread
- recurrent locoregional disease with distant metastatic spread
- first presentation with distant metastatic spread
- The patient’s disease is currently not amenable to curative treatment (such as with surgery or radiotherapy or chemoradiotherapy).
- The type of treatment previously received by this patient for the cervical cancer: Please mark below the type of treatment received by this patient:
- chemoradiotherapy and surgery
- radiotherapy and surgery
- chemoradiotherapy only
- neoadjuvant chemotherapy followed by chemoradiotherapy
- radiotherapy only
- surgery only
- none
- I confirm that the patient has either not been previously treated with any systemic chemotherapy or has only received chemotherapy whether specifically used as a radio-sensitising agent or received neoadjuvant chemotherapy prior to chemoradiotherapy.
- The cytotoxic chemotherapy partner with the pembrolizumab is a combination chemotherapy with either paclitaxel plus cisplatin or paclitaxel plus carboplatin (AUC 5mg/mL/min). Note: a maximum of 6 cycles of cytotoxic chemotherapy is to be administered.
- Whether or not bevacizumab is also to be given in combination with chemotherapy and pembrolizumab: Please mark below whether bevacizumab is also to be given:
- yes, bevacizumab is also being given
- no, bevacizumab is not being administered Note: bevacizumab can be continued in combination with pembrolizumab beyond completion of chemotherapy if the patient is benefiting from treatment. Note: if after completing the course of pembrolizumab (see criterion 13) and the patient is still benefitting from treatment, the patient and the clinician have the option to continue with the bevacizumab as monotherapy until disease progression. Note: if bevacizumab is to be given with pembrolizumab and chemotherapy, there is no need to complete a separate blueteq form for the use of bevacizumab in cervical cancer.
- 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 received pembrolizumab via the MSD company early access scheme and all other treatment criteria on this form are fulfilled.
- The patient will be treated with a fixed dose of pembrolizumab of either 200mg every 3 weeks or 400mg every 6 weeks. Note: Pembrolizumab should be continued (with or without bevacizumab) in benefitting patients once chemotherapy has been completed.
- Treatment with pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or after 2 years of treatment (or after 35 x 3-weekly cycles or its equivalent if 6-weekly pembrolizumab is used).
- The patient has an ECOG performance status (PS) of 0 or 1.
- The patient has no symptomatically active brain metastases or leptomeningeal metastases.
- A formal medical review as to how pembrolizumab and chemotherapy with or without bevacizumab 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.
- Where a treatment break of more than 12 weeks beyond the expected 3 or 6 weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
- Pembrolizumab, paclitaxel, cisplatin/carboplatin and bevacizumab will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).
NHS funded From: 12 March 2024
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
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.