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East Midlands Cancer Drug Fund (EMCDF) Application for Ipilimumab the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy PATIENT PERSONAL DETAILS Patient Name: Date of Birth: NHS Number: Primary Care Trust: GP Name & Practice Details: Please note that all personal information will be removed prior to the consideration by the EMCDF panel DETAILS OF REQUESTER (include referring clinician contact details in the event of query or need for clarification) Name: Designation: Trust: Contact phone number: Secure email for correspondence: Provider Trust Chemotherapy Lead Yes No (or equivalent) Support: Name of Trust Chemotherapy Lead (or equivalent): CLINICAL DETAILS ECOG Performance status Unresectable/metastatic melanoma previously treated with systemic chemotherapy? 0 1 2 3 Yes No CONSENT I confirm that this Request has been discussed in full with the patient and that the patient is aware that they are consenting for the Cancer Drugs Fund Panel to access confidential clinical information held by clinical staff involved with their care about them as a patient to enable full consideration of this funding request Signature of Requester: Date: MONITORING RESPONSE How will the benefits of the procedure/treatment be measured? (incl. frequency of assessments) The efficacy of treatment will be monitored using standard imaging techniques (predominantly CT scanning). ~12 weekly scans. There are well defined criteria for monitoring immune related clinical responses (a modified RECIST) What ‘stopping’ criteria will be in place to decide when the treatment is ineffective? 1. Evidence of disease progression (modified RECIST) 2. Intolerable side effects Please note that regular updates on response to treatment will be requested by the Cancer Drugs Fund Panel and/or EMSCG E-mail completed application forms to [email protected] Document Code: EMCN-DC-0132-11 Written By: Colin Ward Date of Issue: 28 November 2011 Authorised By: Review Date: November 2012 Page Number: 1 of 1