{"registry": "ISRCTN", "registryId": "ISRCTN10511385", "source": "https://www.isrctn.com/ISRCTN10511385", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN10511385/format/default", "fetchedAt": "2026-10-07T17:01:02.333698Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A trial of 3-weekly cemiplimab in patients with locally advanced basal cell carcinoma", "scientificTitle": "Efficacy and safety of first line Cemiplimab in advanced BCC: A phase 2 trial (IMPACT)", "acronym": "IMPACT", "hypothesis": "Primary objective: \nTo evaluate the benefit and safety of cemiplimab, a fully human anti-PD-1 monoclonal antibody in patients with locally advanced BCC\n\nSecondary objectives: \n1. Evaluate safety and tolerability including frequency, severity and relatedness of adverse events (AEs) to the study treatment.  AEs will be assessed according to CTCAE v5.0\n2. To assess ORR at various timepoints from trial treatment start\n3. To assess DCR (ORR plus stable disease) at various timepoints from trial treatment start\n4. To assess progression-free survival (PFS) defined as the time from registration to the first of one of the following: development of clinical/radiological disease progression (composite criteria/RECIST 1.1) or death from any cause.\n5. To assess overall survival (OS) defined as time from registration to the date of death from any cause\n6. To assess patient health status and quality of life (QoL) using the patient reported outcome measures.", "primaryOutcome": "To assess the objective response rate (ORR) of cemiplimab in patients with locally advanced BCC at 6 months, by independent central review.\nORR is defined as the proportion of patients having achieved partial or complete remission. This will be assessed for patients with only visible tumour(s), using the clinical response criteria according to World Health Organization (WHO) criteria and for patients who have target lesions measurable by both clinical response and radiologically by RECIST1.1, using the composite response criteria.", "secondaryOutcome": "1. ORR and DCR reported with 80% and 95% CI at 12m and 24m \n2. Progression free survival (PFS) measured from date of registration until progression or death respectively. Patients free from a progression event will be censored on the date of the last follow up visit.\n3. Overall survival measured from date of registration until progression or death respectively. Patients free from a progression event will be censored on the date of the last follow up visit.\n4. Toxicity- from day 1 of treatment until 95 days after last treatment\n5. Quality of Life using patient reported outcome measures EQ-5D-5L, EORTC QLQ-C30, SKINDEX-16, FNAE and Hornheide questionnaire measured at baseline and then every 12 weeks on treatment and then within 6 weeks of the final treatment date. Absolute means at each assessment point will be compared against baseline", "intervention": "\n\t1 arm (open label, no randomisation) - patients receive 350mg cemiplimab IV over 30 minutes on day 1 of a 21 day cycle. Patients can have up to 34 cycles or a maximum of 2 years of treatment. Patients will remain on treatment until disease progression or withdrawal from trial treatment for another reason. Once trial treatment has ended they will enter the follow up period for a further 2 years.\n\tDrug\n\tPhase II\n\tCemiplimab\n      ", "condition": "\n\tLocally advanced basal cell carcinoma (laBCC)\n\tCancer\n\t\n      ", "studyDesign": "Interventional non randomized", "overallEndDate": "2029-04-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2023-12-21T14:51:33.465168Z", "eligibility": {"inclusion": "1. Men and women age ≥ 18 years\n2. ECOG performance status 0 or 1\n3. Histologically confirmed disease (from diagnostic biopsy) that is considered to be inappropriate for surgery in the opinion of a SS-MDT\n4. Patients must be deemed as not appropriate for radiotherapy in the opinion of a SS-MDT\n5. There must be at least 1 measurable baseline lesion.\n6. Adequate hepatic, renal and bone marrow function\n7. Anticipated life expectancy >12 weeks", "exclusion": "1. Patients with metastatic BCC or Gorlins syndrome are excluded\n2. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs\n3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.\n4. Active infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV).\n5. History of pneumonitis within the last 5 years\n6. Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 28 days or 5 half-lives of the drug, whichever is shorter, prior to treatment start (Cycle 1 Day 1).\n7. Treatment with PI3K inhibitors\n8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).\n9. Any anticancer treatment within 30 days of the initial administration of cemiplimab or planned to occur during the study period other than palliative radiotherapy.\n10. Breastfeeding\n11. Positive serum pregnancy test.\n12. Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.\n13. Receipt of live vaccines (including attenuated) within 30 days of first study treatment.\n14. Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation.\n15. History of an additional malignancy within 5 years of registration with the exception of those malignancies with a negligible risk of metastasis or death and treated with curative intent.\n16. Other concurrent serious illness or medical condition that in the investigator’s opinion precludes entry into the trial.\n17. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.\n18. Prior treatment with other systemic immune-modulating agents within fewer than 28 days prior to the first dose of cemiplimab.", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2023-09-01T00:00:00.000Z", "recruitmentEnd": "2025-09-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "41", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England", "Wales"], "locations": [{"name": "Bristol Haematology & Oncology Centre", "city": "Bristol", "state": "", "country": "United Kingdom", "zip": "BS2 8ED"}, {"name": "Velindre Cancer Centre", "city": "Cardiff", "state": "", "country": "United Kingdom", "zip": "CF14 2TL"}, {"name": "Mount Vernon Hospital", "city": "Northwood", "state": "", "country": "United Kingdom", "zip": "HA6 2RN"}, {"name": "The Christie Hospital", "city": "Manchester", "state": "", "country": "United Kingdom", "zip": "M20 4BX"}, {"name": "Royal Cornwall Hospital", "city": "Truro", "state": "", "country": "United Kingdom", "zip": "TR1 3LJ"}, {"name": "Derriford Hospital", "city": "Plymouth", "state": "", "country": "United Kingdom", "zip": "PL6 8DH"}, {"name": "Norfolk and Norwich University Hospital", "city": "Norwich", "state": "", "country": "United Kingdom", "zip": "NR4 7UY"}, {"name": "St James's University Hospital", "city": "Leeds", "state": "", "country": "United Kingdom", "zip": "LS9 7TF"}, {"name": "Addenbrooke's Hospital", "city": "Cambridge", "state": "", "country": "United Kingdom", "zip": "CB2 0QQ"}, {"name": "St Bartholomew's Hospital", "city": "London", "state": "", "country": "United Kingdom", "zip": "EC1A 7BE"}], "sponsors": [{"organisation": "University Hospitals Bristol and Weston NHS Foundation Trust", "sponsorType": "Hospital/treatment centre"}], "funders": [{"name": "Sanofi via an ISS project grant"}]}, "studySha256": "83b641b6fb2373d94b223fc3d57582d6f626faaa1f6b4f737e341c102054e0e8"}