{"entity":{"id":"cemiplimab-kidney-transplant-cscc","kind":"trial","name":"Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma","aka":["cemiplimab in kidney transplant recipients"],"tldr":"Transplant patients are kept out of immunotherapy trials because the drugs can make the body reject the transplanted organ. This small study changed the anti-rejection drugs first, then gave the immunotherapy, and no one lost their kidney while nearly half saw their cancer shrink.","summary":"Solid organ transplant recipients carry the highest risk of cutaneous squamous cell carcinoma of any group, and the drug that works for advanced disease is the one they are excluded from receiving, because PD-1 blockade can trigger rejection of the graft. That exclusion is not a footnote: it means the group with the worst disease has no evidence at all.\n\nThis phase 1 study at Dana-Farber built a protocol around the problem. Immunosuppression was cross-tapered to a mammalian target of rapamycin inhibitor, and prednisone was pulsed around each cycle at 40 mg daily from the day before through day 3, 20 mg on days 4 to 6 and 10 mg until the day before the next cycle. Cemiplimab 350 mg was then given every three weeks for up to two years.\n\nTwelve patients were treated. No kidney rejection and no graft loss occurred, which was the primary endpoint. A response was seen in five of eleven evaluable patients (46 per cent, 90 per cent confidence interval 22 to 73), two of them lasting beyond a year. Median follow-up was 6.8 months, with a range of 0.7 to 29.8.\n\nThe risks were not only immunological. Treatment-related grade 3 or higher adverse events occurred in five patients (42 per cent), including diarrhoea, infection and metabolic disturbance, and one patient died of angioedema and anaphylaxis attributed to the mammalian target of rapamycin inhibitor cross-taper, not to the cemiplimab. Twelve patients is twelve patients. But it is the first prospective evidence that the combination can be given, and the regimen it describes is what a transplant nephrologist and an oncologist can now discuss instead of refusing treatment outright.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT04339062","url":"https://clinicaltrials.gov/study/NCT04339062"},{"label":"Primary report (Journal of Clinical Oncology 2024)","url":"https://doi.org/10.1200/JCO.23.01498"},{"label":"Primary report on PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/38252908/"}],"tags":[],"related":[],"cancers":["cutaneous-scc","advanced-cutaneous-scc","skin-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":["dana-farber"],"pathways":[],"terms":["skin-cancer-after-organ-transplant","irae"],"trials":["tumorapa","empower-cscc-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04339062","phase":"1/2","setting":"Kidney transplant recipients with advanced cutaneous squamous cell carcinoma: cross-taper of immunosuppression to a mammalian target of rapamycin inhibitor with pulsed corticosteroids around each cycle, then cemiplimab 350 mg every three weeks for up to two years, with the rate of kidney rejection as the primary endpoint","sponsor":"Dana-Farber Cancer Institute, funded by Regeneron Pharmaceuticals","result":"No kidney rejection or graft loss in 12 kidney transplant recipients given cemiplimab after cross-taper to a mammalian target of rapamycin inhibitor with pulsed corticosteroids, with responses in 5 of 11 evaluable patients (46 per cent, 90 per cent confidence interval 22 to 73).","yearReported":2024,"enrolled":12,"enrolledBasis":"registry","outcomes":[{"endpoint":"Kidney rejection or graft loss","primary":true,"unit":"events","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":12,"value":0}],"source":"https://doi.org/10.1200/jco.23.01498"},{"endpoint":"Objective response","unit":"%","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":11,"value":46,"note":"5 of 11 evaluable patients; 90 per cent confidence interval 22 to 73; 2 responses beyond a year"}],"source":"https://doi.org/10.1200/jco.23.01498"},{"endpoint":"Treatment-related grade 3 or higher adverse events","unit":"%","arms":[{"name":"Cemiplimab with mammalian target of rapamycin inhibitor and pulsed prednisone","n":12,"value":42,"note":"5 of 12 patients; one death from angioedema and anaphylaxis attributed to the cross-taper"}],"source":"https://doi.org/10.1200/jco.23.01498"}],"replication":"Case series support it without settling it: a Belgian cohort of seven kidney transplant recipients given cemiplimab reported an overall response rate of 42.8 per cent with biopsy-proven acute rejection in one patient, who lost graft function but had a complete tumour response."},"route":"/trials/cemiplimab-kidney-transplant-cscc/","neighbours":{"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"}],"company":[{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"}],"institution":[{"id":"dana-farber","kind":"institution","name":"Dana-Farber Brigham Cancer Center","route":"/institutions/dana-farber/"}],"term":[{"id":"irae","kind":"term","name":"Immune-related adverse events (irAEs)","route":"/terms/irae/"},{"id":"skin-cancer-after-organ-transplant","kind":"term","name":"Skin cancer after an organ transplant","route":"/terms/skin-cancer-after-organ-transplant/"}],"trial":[{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","route":"/trials/empower-cscc-1/"},{"id":"tumorapa","kind":"trial","name":"TUMORAPA (switching from a calcineurin inhibitor to sirolimus after a transplant skin cancer)","route":"/trials/tumorapa/"}]}}