{"entity":{"id":"javelin-merkel-200","kind":"trial","name":"JAVELIN Merkel 200","aka":[],"tldr":"JAVELIN Merkel 200 showed that the PD-L1 antibody avelumab shrinks about a third of Merkel cell carcinomas that have already failed chemotherapy, most of them durably, and it produced the first approved drug for this cancer.","summary":"JAVELIN Merkel 200 was a single-arm phase 2 trial of avelumab in metastatic Merkel cell carcinoma, a rare, aggressive neuroendocrine skin cancer driven either by Merkel cell polyomavirus or by ultraviolet mutation, both of which make it visible to the immune system. Part A enrolled patients whose disease had progressed after chemotherapy; part B enrolled untreated patients.\n\nIn part A the objective response rate was 31.8 percent in 88 patients (Lancet Oncology 2016), and responses were durable where chemotherapy responses had typically lasted only months. In part B, in 116 untreated patients, the response rate was 39.7 percent with long follow-up.\n\nAvelumab received accelerated approval in March 2017, the first drug ever approved for Merkel cell carcinoma, and with KEYNOTE-017 (pembrolizumab) it made PD-1 pathway blockade the first-line standard for advanced disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02155647","url":"https://clinicaltrials.gov/study/NCT02155647"},{"label":"Lancet Oncology 2016","url":"https://doi.org/10.1016/S1470-2045(16)30364-3"}],"tags":[],"related":[],"cancers":["merkel-cell-carcinoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["avelumab"],"companies":["pfizer"],"institutions":[],"pathways":["oncogenic-viruses"],"terms":[],"trials":[],"people":["howard-kaufman"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02155647","phase":"2","setting":"Metastatic Merkel cell carcinoma: avelumab after chemotherapy (part A) and as first-line treatment (part B)","sponsor":"EMD Serono / Pfizer","result":"Objective response 31.8% after chemotherapy (part A) and 39.7% first line (part B).","yearReported":2016,"enrolled":204,"outcomes":[{"endpoint":"Objective response rate (part A, after chemotherapy)","primary":true,"unit":"%","arms":[{"name":"Avelumab","n":88,"value":31.8}],"source":"https://doi.org/10.1016/S1470-2045(16)30364-3"},{"endpoint":"Objective response rate (part B, first line)","unit":"%","arms":[{"name":"Avelumab","n":116,"value":39.7}],"source":"https://doi.org/10.1136/jitc-2021-002646"}],"replication":"KEYNOTE-017 (pembrolizumab) and the retifanlimab POD1UM-201 study found the same order of response for PD-1 blockade in Merkel cell carcinoma."},"route":"/trials/javelin-merkel-200/","neighbours":{"cancer":[{"id":"merkel-cell-carcinoma","kind":"cancer","name":"Merkel cell carcinoma","route":"/cancers/merkel-cell-carcinoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"avelumab","kind":"drug","name":"Avelumab","route":"/drugs/avelumab/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"pathway":[{"id":"oncogenic-viruses","kind":"pathway","name":"Oncogenic viruses","route":"/pathways/oncogenic-viruses/"}],"person":[{"id":"howard-kaufman","kind":"person","name":"Howard L. Kaufman","route":"/people/howard-kaufman/"}]}}