{"entity":{"id":"nct03635983","kind":"trial","name":"A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma","aka":[],"tldr":"A phase 3 trial of Bempegaldesleukin and Nivolumab in Melanoma, run by Bristol-Myers Squibb, completed.","summary":"A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma is a phase 3 interventional study registered as NCT03635983 by Bristol-Myers Squibb, with 783 participants recorded, started 2018-09-21 and reaching its primary completion in 2021-11-19. Interventions recorded: NKTR-214, Nivolumab. Conditions recorded: Melanoma.\n\nLinked to the drug Bempegaldesleukin because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03635983","url":"https://clinicaltrials.gov/study/NCT03635983"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bempegaldesleukin","nivolumab"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03635983","phase":"3","setting":"A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma","sponsor":"Bristol-Myers Squibb","participation":[{"nct":"NCT03635983","source":"https://clinicaltrials.gov/study/NCT03635983","fetchedAt":"2026-10-07T16:53:05.987Z","studySha256":"7f37f2521fcc4c15c80d7b380adbce638d565003045e372114ea95513b3c5822","overallStatus":"COMPLETED","lastUpdatePosted":"2025-04-01","leadSponsor":"Bristol-Myers Squibb","collaboratorCount":1,"minimumAge":"12 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":783,"enrolmentType":"ACTUAL","siteCount":167,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","Chile","Czechia","Finland","France","Germany","Greece","Ireland","Israel","Italy","Mexico","Netherlands","New Zealand","Poland","Portugal","Romania","Russia","Spain","Sweden","Switzerland","United Kingdom","United States"]}],"started":"2018-09-21","startedType":"actual","yearReported":2022,"enrolled":783,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":271,"value":27.7,"note":"95% CI 22.4 to 33.4; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":272,"value":36,"note":"95% CI 30.3 to 42.0"}],"p":"0.0311","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"},{"endpoint":"Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":391,"value":4.17,"note":"95% CI 3.52 to 5.55; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":392,"value":4.99,"note":"95% CI 4.14 to 7.82"}],"hr":1.09,"ci":[0.89,1.33],"p":"0.3988","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Bempegaldesleukin + Nivolumab","n":391,"value":29.67,"note":"95% CI 22.14 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication"},{"name":"Nivolumab","n":392,"value":28.88,"note":"95% CI 21.32 to NA"}],"hr":0.94,"ci":[0.72,1.22],"p":"0.6361","source":"https://clinicaltrials.gov/study/NCT03635983?tab=results"}]},"route":"/trials/nct03635983/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"bempegaldesleukin","kind":"drug","name":"Bempegaldesleukin","route":"/drugs/bempegaldesleukin/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"target":[{"id":"nktr","kind":"target","name":"NKTR","route":"/targets/nktr/"}]}}