CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 783 enrolled
Drug / intervention
NKTR-214 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03635983
NCT03635983Phase 3Completed

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Bristol-Myers Squibb·interventional·Posted Aug 17, 2018·Updated Apr 1, 2025

In Brief

A Phase 3 clinical trial evaluating NKTR-214 and Nivolumab for Melanoma. Completed, enrolled 783 participants across 167 sites in 27 countries.

Detailed Summary

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, 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
CollaboratorsNektar Therapeutics

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartSep 21, 2018
Primary CompletionNov 19, 2021
Study CompletionMar 19, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.9 years ago

Interventions

NKTR-214biological

Specified dose on specified days

Nivolumabbiological

Specified dose on specified days