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Completed Phase 3 Interventional Results available

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

ClinicalTrials.gov ID: NCT03635983

Public ClinicalTrials.gov record NCT03635983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 12:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03635983
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
783 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 21, 2018 (Actual)
Primary completion
Nov 19, 2021 (Actual)
Completion
Mar 19, 2024 (Actual)
Last update posted
Apr 1, 2025

2018 – 2024

United States locations

U.S. sites
24
U.S. states
18
U.S. cities
23
Facility City State ZIP Site status
Local Institution - 0187 Tucson Arizona 85724 —
Local Institution - 0014 La Jolla California 92093 —
Local Institution - 0122 Stanford California 94305 —
Local Institution - 0051 Aurora Colorado 80045 —
Local Institution - 0065 New Haven Connecticut 06510 —
Local Institution - 0153 Miami Florida 33136 —
Local Institution - 0017 Miami Beach Florida 33140 —
Local Institution - 0112 Tampa Florida 33612 —
Local Institution - 0012 Atlanta Georgia 30322-1013 —
Local Institution - 0019 Louisville Kentucky 40202 —
Local Institution - 0018 Boston Massachusetts 02215 —
Local Institution - 0188 Ann Arbor Michigan 48109 —
Local Institution - 0186 Fridley Minnesota 55432 —
Local Institution - 0135 St Louis Missouri 63110 —
Local Institution - 0016 Hackensack New Jersey 07601 —
Local Institution - 0185 New Brunswick New Jersey 08903 —
Local Institution - 0141 New York New York 10065 —
Local Institution - 0037 Cleveland Ohio 44195 —
Local Institution - 0011 Portland Oregon 97213 —
Local Institution - 0013 Portland Oregon 97239 —
St. Luke's Hospital & Health Network Easton Pennsylvania 18045 —
Local Institution - 0015 Philadelphia Pennsylvania 19111 —
Local Institution - 0001 Houston Texas 77030 —
Local Institution - 0064 Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 143 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03635983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 1, 2025 · Synced Oct 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03635983 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →