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NCT03635983 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
783
Enrollment target
20
Study locations

NCT03635983 is a Phase 3 study of Melanoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 783 participants, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT03635983, a Phase 3 study of Melanoma, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
783 participants
Enrollment target
20
Study locations

Study 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

Conditions Studied

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL NKTR-214

Study Locations (20)

Florida

  • Local Institution - 0153 - Miami
  • Local Institution - 0017 - Miami Beach
  • Local Institution - 0112 - Tampa

California

  • Local Institution - 0014 - La Jolla
  • Local Institution - 0122 - Stanford

New Jersey

  • Local Institution - 0016 - Hackensack
  • Local Institution - 0185 - New Brunswick

Oregon

  • Local Institution - 0011 - Portland
  • Local Institution - 0013 - Portland

Arizona

  • Local Institution - 0187 - Tucson

Colorado

  • Local Institution - 0051 - Aurora

Connecticut

  • Local Institution - 0065 - New Haven

Georgia

  • Local Institution - 0012 - Atlanta

Trial Details

FieldValue
Enrollment Target 783 participants
Start Date 2018-09-21
Est. Completion 2024-03-19
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT03635983

The ClinicalTrials.gov registry entry for NCT03635983 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 783 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (11% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03635983 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, California, New Jersey.

Frequently Asked Questions

What is clinical trial NCT03635983 about?

NCT03635983 is a clinical study titled "A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma". 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 ...

What is the current status of trial NCT03635983?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 783 participants. The study started on 2018-09-21. Estimated completion is 2024-03-19.

What conditions does trial NCT03635983 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT03635983?

The interventions under investigation include: Nivolumab (BIOLOGICAL), NKTR-214 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03635983?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03635983 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.