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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: Completed Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
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
| Field | Value |
|---|---|
| Enrollment Target | 783 participants |
| Start Date | 2018-09-21 |
| Est. Completion | 2024-03-19 |
| Phase | Phase 3 |
What the finished NCT03635983 record still lists
NCT03635983 is an interventional study that assigns participants to a tested intervention. The registered 783 participants enrollment target is mid-sized for trials with a published cap, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (11% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03635983's enrollment target sits among peer trials
783 28th of 266 higher than 239 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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