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NCT03980314 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
A Phase 1 study of Melanoma, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT03980314: Completed Phase 1 study of Melanoma, sponsored by Bristol-Myers Squibb.
NCT03980314 is a Phase 1 study of Melanoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 261 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03980314, a Phase 1 study of Melanoma, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 261 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
Conditions Studied
Interventions
- DRUG Nivolumab
Study Locations (20)
Other
- Local Institution - 0046 - Buenos Aires
- Local Institution - 0041 - Rio de Janeiro
- Local Institution - 0013 - Edmonton
- Local Institution - 0022 - Santiago
- Local Institution - 0009 - Marseille
- Local Institution - 0010 - Nantes
- Local Institution - 0011 - Paris
São Paulo
- Local Institution - 0039 - Barretos
- Local Institution - 0038 - Cerqueira César
- Local Institution - 0040 - São José do Rio Preto
Santiago Metropolitan
- Local Institution - 0024 - Independencia
- Local Institution - 0045 - Santiago
- Local Institution - 0023 - Santiago
Rio Grande do Sul
- Local Institution - 0036 - Ijuí
- Local Institution - 0037 - Porto Alegre
Connecticut
- Local Institution - 0006 - Hartford
Minnesota
- Local Institution - 0008 - Minneapolis
North Carolina
- Local Institution - 0035 - Charlotte
Pennsylvania
- Local Institution - 0043 - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 1 |
What the finished NCT03980314 record still lists
NCT03980314 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT03980314 names 20 study sites across 9 states, led by Other, São Paulo, Santiago Metropolitan.
Frequently Asked Questions
What is clinical trial NCT03980314 about?
NCT03980314 is a clinical study titled "A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection". The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
What is the current status of trial NCT03980314?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 261 participants. The study started on 2019-06-24. Estimated completion is 2023-11-06.
What conditions does trial NCT03980314 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT03980314?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03980314?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03980314 being conducted?
This trial has 20 study locations across Connecticut, Minnesota, North Carolina, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03980314's enrollment target sits among peer trials
261 58th of 266 higher than 209 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.
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