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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 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.

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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

Melanoma

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

FieldValue
Enrollment Target 261 participants
Start Date 2019-06-24
Est. Completion 2023-11-06
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03980314

The ClinicalTrials.gov registry entry for NCT03980314 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 261 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (63% lower). 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 1 intervention - of which Nivolumab is the first listed.

NCT03980314 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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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.