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NCT04810078 · ClinicalTrials.gov registry record · Phase 3

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

A Phase 3 study of Clear Cell Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
681
Enrollment target
20
Study locations

NCT04810078 is a Phase 3 study of Clear Cell Renal Cell Carcinoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 681 participants, above the 188-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (262% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04810078, a Phase 3 study of Clear Cell Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
681 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Conditions Studied

Clear Cell Renal Cell Carcinoma

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Nivolumab and rHuPH20

Study Locations (20)

Other

  • Local Institution - 0038 - Buenos Aires
  • Local Institution - 0056 - San Juan
  • Local Institution - 0090 - Rio de Janeiro
  • Local Institution - 0081 - São Paulo
  • Local Institution - 0096 - São Paulo

Buenos Aires

  • Local Institution - 0095 - Capital Federal
  • Local Institution - 0058 - Mar del Plata
  • Local Institution - 0037 - Pergamino

Córdoba Province

  • Local Institution - 0079 - Parana
  • Local Institution - 0030 - Río Cuarto

Rio Grande do Sul

  • Local Institution - 0107 - Ijuí
  • Local Institution - 0039 - Porto Alegre

São Paulo

  • Local Institution - 0071 - Barretos
  • Local Institution - 0070 - São José do Rio Preto

Illinois

  • Local Institution - Chicago

New York

  • Local Institution - 0025 - Buffalo

Pennsylvania

  • Local Institution - 0088 - West Reading

Trial Details

FieldValue
Enrollment Target 681 participants
Start Date 2021-05-21
Est. Completion 2027-05-10
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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What the Registry Record Tells You About NCT04810078

The ClinicalTrials.gov registry entry for NCT04810078 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 681 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 188-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (262% 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 Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT04810078 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Buenos Aires, Córdoba Province.

Frequently Asked Questions

What is clinical trial NCT04810078 about?

NCT04810078 is a clinical study titled "A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread". The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evalu...

What is the current status of trial NCT04810078?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 681 participants. The study started on 2021-05-21. Estimated completion is 2027-05-10.

What conditions does trial NCT04810078 study?

This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma.

What interventions are being tested in trial NCT04810078?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Nivolumab and rHuPH20 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04810078?

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

Where is trial NCT04810078 being conducted?

This trial has 20 study locations across Illinois, New York, Pennsylvania, Buenos Aires, Córdoba Province. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.