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ACTIVE NOT RECRUITING 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

NCT04810078 · View on ClinicalTrials.gov ↗

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.

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

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04810078

The ClinicalTrials.gov registry entry for NCT04810078 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 681 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04810078 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Buenos Aires, Córdoba Province. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04810078?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Nivolumab and rHuPH20 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04810078?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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