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

ClinicalTrials.gov ID: NCT04810078

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Official title

A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04810078
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 681 participants

Conditions and interventions

Conditions

Clear Cell Renal Cell Carcinoma

Interventions

Nivolumab and rHuPH20 Biological
Nivolumab Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2021 (Actual)
Primary completion: Jul 29, 2025 (Actual)
Completion: May 10, 2027 (Estimated)
Last update posted: Sep 22, 2026

2021 – 2027

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Local Institution	Chicago	Illinois	60611	—
Local Institution - 0025	Buffalo	New York	14263	—
Local Institution - 0088	West Reading	Pennsylvania	19611	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04810078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 22, 2026 · Synced Nov 14, 2026