Trials / Active Not Recruiting
Active Not RecruitingNCT04810078
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, 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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 681 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab and rHuPH20 | Specified dose on specified days |
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2025-07-29
- Completion
- 2027-05-10
- First posted
- 2021-03-22
- Last updated
- 2025-10-09
Locations
89 sites across 17 countries: United States, Argentina, Brazil, Chile, Czechia, Finland, France, Ireland, Italy, Mexico, New Zealand, Poland, Portugal, Romania, Russia, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04810078. Inclusion in this directory is not an endorsement.