A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Condition(s) studied
Investigational drug(s) / intervention(s)
Nivolumab and rHuPH20: Specified dose on specified days
Nivolumab: Specified dose on specified days
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.
Eligibility
Primary outcome measure(s)
- Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale — Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration. - Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale — Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration.
Trial sites (89)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution | Chicago | Illinois | |
| Local Institution - 0025 | Buffalo | New York | |
| Local Institution - 0088 | West Reading | Pennsylvania | |
| Local Institution - 0038 | Buenos Aires | Buenos Aires | |
| Local Institution - 0095 | Capital Federal | Buenos Aires | |
| Local Institution - 0058 | Mar del Plata | Buenos Aires | |
| Local Institution - 0037 | Pergamino | Buenos Aires | |
| Local Institution - 0079 | Parana | Córdoba Province | |
| Local Institution - 0030 | Río Cuarto | Córdoba Province | |
| Local Institution - 0066 | Viedma | Río Negro Province | |
| Local Institution - 0056 | San Juan | San Juan Province | |
| Local Institution - 0064 | Curitiba | Paraná | |
| Local Institution - 0090 | Rio de Janeiro | Rio de Janeiro | |
| Local Institution - 0107 | Ijuí | Rio Grande do Sul | |
| Local Institution - 0039 | Porto Alegre | Rio Grande do Sul | |
| Local Institution - 0071 | Barretos | São Paulo | |
| Local Institution - 0070 | São José do Rio Preto | São Paulo | |
| Local Institution - 0081 | São Paulo | São Paulo | |
| Local Institution - 0096 | São Paulo | São Paulo | |
| Local Institution - 0084 | Temuco | Araucania | |
| Local Institution - 0005 | Santiago | Santiago Metropolitan | |
| Local Institution - 0104 | Santiago | Santiago Metropolitan | |
| Local Institution - 0076 | Santiago | Santiago Metropolitan | |
| Local Institution - 0077 | Viña del Mar | Valparaiso | |
| Local Institution - 0063 | Brno | Czechia | |
| Local Institution - 0036 | Hradec Králové | Czechia | |
| Local Institution - 0020 | Olomouc | Czechia | |
| Local Institution - 0099 | Ostrava | Czechia | |
| Local Institution - 0010 | Prague | Czechia | |
| Local Institution - 0106 | Praha 8 Liben | Czechia | |
| Local Institution - 0017 | Tampere | Finland | |
| Local Institution | Nice | France | |
| Local Institution - 0051 | Suresnes | France | |
| Local Institution - 0068 | Villejuif | France | |
| Local Institution - 0060 | Tallaght | Dublin | |
| Local Institution - 0033 | Cremona | Italy | |
| Local Institution - 0008 | Florence | Italy | |
| Local Institution - 0027 | Meldola | Italy | |
| Local Institution - 0018 | Milan | Italy | |
| Local Institution | Milan | Italy |
+ 49 more sites — see the full list on the official registry below.
On this site
📄 Opdivo (nivolumab) drug profile →More Bristol-Myers Squibb trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04810078 on ClinicalTrials.gov ↗ ← All trials in Italy