🏛️ Verified NIH Record • Updated 2025-10-08

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)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Local Institution — Chicago, Illinois

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (89 Sites)

Showing the first 25 of 89 sites.

  • Local Institution — Chicago, Illinois
  • Local Institution - 0025 — Buffalo, New York
  • Local Institution - 0088 — West Reading, Pennsylvania
  • 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 - 0038 — Buenos Aires,
  • Local Institution - 0056 — San Juan,
  • Local Institution - 0064 — Curitiba, Paraná
  • 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 - 0090 — Rio de Janeiro,
  • Local Institution - 0081 — São Paulo,
  • Local Institution - 0096 — 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,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗