OncRef

Clinical Trial: NCT04810078

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Bristol-Myers Squibb
Information Provided By:Bristol-Myers Squibb
Last Update Posted:2026-09-22

Study Overview

Brief 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.

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

Conditions

Clear Cell Renal Cell Carcinoma

Intervention / Treatment

  • Biological: Nivolumab and rHuPH20
  • Biological: Nivolumab

Other Study ID Numbers

  • CA209-67T
  • 2020-003655-15
  • U1111-1255-9514

Start Date (Actual)

2021-05-21

Primary Completion Date (Actual)

2025-07-29

Study Completion Date (Estimated)

2027-05-10

Enrollment (Actual)

681

Study Type

Interventional

Phase

Phase 3