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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04810078
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 21, 2021
Status verified
Oct 2025
Primary completion
Jul 29, 2025
Completion
May 10, 2027

Study Design

Enrollment
681 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B
  • Experimental: Arm C
  • Experimental: Arm D

Primary Outcome Measure

Time-averaged serum concentration over 28 days (Cavgd28) [ Time Frame: Up to 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local InstitutionChicagoIllinois60611-
Local Institution - 0025BuffaloNew York14263-
Local Institution - 0088West ReadingPennsylvania19611-

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Local Institution· Chicago, ILLocal Institution - 0025· Buffalo, NYLocal Institution - 0088· West Reading, PA

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