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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 · CheckMate-67T Phase 3Active, not recruiting

Lead sponsor
Bristol-Myers Squibb (Industry)
Enrollment
681 (actual)
Start date
21 May 2021
Primary completion
29 Jul 2025 (actual)
Study completion
10 May 2027
Last update posted
22 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
4

Interventions

  • Nivolumab and rHuPH20 Biological
  • Nivolumab Biological

Conditions and primary outcome

  • Clear Cell Renal Cell Carcinoma

Primary outcome

Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale (Pre-dose (Day 1 to Day 28)); Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale (Pre-dose (Day 1 to Day 28))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04810078 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Geometric mean
    Unit
    μg/mL

    • Nivolumab SC vs Nivolumab IVNon-inferiority

      Estimate
      2.098Adjusted Geometric Mean Ratio
      90% CI, two-sided
      2.001 to 2.200
      p-value
      Not given
      Method
      Not given

    • Nivo SC Process C vs Nivo SC Process DNon-inferiority

      Estimate
      0.999Adjusted Geometric Mean Ratio
      90% CI, two-sided
      0.915 to 1.090
      p-value
      Not given
      Method
      Not given

  2. Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Geometric mean
    Unit
    μg/mL

    • Nivolumab SC vs Nivolumab IVNon-inferiority

      Estimate
      1.774Adjusted Geometric Mean Ratio
      90% CI, two-sided
      1.633 to 1.927
      p-value
      Not given
      Method
      Not given

Serious adverse events

Time frame: All cause mortality was collected from randomization till last clinical data cut off (up to approximately 55 months). SAEs and AEs were collected from first dose (Day 1) untill 100 days after last dose (up to approximately 27 months)

Participants with serious adverse events per group for CheckMate-67T, as posted
GroupAffectedAt risk
Nivolumab SC109247
Nivolumab IV106245
Nivo SC Process C3993
Nivo SC Process D3793

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed

  1. Subcutaneous versus intravenous nivolumab for renal cell carcinoma.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2025 Jan

    PubMed 39288844 (opens in a new tab)DOI 10.1016/j.annonc.2024.09.002 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.