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Nivolumab and

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as RHUPH20

BRISTOL MYERS SQUIBB CO BMY CELG-RI · Clear Cell Renal Cell Carcinoma; Melanoma

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761381,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
BRISTOL MYERS SQUIBB CO BMY CELG-RI Source: Company record for BRISTOL MYERS SQUIBB CO (opens in a new tab)
Indications
Clear Cell Renal Cell Carcinoma; Melanoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Applications
BLA 761381 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761381 (opens in a new tab)
BLA 761234 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761234 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 21 May 20212 linked trials
  5. Filed Not yet
  6. Approved Not yetFirst approval 18 Mar 2022

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Nivolumab and. Editors add each one with its source.

Filed application

No filed application is on record for Nivolumab and. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Nivolumab and.

Clinical trials

Trials linked to Nivolumab and
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT05625399ClinicalTrials.gov record for NCT05625399 (opens in a new tab)RELATIVITY-127A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable MelanomaPhase 3Active, not recruiting579 (actual)4 Aug 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT05625399 (opens in a new tab)

Posted results on ClinicalTrials.gov for RELATIVITY-127

  • Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale (ug/mL)
    • Nivo + Rela FDC SC vs Nivo + Rela FDC IV: Adjusted Mean Difference 0.239 (90% CI 0.202 to 0.277), non-inferiority
  • Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale (ug/mL)
    • Nivo + Rela FDC SC vs Nivo + Rela FDC IV: Adjusted Mean Difference 0.398 (90% CI 0.356 to 0.440), non-inferiority
  • Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale (ug/mL)
    • Nivo + Rela FDC SC vs Nivo + Rela FDC IV: Adjusted Mean Difference 0.591 (90% CI 0.516 to 0.666), non-inferiority

Serious adverse events (All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).): Nivo + Rela FDC SC 143 of 283; Nivo + Rela FDC IV 140 of 291

More posted outcomes or analyses are on the study page. All posted results for NCT05625399

Source: ClinicalTrials.gov results for NCT05625399 (opens in a new tab)· imported

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.

NCT04810078ClinicalTrials.gov record for NCT04810078 (opens in a new tab)CheckMate-67TA Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has SpreadPhase 3Active, not recruiting681 (actual)29 Jul 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04810078 (opens in a new tab)

Posted results on ClinicalTrials.gov for CheckMate-67T

  • Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale (μg/mL)
    • Nivolumab SC vs Nivolumab IV: Adjusted Geometric Mean Ratio 2.098 (90% CI 2.001 to 2.200), non-inferiority
    • Nivo SC Process C vs Nivo SC Process D: Adjusted Geometric Mean Ratio 0.999 (90% CI 0.915 to 1.090), non-inferiority
  • Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale (μg/mL)
    • Nivolumab SC vs Nivolumab IV: Adjusted Geometric Mean Ratio 1.774 (90% CI 1.633 to 1.927), non-inferiority

Serious adverse events (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)): Nivolumab SC 109 of 247; Nivolumab IV 106 of 245; Nivo SC Process C 39 of 93; Nivo SC Process D 37 of 93

Source: ClinicalTrials.gov results for NCT04810078 (opens in a new tab)· imported

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.

Publications listing CheckMate-67T (1), newest first

  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.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Nivolumab and, newest first
ApplicationActionDateOutcomeReviewSource
BLA761381Action letter for BLA761381 (opens in a new tab) Supplement 5 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761381Action letter for BLA761381 (opens in a new tab) Supplement 1 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761381Action letter for BLA761381 (opens in a new tab) Supplement 2 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761381Action letter for BLA761381 (opens in a new tab) Original 1 Type 3 - New Dosage FormApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761234Action letter for BLA761234 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

Authorised

Opdivo (EMEA/H/C/003985)

Authorised
Therapeutic area
Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Carcinoma, Transitional Cell;Squamous Cell Carcinoma of Head and Neck;Urologic Neoplasms;Mesothelioma;Colorectal Neoplasms
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Active substance (INN)
nivolumab
ATC code
L01FF01
Latest EMA decision

Matched by active substance: EMA's INN or active substance equals this drug's name. EMA lists 1 other product with this substance, such as generics.

EMA page for Opdivo (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.