CDEK
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nivolumab

Trade name: opdivo

mAbapprovedCOVID-19Orphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Dec 22, 2014

Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication in the class of immune checkpoint inhibitors. It selectively binds and blocks the programmed death-1 (PD-1) receptor on T cells, thereby facilitating their activation. It is used to treat certain types of cancer including melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer. It is administered intravenously. — Wikipedia

Clinical trial activity

1,593 trials · 696 clinical orgs · 1 marketing orgs

Phase 1
641
Phase 2
1179
Phase 3
175
Phase 4
14

Earliest trial started Aug 1, 2006 (NCT00441337)

Timeline

2000s

  1. Jan 1, 2006

    Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  3. Jan 23, 2013

    Orphan Drug Designation

  4. Dec 22, 2014

    Bristol-Myers Squibb — Earliest FDA Approval

  5. Dec 22, 2014

    Bristol-Myers Squibb — Marketing Organization

  6. Dec 22, 2014

    Bristol-Myers Squibb — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedAcceleratedFast trackBreakthroughDec 22, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • anti-pd-1 antibody
  • bms936558
  • bms-936558
  • bms-936558
  • bms-936558
  • bms-936558
  • humanized anti-pd-1 mab
  • mdx-1106
  • mdx-1106
  • mdx-1106
  • mdx-1106
  • mdx1106-02
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • nivolumab
  • ono-4538
  • ono-4538
  • ono-4538
  • ono-4538
  • opdivo
  • opdivo
  • opdivo
  • opdivo
  • opdivo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07187869Phase 1Mar 31, 2026Exelixis, University of Texas at Houston
NCT07293351Phase 1/Phase 2 (Phase 2)Mar 26, 2026Biontech, Bristol-Myers Squibb
NCT07221149Phase 2/Phase 3 (Phase 3)Mar 9, 2026Biontech, Bristol-Myers Squibb
NCT07219459Phase 2Feb 28, 2026CatalYm GmbH
NCT07216833Phase 1Jan 31, 2026Case Western Reserve University
NCT07210632Early Phase 1 (Phase 1)Jan 1, 2026Vanderbilt University
NCT06999980Phase 2Dec 31, 2025Bristol-Myers Squibb, Melanoma Institute Australia
NCT07276373Phase 1/Phase 2 (Phase 2)Dec 31, 2025Corcept Therapeutics
NCT07281924Phase 1/Phase 2 (Phase 2)Dec 31, 2025Delcath Systems, University of Wisconsin
NCT07176975Phase 1Dec 18, 2025Boehringer Ingelheim
NCT07196384Phase 1Dec 15, 2025University of Groningen
NCT07128680Phase 1Dec 5, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07195695Phase 3Dec 5, 2025Boehringer Ingelheim
NCT07230613Phase 2Dec 1, 2025UNICANCER
NCT07226856Phase 2Dec 1, 2025Mayo Clinic
NCT07075120Phase 1Dec 1, 2025University of Hawaii
NCT07233668N/ADec 1, 2025Seoul National University
NCT07213557Phase 2Nov 30, 2025Fondazione Giovanni Pascale
NCT06968988Phase 1Nov 30, 2025Exelixis, Washington University in St. Louis
NCT06963905Phase 1/Phase 2 (Phase 2)Nov 30, 2025Bristol-Myers Squibb, Yale University
Showing 20 of 1,593 trials
Page 1 / 80

Organizations

Research & Development (696)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit62720252006
National Cancer Institute (NCI)Government20710042010
Ono PharmaceuticalsFor profit742532009
University of Texas at HoustonAcademic/Hospital726532012
Harvard UniversityAcademic/Hospital504132013
Johns Hopkins UniversityAcademic/Hospital443932013
University of South FloridaAcademic/Hospital302722010
ExelixisFor profit25442017
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital232122017
Netherlands Cancer InstituteAcademic/Hospital222032015
University of PittsburghAcademic/Hospital211832014
Institut Gustave RoussyAcademic/Hospital191042016
Cornell UniversityAcademic/Hospital181232014
City of Hope National Medical CenterAcademic/Hospital171422017
ECOG-ACRIN Cancer Research GroupAcademic/Hospital17132014
University of CopenhagenAcademic/Hospital171622016
Emory UniversityAcademic/Hospital161622017
Washington University in St. LouisAcademic/Hospital161522015
Hoosier Cancer Research NetworkAcademic/Hospital141312017
Ohio State UniversityAcademic/Hospital141122016
696 organizations
Page 1 / 35

Marketing (3)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitMKTGDec 22, 2014
Bristol-Myers SquibbFor profitNDADec 22, 2014
Bristol-Myers SquibbFor profitSYNDec 27, 2024