OncologyDrug intelligence

Opdivo

Nivolumab

PD-1 immune checkpoint inhibitor. Developed by Bristol Myers Squibb. Clinical, regulatory, and source evidence are connected below.

Company: Bristol Myers Squibb
Target / MOA: PD-1 · PDCD1
Aliases: Opdivo · ONO-4538 · BMS-936558

Signals: 25
Clinical trials: 20
Approvals: 2
Evidence sources: 25

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialApr 3, 2026ClinicalTrials.gov

Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

Phase 1 · RECRUITING · Corcept Therapeutics

clinical trialApr 3, 2026ClinicalTrials.gov

Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Phase 2 · RECRUITING · Karie Runcie

clinical trialApr 3, 2026ClinicalTrials.gov

Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)

Phase 3 · ACTIVE_NOT_RECRUITING · National Cancer Institute (NCI)

Clinical trials

Key active studies

A focused view of recently updated studies · 20 linked records.

Phase 1RECRUITINGNCT07276373

Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

Corcept Therapeutics · Updated Apr 3, 2026

Phase 2RECRUITINGNCT06863311

Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Karie Runcie · Updated Apr 3, 2026

Phase 3ACTIVE NOT RECRUITINGNCT02595944

Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)

National Cancer Institute (NCI) · Updated Apr 3, 2026

Phase 2RECRUITINGNCT06064097

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

National Cancer Institute (NCI) · Updated Apr 3, 2026

Phase 2ACTIVE NOT RECRUITINGNCT04310007

Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer

National Cancer Institute (NCI) · Updated Apr 3, 2026

Phase 3ACTIVE NOT RECRUITINGNCT03233711

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

National Cancer Institute (NCI) · Updated Apr 3, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

Mar 18, 2026 · EMA Human Medicines

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 72, Status: Authorised

May 23, 2025 · FDA

OPDIVO QVANTIG

Feb 15, 2023 · FDA

OPDIVO

Related intelligence

Connected drugs

Records connected through the current intelligence graph.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Apr 3, 202620 FDAofficial · Latest May 23, 20252 EMA Human Medicinesofficial · Latest Mar 18, 20261

Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.