Drug · Monoclonal Antibody

Nivolumab

CI-DRUG-00000411Explore in graph →NCIt C68814 CHEMBL2108738 CIViC Approved

Regulatory

Approvals (98)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory50 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-03-20 (see label)	approved	Mar 20, 2026	openfda
US FDA	—	Efficacy supplement 2025-05-23 (see label)	approved	May 23, 2025	openfda
US FDA	—	Efficacy supplement 2025-04-11 (see label)	approved	Apr 11, 2025	openfda
US FDA	—	Efficacy supplement 2025-04-08 (see label)	approved	Apr 8, 2025	openfda
US

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	487	186	150	1,391	98	CA, EU, US	Dec 22, 2014	2006-08
Malignant Lung Neoplasm	Approved	Phase 4	73	29	32	218	6	EU, US	Dec 22, 2014	2006-08
Malignant Kidney Neoplasm	Approved	Phase 4	59	26	17	126	3	US	Dec 22, 2014	May 31, 2011
Hodgkin Lymphoma	Approved	Phase 3	28	8	3	54	2

Curated evidence

Clinical evidence (29)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–29 of 29 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TBXT Expression1
Nivolumab	Chordoma

Clinical trials

Trials with this intervention (1,426)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 1,426 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05048212	A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases	recruiting	Phase 2	20	M.D. Anderson Cancer CenterOTHER	1	Sep 18, 2026	clinicaltrials
NCT05267626	Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death protein 1 inhibitor
Targets: 1 gene
UNII: 31YO63LBSN
Aliases: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, BMS-986298, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, Nivolumab bms, Nivolumab component of bms-986213, Nivolumab component of opdualag, ONO 4538, ONO-4538, ONO4538, Opdivo, OPDIVO, OPDUALAG

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (16)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF01	NIVOLUMAB
ATC (WHO)	L01FY02	NIVOLUMAB AND RELATLIMAB

CD274 Expression8
Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID743 Based on a meta-analysis of 20 trials (1475 patients), PD-L1 expression was associated with a higher ORR rate in patients with NSCLC. Active drugs were Nivolumab and Pembrolizumab, PD-1 receptor targe… (full text at CIViC) PMID 26086854 · Carbognin et al., 2015 · Open in CIViC	civic
Atezolizumab + Avelumab + Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1167 Meta-Analysis of PD-L1 (CD274) Expression Status in 914 patients (7 studies) and response to PD-1/PD-L1 monoclonal antibodies. Patients with PD-L1 positive tumors (PD-L1 tumor cell staining ≥1%), had … (full text at CIViC) PMID 26918451 · Passiglia et al., 2016 · Open in CIViC	civic
Atezolizumab + Avelumab + Durvalumab + Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4857 In this meta-analysis of 14 studies with 2857 patients, the immunotherapy response rate was higher among PD-L1-positive patients (RR: 2.19, 95% CI: 1.63-2.94). PD-L1 expression was also related to bet… (full text at CIViC) PMID 28472902 · Aguiar et al., 2017 · Open in CIViC	civic
Nivolumab	Malignant Nasopharyngeal NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	1	submitted	EID9010 In a Clinic Phase 2 Consortium, 44 patients with metastatic nasopharyngeal carcinoma had an overall response rate (ORR) to nivolumab of 20.5%; 1 complete response lasting over 12 months; 8 partial res… (full text at CIViC) PMID 29584545 · Ma et al., 2018 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	2	accepted	EID1517 Trial NCT00730639 tested monoclonal antibody nivolumab against the PD-1 immune checkpoint receptor in pretreated patients with various cancer types. PD-L1 expression was tested in 42 patients by ICH f… (full text at CIViC) PMID 22658127 · Topalian et al., 2012 · Open in CIViC	civic
Ipilimumab + NivolumabCombination	Melanoma	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID1615 A clinical trial of 86 patients evaluated concurrent (n=53) or sequential (n=33) treatment of ipilimumab (anti-CTLA4) and nivolumab (anti-PD1). In the concurrent regimen cohort, 65% of patients showed… (full text at CIViC) PMID 23724867 · Wolchok et al., 2013 · Open in CIViC	civic
Nivolumab + PembrolizumabSubstitutes	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID704 Based on a meta-analysis of 20 trials (1475 patients), of which 7 studies (636 patients) included melanoma, PD-L1 expression was associated with a higher ORR rate in patients with melanoma. Active dru… (full text at CIViC) PMID 26086854 · Carbognin et al., 2015 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	1	submitted	EID9008 Within a preclinical trial, 37 patients with metastatic melanoma showed a limited number of cases that responded to anti-PD-1 antibodies in correlation to higher immunohistochemical PD-L1 expression. … (full text at CIViC) PMID 27491654 · Cho et al., 2016 · Open in CIViC	civic

PBRM1 Loss-of-function2
Nivolumab	Renal Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	submitted	EID7584 In post hoc analysis in phase 3 trial, which compared nivolumab and everolimus in patients with clear cell renal cell carcinoma who received prior antiangiogenic therapy, PBRM1 mutations were identifi… (full text at CIViC) PMID 31486842 · Braun et al., 2019 · Open in CIViC	civic
Nivolumab + PembrolizumabSubstitutes	Renal Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID7536 Among 35 patients with clear cell RCC, loss-of-function mutation of PBRM1 were correlated with response to anti-PD-1 monotherapy (P = 0.012). It was confirmed in an independent validation cohort of 63… (full text at CIViC) PMID 29301960 · Miao et al., 2018 · Open in CIViC	civic