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.

emaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Melanoma	Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.	approved	Sep 15, 2022	ema
EU EMA	Lung Non-Small Cell Carcinoma	Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.	withdrawnsince Nov 30, 2015	Jul 20, 2015	ema
EU EMA	—	Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle …

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 17 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 101–150 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
NCT04339738	Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma	active not recruiting	Phase 2	90	National Cancer Institute (NCI)NIH	2	Sep 8, 2026	clinicaltrials
NCT05039073	Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors

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 20 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