Drug · Monoclonal Antibody

Ipilimumab

CI-DRUG-00000309Explore in graph →NCIt C2654 CHEMBL1789844 CIViC Approved

Regulatory

Approvals (30)

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

openfdaRegulatory28 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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 FDA	—	Efficacy supplement 2025-01-28 (see label)	approved	Jan 28, 2025	openfda
US FDA	—	Efficacy supplement 2023-02-15 (see label)

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 2 days 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	200	78	63	667	30	CA, EU, US	Mar 25, 2011	2001-10
Malignant Kidney Neoplasm	Approved	Phase 4	35	20	8	60	1	US	Mar 25, 2011	2003-02
Malignant Lung Neoplasm	Approved	Phase 3	24	7	13	78	2	US	Mar 25, 2011	2002-03
Cutaneous Melanoma	Approved	Phase 3	11	3	3	25	1

Curated evidence

Clinical evidence (8)

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

civicCuratedShowing 1–8 of 8 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
High2
Ipilimumab + Lenvatinib

Clinical trials

Trials with this intervention (681)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 681 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
NCT05112601	Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma	recruiting	Phase 2	81	National Cancer Institute (NCI)NIH	1	Sep 28, 2026	clinicaltrials
NCT07227012	Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Cytotoxic T-lymphocyte protein 4 inhibitor
Targets: 1 gene
UNII: 6T8C155666
Aliases: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016, Ipilimumab, Ipilimumab Biosimilar CS1002, MDX 010, MDX-010, MDX010, MDX-010 MDX-CTLA4, MDX-101, MDX-CTLA-4, MDX-CTLA4, Yervoy, YERVOY

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

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

System	Code	Label
ATC (WHO)	L01FX04	IPILIMUMAB
DIN (Health Canada)	02379384	YERVOY
DPD drug code

MDM2 Amplification1

Ipilimumab + Nivolumab + PembrolizumabSubstitutes

Malignant NeoplasmALIAS

Predictive

Supports Adverse Response

submitted

EID2916

A study to investigate potential genomic markers associated with "hyper-progression" in patients treated with PD1/PD-L1 inhibition. Amongt 155 patients, TTF (time to treatment failure) <2 months was s… (full text at CIViC)

PMID 28351930 · Kato et al., 2017 · Open in CIViC

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CD274 Expression1

Ipilimumab + NivolumabCombination

Melanoma

Predictive

Does Not Support Sensitivity Response

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

Predictive

Supports Resistance

accepted

EID12142

C57BL/6 mice were inoculated with B16/BL6 tumour cells and treated with anti-CTLA-4 to assess in-vivo effects of IFNGR1 knockdown on tumour growth. All untreated mice with wildtype scramble shRNA-tran… (full text at CIViC)

PMID 27667683 · Gao et al., 2016 · Open in CIViC

Predictive

Supports Sensitivity Response

submitted

EID7333

The researchers quantified ctDNA in time-intervals during the treatment of 6 patients with stage IV melanoma. The patient carrying the NRAS Q61H mutation was started on ipilimumab and responded well. … (full text at CIViC)

PMID 26095797 · Tsao et al., 2015 · Open in CIViC

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PBRM1 Loss-of-function1

Ipilimumab

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID7301

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 6… (full text at CIViC)

PMID 29301960 · Miao et al., 2018 · Open in CIViC

civic

CD28 Fusion1

Ipilimumab

Sezary SyndromeALIAS

Predictive

Supports Sensitivity Response

accepted

EID1520

A 67-year-old Caucasian female with stage IVA Sezary syndrome presented refractory to traditional therapy and was enrolled in a whole genome study trial. Sequencing revealed a CTLA4-CD28 fusion protei… (full text at CIViC)

PMID 25802883 · Sekulic et al., 2015 · Open in CIViC

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