DrugEvidence

Drugs / Ipilimumab

Ipilimumab

Drug

Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody marketed as Yervoy. It is used for melanoma and, often with nivolumab, for renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal carcinoma. The FDA first approved Yervoy in March 2011.

Trials
820
Recruiting
106
Completed
360
With results
275

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownNo longer availableTotal
Early Phase 1 1262 11
Phase 1 2122699401028 208
Phase 1/2 21217502374 124
Phase 2 468681444815223 354
Phase 2/3 24311 11
Phase 3 721338213 66
Phase 4 1131 6
Not applicable 214 7
Unknown 51413163 33

Trials started per year

2021
11
2022
44
2023
32
2024
28
2025
24
2026
41

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Melanoma 555421084192314 252
Carcinoma, Non-Small-Cell Lung 1519341108 87
Carcinoma, Renal Cell 21610248111 63
Neoplasm Metastasis 21715142211 54
Neoplasms 141515124 51
Prostatic Neoplasms 110317121 35
Lung Neoplasms 74121314 32
Uveal Melanoma 11051021 29
Pancreatic Neoplasms 1151011 28
Carcinoma, Hepatocellular 787131 27

Most active sponsors

#SponsorTrialsPhase 3
1Bristol-Myers Squibb14136
2National Cancer Institute (NCI)658
3M.D. Anderson Cancer Center491
4H. Lee Moffitt Cancer Center and Research Institute170
5Memorial Sloan Kettering Cancer Center170
6Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins170
7The Netherlands Cancer Institute161
8Dana-Farber Cancer Institute150
9NYU Langone Health80
10Emory University70

Most studied interventions

#InterventionTrials
1Ipilimumab820
2Nivolumab548
3CTLA-4 Antigen144
4pembrolizumab75
5Carboplatin41
6Specimen Handling37
7Magnetic Resonance Spectroscopy32
8cabozantinib31
9Paclitaxel30
10Pemetrexed29

Evidence

Results reported
76.4%275 of 360 completed
Published
6.7%24 of 360 completed
Primary endpoint met
60%48 of 80 analyses
Median months to report
12

Documents disclosed

Protocol available
226
Statistical analysis plan
223
PubMed citations
54

Trial profile

Median enrollment
46
Median duration
60months
Countries
55
Study sites
11688

Who is enrolled

Adults
818
Children
53
Older adults
807
Healthy volunteers
7

Median enrollment by phase

Early Phase 1
14
Phase 1
24
Phase 1/2
46
Phase 2
50
Phase 2/3
278
Phase 3
654
Phase 4
181
Not applicable
40
Unknown
220

Where trials run

United States
591
France
119
Spain
103
Canada
99
Germany
98
Italy
97
Australia
88
United Kingdom
82
Netherlands
72
Poland
65

Busiest cities

#CityCountryTrials
1New YorkUnited States193
2HoustonUnited States160
3BostonUnited States150
4Los AngelesUnited States136
5ChicagoUnited States111
6PortlandUnited States105
7St LouisUnited States104
8PhiladelphiaUnited States97
9BaltimoreUnited States94
10NashvilleUnited States94

Terminations

Terminated
116
Withdrawn
34
Suspended
5
Stopped for recruitment
5.2%43 of 820 trials

Stated reasons

Other / unclear
69
Recruitment
43
Business decision
15
Funding
10
Lack of efficacy
7
Safety
6
Regulatory
3
COVID-19
2

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT06968988 Suspended Suspended Protocol amendment 2034-01-31
NCT05457959 Withdrawn Withdrawn Never opened 2030-12-01
NCT04840589 Suspended Suspended Other - Pending amendment. 2028-09-01
NCT05904080 Suspended Suspended Scheduled Interim Monitoring 2028-06-16
NCT05928806 Suspended Suspended Interim Analysis 2027-11-10
NCT04495010 Withdrawn Withdrawn Business objectives have changed 2027-10-23
NCT03604991 Suspended Suspended End of Initial Phase of Multi-phase protocol 2026-12-31
NCT05504642 Withdrawn Withdrawn Study stopped before submission for funding reasons 2026-07-31
NCT04151563 Withdrawn Withdrawn Business objectives have changed 2026-05-13
NCT03799445 Terminated Terminated \<75% participation 2026-04-14

Trial records