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Intratumoral Ipilimumab

Phase 1

Squamous Cell Carcinoma of the Head and Neck | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 24, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02812524Ipilimumab for Head and Neck Cancer PatientsPHASE1 ACTIVE NOT_RECRUITING 18Nov 18, 2016Dec 1, 2026Apr 24, 20261 United States
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Study Endpoints
Primary Endpoints
Surgery delay
7-10 Days

The percentage of patients with surgery delayed possibly related to the study drug.

Secondary Endpoints
Feasibility of paired tissue sample acquisition
7-10 Days
Acceptance of study
28 Days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intratumoral IpilimumabEXPERIMENTALPatients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.
Interventions
NameTypeDescription
Intratumoral IpilimumabDRUGPatients with a planned resection of SCCHN will have a biopsy procedure 7-10 days prior to surgery and receive an injection of ipilimumab directly into a tumor.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with SCCHN who are planned for surgical resection and in the opinion of the surgeon are able to safely undergo tissue biopsy plus intratumoral (IT) injection in advance, with special consideration given to risk of occlusion or compression of airway or major vessels in...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT02812524studyFirstPostDate: changed