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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

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Intratumoral Ipilimumab · 1 trial · 1 indication

Phase 1 1
NCT02812524Ipilimumab for Head and Neck Cancer PatientsSquamous Cell Carcinoma of the Head and Neck
ACTIVE NOT_RECRUITING18 Analytics
PHASE1ACTIVE NOT_RECRUITING
Ipilimumab for Head and Neck Cancer Patients
Squamous Cell Carcinoma of the Head and NeckUnlock trial analytics

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 to 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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Frequently asked questions about Intratumoral Ipilimumab

What is Intratumoral Ipilimumab used for?

Intratumoral Ipilimumab is an investigational small molecule being studied for the treatment of squamous cell carcinoma of the head and neck. It is administered directly into the tumor and is currently in Phase 1 clinical development for this indication.

Who makes Intratumoral Ipilimumab?

Intratumoral Ipilimumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with squamous cell carcinoma of the head and neck.

What phase is Intratumoral Ipilimumab in?

Intratumoral Ipilimumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 18 patients.

What clinical trials is Intratumoral Ipilimumab in?

Intratumoral Ipilimumab is being studied in a single Phase 1 clinical trial with the identifier NCT02812524, titled "Ipilimumab for Head and Neck Cancer Patients." The trial is active but not recruiting, enrolling 18 patients with squamous cell carcinoma of the head and neck in the United States.

Is Intratumoral Ipilimumab the same as Ipilimumab?

Intratumoral Ipilimumab is a formulation of ipilimumab that is administered directly into the tumor, rather than systemically. The clinical trial NCT02812524 evaluates this intratumoral route of administration in patients with squamous cell carcinoma of the head and neck.