Clinical trial NCT02110082: Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
Official title: A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been intolerant to both irinotecan- and oxaliplatin- based regimens
* Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment
* Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Men and women 18 and older
* Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Subjects must have a life expectancy of at least 3 months

Exclusion Criteria:

* Active or progressing brain metastases
* Other concomitant malignancies (with some exceptions per protocol)
* Nasopharyngeal carcinoma
* Active or history of autoimmune disease
* Positive test for Human Immunodeficiency Virus (HIV) 1\&2 or known AIDS
* History of any hepatitis (A,B or C)
* Known current drug or alcohol abuse
* Active Tuberculosis (TB)
* Use of anti-cancer treatments within 28 days
* Prior therapy with anti-CD137 antibody

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Duration of Objective Response (DOR)
timeFrame: Up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 years
measure: Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
timeFrame: Up to 2 years
measure: Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Area under the serum concentration-time curve from time zero to the time of last quantifiable serum concentration (AUC(0-T)) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
measure: Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Providence Oncology & Hematology Care Eastside
state: Oregon
city: Pittsburgh
country: United States
facility: Upmc Cancer Center
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: