Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Head and Neck Cancer

Intervention / Treatment
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* Biological: Urelumab
* Biological: Cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Urelumab + Cetuximab<br>Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion | Biological: Urelumab<br> <br> * Other names: BMS-663513;Biological: Cetuximab<br> <br> |
| Experimental: Cohort 2: Urelumab + Cetuximab<br>Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion | Biological: Urelumab<br> <br> * Other names: BMS-663513;Biological: Cetuximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events | As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | Up to 2 years | 
| Duration of Objective Response (DOR) |  | Up to 2 years | 
| Progression Free Survival (PFS) |  | Up to 2 years | 
| Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513 |  | Up to 2 years | 
| Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| 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 |  | Up to 2 years | 
| Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| Total body clearance (CLT) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab |  | Up to 2 years | 
| Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab |  | Up to 2 years |