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

Phase 1

Completed

• Conditions: Colorectal Cancer; Head and Neck Cancer
• Interventions: Biological: Urelumab; Biological: Cetuximab

• Registration Number: NCT02110082
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: Urelumab + Cetuximab	Urelumab	Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Cohort 1: Urelumab + Cetuximab	Cetuximab	Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Cohort 1: Urelumab + Cetuximab	Urelumab	Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Cohort 2: Urelumab + Cetuximab	Cetuximab	Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

Primary Outcome Measures

Name	Time	Method
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events	Approximately 2 years	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

Secondary Outcome Measures

Name	Time	Method
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513	Up to 2 years
Duration of Objective Response (DOR)	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
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
Objective response rate (ORR)	Up to 2 years
Progression Free Survival (PFS)	Up to 2 years
Maximum observed serum concentration (Cmax) 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
Total body clearance (CLT) 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
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab	Up to 2 years

Trial Locations

Locations (7)

Stanford University; 🇺🇸 Stanford, California, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Upmc Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Providence Oncology & Hematology Care Eastside; 🇺🇸 Portland, Oregon, United States

University Of Chicago; 🇺🇸 Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States