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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110082
• Other study ID #: CA186-018
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2014
• Last updated: April 17, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• Urelumab

• Cetuximab

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University Of Chicago	Chicago	Illinois
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Upmc Cancer Center	Pittsburgh	Pennsylvania
United States	Providence Oncology & Hematology Care Eastside	Portland	Oregon
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate (ORR)		Up to 2 years
Secondary	Duration of Objective Response (DOR)		Up to 2 years
Secondary	Progression Free Survival (PFS)		Up to 2 years
Secondary	Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513		Up to 2 years
Secondary	Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab		Up to 2 years
Secondary	Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab		Up to 2 years
Secondary	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
Secondary	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
Secondary	Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab		Up to 2 years
Secondary	Total body clearance (CLT) of BMS-663513 in combination with Cetuximab		Up to 2 years
Secondary	Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab		Up to 2 years
Secondary	Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab		Up to 2 years

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form