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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Colorectal Cancer
• Intervention / Treatment: Biological: Cetuximab; Biological: Urelumab

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Oncology & Hematology Care Eastside
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: CA186-018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No