We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02110082
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Head and Neck Cancer Biological: Urelumab Biological: Cetuximab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 1: Urelumab + Cetuximab
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Biological: Urelumab
Other Name: BMS-663513
Biological: Cetuximab
Experimental: Cohort 2: Urelumab + Cetuximab
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Biological: Urelumab
Other Name: BMS-663513
Biological: Cetuximab



Primary Outcome Measures :
  1. The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events [ Time Frame: 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 :
  1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
  2. Duration of Objective Response (DOR) [ Time Frame: Up to 2 years ]
  3. Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]
  4. Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513 [ Time Frame: Up to 2 years ]
  5. Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  6. Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  7. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  8. 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 [ Time Frame: Up to 2 years ]
  9. Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  10. Total body clearance (CLT) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  11. Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  12. Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110082


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Providence Oncology & Hematology Care Eastside
Portland, Oregon, United States, 97213
United States, Pennsylvania
Upmc Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02110082     History of Changes
Other Study ID Numbers: CA186-018
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents