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
1 other identifier
interventional
66
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Apr 2014
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 19, 2017
April 1, 2017
2.7 years
April 8, 2014
April 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Cohort 1: Urelumab + Cetuximab
EXPERIMENTALUrelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Cohort 2: Urelumab + Cetuximab
EXPERIMENTALUrelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Stanford University
Stanford, California, 94305, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Providence Oncology & Hematology Care Eastside
Portland, Oregon, 97213, United States
Upmc Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.
PMID: 38458639DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 10, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 19, 2017
Record last verified: 2017-04