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

Primary Purpose

Colorectal Cancer, Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Urelumab
Cetuximab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University Of Chicago
  • Johns Hopkins University
  • Dana Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Providence Oncology & Hematology Care Eastside
  • Upmc Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: Urelumab + Cetuximab

Cohort 2: Urelumab + Cetuximab

Arm Description

Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate (ORR)
Duration of Objective Response (DOR)
Progression Free Survival (PFS)
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-663513 in combination with Cetuximab
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
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab

Full Information

First Posted
April 8, 2014
Last Updated
April 17, 2017
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02110082
Brief Title
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Urelumab + Cetuximab
Arm Type
Experimental
Arm Description
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Arm Title
Cohort 2: Urelumab + Cetuximab
Arm Type
Experimental
Arm Description
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Urelumab
Other Intervention Name(s)
BMS-663513
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Primary Outcome Measure Information:
Title
The primary safety endpoint is the incidence, potential significance, and clinical importance of adverse events
Description
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
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
Up to 2 years
Title
Duration of Objective Response (DOR)
Time Frame
Up to 2 years
Title
Progression Free Survival (PFS)
Time Frame
Up to 2 years
Title
Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513
Time Frame
Up to 2 years
Title
Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years
Title
Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years
Title
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
Title
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
Title
Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years
Title
Total body clearance (CLT) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years
Title
Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years
Title
Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Providence Oncology & Hematology Care Eastside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Upmc Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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