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

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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

Tracking Information
First Submitted Date  ICMJE April 8, 2014
First Posted Date  ICMJE April 10, 2014
Last Update Posted Date April 19, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2014)
Safety and Tolerability, and Maximum tolerated Dose (MTD) of BMS-663513 [ Time Frame: Approximately 2 years ]
Safety and tolerability, and MTD of BMS-663513 in combination with Cetuximab as measured by the incidence, potential significance, and clinical importance of adverse events, measured up to at least 60 days after last dose of Urelumab, 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
Change History Complete list of historical versions of study NCT02110082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
  • Objective response rate (ORR) [ Time Frame: Up to 2 years ]
  • Duration of Objective Response (DOR) [ Time Frame: Up to 2 years ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]
  • Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-663513 [ Time Frame: Up to 2 years ]
  • Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  • Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 2 years ]
  • Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  • Total body clearance (CLT) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  • Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
  • Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2014)
  • Efficacy - Antitumor Activity of BMS-663513 in combination with Cetuximab as measured by the objective response rate, duration of objective response, and progression free survival [ Time Frame: Every 8 weeks for the first 24 weeks, then every 12 weeks thereafter (Approximately 2 years) ]
  • Immunogenicity - Occurrence of specific anti-drug antibodies to Urelumab from measurements [ Time Frame: Day 2 of Cycles 1-5, every 12 weeks after Cycle 5; at end of study and at follow-up (Approximately 2 years) ]
  • Maximum observed serum concentration (Cmax) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, Phamacokinetics (PK) and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
  • Time of maximum observed serum concentration (Tmax) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 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 [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 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 [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
  • Elimination half-life (T-HALF) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
  • Total body clearance (CLT) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
  • Volume of distribution at steady-state (Vss) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
  • Trough observed concentration (Cmin) of BMS-663513 in combination with Cetuximab [ Time Frame: Days 2, 3, 5, 8, and 15 of Cycle 1; Days 2 and 8 of Cycle 2; Day 2 of Cycles 3-5. After Cycle 5, PK and samples for Urelumab will be collected every 4 cycles. Then at end of study and at follow-up (Approximately 2 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Head and Neck Cancer
Intervention  ICMJE
  • Biological: Urelumab
    Other Name: BMS-663513
  • Biological: Cetuximab
Study Arms  ICMJE
  • Experimental: Cohort 1: Urelumab + Cetuximab
    Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
    Interventions:
    • Biological: Urelumab
    • Biological: Cetuximab
  • Experimental: Cohort 2: Urelumab + Cetuximab
    Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
    Interventions:
    • Biological: Urelumab
    • Biological: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
66
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2014)
104
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02110082
Other Study ID Numbers  ICMJE CA186-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP