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OpenTrials
Completed

NCT Number: NCT02110082

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urelumab

Biological

Other names: BMS-663513

Cetuximab

Biological

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2014
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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