Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02105636
First received: April 3, 2014
Last updated: September 22, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to find out whether Nivolumab will significantly improve progression-free survival and/or overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Drug: Nivolumab
Drug: Cetuximab
Drug: Methotrexate
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 26 months ] [ Designated as safety issue: No ]
    Starting at week 9 and then every 6 weeks after randomization, until disease progression

  • Overall Survival (OS) [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Every 3 months during the survival follow-up phase


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Starting at week 9 and then every 6 weeks after randomization, until disease progression or study drug is discontinued (whichever occurs later)


Estimated Enrollment: 180
Study Start Date: May 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Drug: Nivolumab
Other Name: BMS-936558
Active Comparator: Arm B: Cetuximab/Methotrexate/Docetaxel

Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression

OR

Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression

OR

Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression

Drug: Cetuximab Drug: Methotrexate Drug: Docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
  • Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
  • Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases are not allowed
  • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or nonsquamous histologies
  • Subjects with active, known or suspected autoimmune disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105636

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 51 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02105636     History of Changes
Other Study ID Numbers: CA209-141, 2013-003622-86
Study First Received: April 3, 2014
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic
Spain: Spanish Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Hong Kong: Department of Health

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Docetaxel
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014