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

September 6, 2022 updated by: Bristol-Myers Squibb

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

361

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution - 0014
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1880
        • Local Institution - 0015
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution - 0013
  • Brazil
      • Sao Paulo, Brazil, 01321-001
        • Local Institution - 0055
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0054
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Local Institution
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0038
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Local Institution - 0045
  • France
      • Lyon Cedex 08, France, 69373
        • Local Institution
      • Nice Cedex 2, France, 06189
        • Local Institution
      • Villejuif Cedex, France, 94805
        • Local Institution
  • Germany
      • Berlin, Germany, 12200
        • Local Institution - 0047
      • Bonn, Germany, 53127
        • Local Institution - 0049
      • Essen, Germany, 45122
        • Local Institution - 0048
      • Hamburg, Germany, 20246
        • Local Institution - 0052
      • Hannover, Germany, 30625
        • Local Institution - 0046
      • Wuerzburg, Germany, 97070
        • Local Institution - 0050
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Italy
      • Milano, Italy, 20142
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
    • FC
      • Meldola, FC, Italy, 47014
        • Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
    • MI
      • Milano, MI, Italy, 20133
        • Local Institution
    • TO
      • Torino, TO, Italy, 10126
        • Local Institution
  • Japan
      • Akashi, Hyogo, Japan, 673-8558
        • Local Institution - 0057
      • Tokyo, Japan, 135-8550
        • Local Institution - 0061
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0056
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • Local Institution - 0060
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0062
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Local Institution - 0058
    • Osaka
      • Takatsuki, Osaka, Japan, 5698686
        • Local Institution - 0063
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution - 0059
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Local Institution - 0067
      • Seoul, Korea, Republic of, 137-701
        • Local Institution - 0066
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution
      • Groningen, Netherlands, 9713 AP
        • Local Institution
      • Leiden, Netherlands, 2333 ZA
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0032
      • Barcelona, Spain, 08036
        • Local Institution - 0035
      • Madrid, Spain, 28041
        • Local Institution - 0034
      • Valencia, Spain, 46010
        • Local Institution - 0033
  • Switzerland
      • Zuerich, Switzerland, 8091
        • Local Institution - 0051
  • Taiwan
      • Tainan, Taiwan, 704
        • Local Institution - 0065
      • Taipei, Taiwan, 100
        • Local Institution - 0064
  • United Kingdom
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution
    • Merseyside
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Local Institution
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0001
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0002
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Local Institution - 0004
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • DUMC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0012
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0007
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Cancer Clinic
    • Texas
      • Hoston, Texas, United States, 77030
        • Univ Of Tx. Md Anderson
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution - 0031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
  • Subjects with active, known or suspected autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Drug: Nivolumab
Other Names:
  • 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: Docetaxel
Drug: Methotrexate
Drug: Cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of randomization to date of death (Up to approximately 18 months)
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
From date of randomization to date of death (Up to approximately 18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-Assessed Progression-Free Survival (PFS)
Time Frame: From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who:

  • Die without a reported progression were considered to have progressed on the date of their death.
  • Did not progress or die were censored on the date of their last evaluable tumor assessment.
  • Without any on study tumor assessments and did not die were censored on their date of randomization.
  • Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
Investigator-Assessed Objective Response Rate (ORR)
Time Frame: From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)
ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2014

Primary Completion (Actual)

November 6, 2015

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-141
  • 2013-003622-86 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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