ClinicalTrials.gov
History of Changes for Study: NCT02105636
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Latest version (submitted September 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 4, 2014 None (earliest Version on record)
2 May 5, 2014 Recruitment Status, Study Status, Contacts/Locations and References
3 May 7, 2014 Study Status and Contacts/Locations
4 May 27, 2014 Study Status and Contacts/Locations
5 May 30, 2014 Study Status
6 June 12, 2014 Contacts/Locations and Study Status
7 June 25, 2014 Contacts/Locations and Study Status
8 July 9, 2014 Contacts/Locations and Study Status
9 July 23, 2014 Contacts/Locations and Study Status
10 August 11, 2014 Contacts/Locations and Study Status
11 August 28, 2014 Contacts/Locations and Study Status
12 September 22, 2014 Contacts/Locations and Study Status
13 November 3, 2014 Contacts/Locations and Study Status
14 November 10, 2014 Contacts/Locations, Sponsor/Collaborators and Study Status
15 November 20, 2014 Contacts/Locations and Study Status
16 November 26, 2014 Contacts/Locations and Study Status
17 December 5, 2014 Contacts/Locations and Study Status
18 December 10, 2014 Study Status and Contacts/Locations
19 December 31, 2014 Study Status
20 January 27, 2015 Contacts/Locations and Study Status
21 February 6, 2015 Contacts/Locations and Study Status
22 February 19, 2015 Study Status
23 March 5, 2015 Contacts/Locations and Study Status
24 March 18, 2015 Outcome Measures, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
25 April 10, 2015 Contacts/Locations and Study Status
26 April 20, 2015 Contacts/Locations and Study Status
27 May 6, 2015 Contacts/Locations and Study Status
28 May 20, 2015 Contacts/Locations and Study Status
29 June 3, 2015 Study Status
30 June 22, 2015 Contacts/Locations and Study Status
31 July 3, 2015 Contacts/Locations and Study Status
32 July 17, 2015 Contacts/Locations and Study Status
33 August 6, 2015 Contacts/Locations and Study Status
34 August 19, 2015 Contacts/Locations and Study Status
35 September 2, 2015 Contacts/Locations and Study Status
36 September 16, 2015 Contacts/Locations and Study Status
37 October 5, 2015 Contacts/Locations and Study Status
38 October 15, 2015 Study Status
39 November 4, 2015 Contacts/Locations and Study Status
40 November 18, 2015 Contacts/Locations and Study Status
41 December 8, 2015 Study Status
42 December 21, 2015 Study Status
43 January 12, 2016 Recruitment Status, Contacts/Locations and Study Status
44 January 21, 2016 Contacts/Locations and Study Status
45 January 26, 2016 Study Status
46 February 10, 2016 Study Status
47 February 25, 2016 Study Status
48 March 11, 2016 Study Status
49 March 28, 2016 Study Status
50 April 12, 2016 Study Status
51 April 25, 2016 Study Status
52 May 10, 2016 Study Status
53 May 25, 2016 Study Status
54 June 9, 2016 Study Status
55 July 11, 2016 Study Status
56 July 26, 2016 Study Status
57 July 28, 2016 Study Status
58 August 8, 2016 Study Status
59 August 23, 2016 Study Status
60 November 15, 2016 Outcome Measures, Study Status, More Information, Study Design, Adverse Events, Baseline Characteristics and Participant Flow
61 January 10, 2017 Study Status and Baseline Characteristics
62 October 3, 2017 Study Status, References, Outcome Measures, Baseline Characteristics and Contacts/Locations
63 July 16, 2018 Contacts/Locations, Study Status and References
64 June 13, 2019 References, Study Status and Contacts/Locations
65 September 27, 2019 Study Status and Outcome Measures
66 December 14, 2021 Recruitment Status, Contacts/Locations, Study Status, Oversight, Outcome Measures and References
67 September 6, 2022 Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, Contacts/Locations, Study Status and Study Design
Comparison Format:
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Study NCT02105636
Submitted Date:  November 18, 2015 (v40)
Open or close this module Study Identification
Unique Protocol ID: CA209-141
Brief Title: Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
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)
Secondary IDs: 2013-003622-86 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2015
Overall Status: Recruiting
Study Start: May 2014
Primary Completion: October 2016 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: April 3, 2014
First Submitted that
Met QC Criteria:		 April 4, 2014
First Posted: April 7, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 November 18, 2015
Last Update Posted: November 20, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: Ono Pharmaceutical Co. Ltd
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 360 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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: CetuximabDrug: MethotrexateDrug: Docetaxel
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Approximately 28 months ]

Every 3 months during the survival follow-up phase
Secondary Outcome Measures:
1. Progression-Free Survival (PFS)
[ Time Frame: Approximately 28 months ]

Starting at week 9 and then every 6 weeks after randomization, until disease progression
2. Objective Response Rate (ORR)
[ Time Frame: Approximately 28 months ]

Starting at week 9 and then every 6 weeks after randomization, until disease progression or study drug is discontinued (whichever occurs later)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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, 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
Open or close this module Contacts/Locations
Central Contact Person: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of the email MUST contain NCT# and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations: United States, California
Stanford University Medical Center
[Active, not recruiting]
PaloAlto, California, United States, 94305
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
[Active, not recruiting]
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University
[Active, not recruiting]
Atlanta, Georgia, United States, 30322
United States, Illinois
University Of Chicago
[Active, not recruiting]
Chicago, Illinois, United States, 60637
United States, Louisiana
Crescent City Research Consortium, Llc
[Active, not recruiting]
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Dana Farber Cancer Institute
[Active, not recruiting]
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
[Active, not recruiting]
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Health System
[Active, not recruiting]
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Dumc
[Active, not recruiting]
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University
[Active, not recruiting]
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Upmc Cancer Center
[Active, not recruiting]
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt-Ingram Cancer Center
[Active, not recruiting]
Nashville, Tennessee, United States, 37232
United States, Texas
Univ Of Tx. Md Anderson
[Active, not recruiting]
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
[Active, not recruiting]
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Froedtert-Medical College Of Wisconsin
[Active, not recruiting]
Milawaukee, Wisconsin, United States, 53226
Argentina
Instituto Oncologico De Cordoba
[Recruiting]
Cordoba, Argentina, 5000
Contact:Contact: Martin Eduardo Richardet, Site 0014
Argentina, Buenos Aires
Coiba
[Recruiting]
Berazategui, Buenos Aires, Argentina, 1880
Contact:Contact: Mirta Susana Varela, Site 0015
Argentina, Tucuman
Centro Para La Atencion Integral Del Paciente Oncologico
[Recruiting]
San Miguel De Tucuman, Tucuman, Argentina, 4000
Contact:Contact: Felipe Salvador Palazzo, Site 0013
Brazil
Local Institution
[Active, not recruiting]
Sao Paulo, Brazil, 01321
Brazil, Rio Grande Do Sul
Local Institution
[Active, not recruiting]
Ijui, Rio Grande Do Sul, Brazil, 98700
Local Institution
[Active, not recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil, 90610
Canada, British Columbia
British Columbia Cancer Agency-Vancouver Ctr
[Recruiting]
Vancouver, British Columbia, Canada, V5Z4E6
Contact:Contact: Cheryl Ho, Site 0038 604-877-6000 Ext. X2445
Canada, Ontario
London Regional Cancer Program
[Recruiting]
London, Ontario, Canada, N6A 4L6
Contact:Contact: Donald Scott Ernst, Site 0045 519-685-8640
France
Local Institution
[Active, not recruiting]
Lyon Cedex 08, France, 69373
Local Institution
[Active, not recruiting]
Nice Cedex 2, France, 06189
Local Institution
[Active, not recruiting]
Villejuif, France, 94805
Germany
Local Institution
[Active, not recruiting]
Berlin, Germany, 12200
Universitaetsklinikum Bonn
[Active, not recruiting]
Bonn, Germany, 53127
Universitaetsklinikum Essen
[Active, not recruiting]
Essen, Germany, 45122
Uniklinikum Hamburg-Eppendorf
[Active, not recruiting]
Hamburg, Germany, 20246
Med Hochschule Hannover
[Active, not recruiting]
Hannover, Germany, 30625
Klinikum Der Universitaet
[Completed]
Wuerzburg, Germany, 97070
Hong Kong
Local Institution
[Active, not recruiting]
Hong Kong, Hong Kong
Italy
Local Institution
[Completed]
Milano, Italy, 20142
Local Institution
[Completed]
Napoli, Italy, 80131
Local Institution
[Active, not recruiting]
Padova, Italy, 35128
Italy, FC
Istituto Romagnolo Per Lo Studio E La Cura Dei Tumori
[Active, not recruiting]
Meldola, FC, Italy, 47014
Italy, MI
Local Institution
[Active, not recruiting]
Milano, MI, Italy, 20133
Italy, TO
Local Institution
[Active, not recruiting]
Torino, TO, Italy, 10126
Japan
Local Institution
[Active, not recruiting]
Akashi, Hyogo, Japan, 673-8558
Local Institution
[Active, not recruiting]
Tokyo, Japan, 135-8550
Japan, Aichi
Local Institution
[Active, not recruiting]
Nagoya, Aichi, Japan, 4648681
Japan, Chiba
Local Institution
[Active, not recruiting]
Kashiwa, Chiba, Japan, 2778577
Japan, Hokkaido
Local Institution
[Active, not recruiting]
Sapporo-shi, Hokkaido, Japan, 0608648
Japan, Hyogo
Local Institution
[Active, not recruiting]
Kobe-shi, Hyogo, Japan, 650-0017
Japan, Osaka
Local Institution
[Completed]
Takatsuki, Osaka, Japan, 5698686
Japan, Shizuoka
Local Institution
[Active, not recruiting]
Sunto-gun, Shizuoka, Japan, 4118777
Korea, Republic of
Local Institution
[Active, not recruiting]
Seoul, Korea, Republic of, 135-710
Local Institution
[Active, not recruiting]
Seoul, Korea, Republic of, 137-701
Netherlands
Local Institution
[Recruiting]
Amsterdam, Netherlands, 1081 HV
Contact:Contact: Site 0028
Local Institution
[Recruiting]
Groningen, Netherlands, 9713 AP
Contact:Contact: Site 0027
Local Institution
[Recruiting]
Leiden, Netherlands, 2333 ZA
Contact:Contact: Site 0026
Spain
Local Institution
[Active, not recruiting]
Barcelona, Spain, 08035
Local Institution
[Active, not recruiting]
Barcelona, Spain, 08036
Local Institution
[Active, not recruiting]
Madrid, Spain, 28041
Local Institution
[Active, not recruiting]
Valencia, Spain, 46010
Switzerland
Universitatsspital Zurich
[Active, not recruiting]
Zuerich, Switzerland, 8091
Taiwan
Local Institution
[Active, not recruiting]
Tainan, Taiwan, 704
Local Institution
[Active, not recruiting]
Taipei, Taiwan, 100
United Kingdom
Local Institution
[Recruiting]
Merseyside, United Kingdom, CH63 4JY
Contact:Contact: Site 0022
Local Institution
[Recruiting]
Surrey, United Kingdom, SM2 5PT
Contact:Contact: Site 0037
United Kingdom, Greater London
Local Institution
[Recruiting]
London, Greater London, United Kingdom, SW3 6JJ
Contact:Contact: Site 0025
United Kingdom, Greater Manchester
Local Institution
[Recruiting]
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact:Contact: Site 0023
United Kingdom, Hampshire
Local Institution
[Recruiting]
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact:Contact: Site 0024
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: BMS clinical trial educational resource
Available IPD/Information:
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