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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:  April 4, 2014 (v1)
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: April 2014
Overall Status: Not yet recruiting
Study Start: April 2014
Primary Completion: May 2016 [Anticipated]
Study Completion: March 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:		 April 4, 2014
Last Update Posted: April 7, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators:
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 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.
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: 180 [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. Progression-Free Survival (PFS)
[ Time Frame: Approximately 26 months ]

Starting at week 9 and then every 6 weeks after randomization, until disease progression
2. Overall Survival (OS)
[ Time Frame: Approximately 3.5 years ]

Every 3 months during the survival follow-up phase
Secondary Outcome Measures:
1. Objective Response Rate
[ Time Frame: Approximately 3.5 years ]

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 and salivary gland or nonsquamous histologies
  • Subjects with active, known or suspected autoimmune disease
Open or close this module Contacts/Locations
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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