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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Cetuximab
Methotrexate
Docetaxel
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center
  • H. Lee Moffitt Cancer Center
  • Local Institution - 0001
  • Local Institution - 0002
  • Local Institution - 0004
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • University Of Michigan
  • Dumc
  • Local Institution - 0012
  • Local Institution - 0007
  • Vanderbilt Cancer Clinic
  • Univ Of Tx. Md Anderson
  • Huntsman Cancer Institute
  • Local Institution - 0031
  • Local Institution - 0015
  • Local Institution - 0013
  • Local Institution - 0014
  • Local Institution - 0054
  • Local Institution
  • Local Institution - 0055
  • Local Institution - 0038
  • Local Institution - 0045
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0047
  • Local Institution - 0049
  • Local Institution - 0048
  • Local Institution - 0052
  • Local Institution - 0046
  • Local Institution - 0050
  • Local Institution
  • Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0056
  • Local Institution - 0060
  • Local Institution - 0062
  • Local Institution - 0058
  • Local Institution - 0063
  • Local Institution - 0059
  • Local Institution - 0057
  • Local Institution - 0061
  • Local Institution - 0067
  • Local Institution - 0066
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0032
  • Local Institution - 0035
  • Local Institution - 0034
  • Local Institution - 0033
  • Local Institution - 0051
  • Local Institution - 0065
  • Local Institution - 0064
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Nivolumab

Arm B: Cetuximab/Methotrexate/Docetaxel

Arm Description

Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression

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

Outcomes

Primary Outcome Measures

Overall Survival (OS)
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.

Secondary Outcome Measures

Investigator-Assessed Progression-Free Survival (PFS)
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.
Investigator-Assessed Objective Response Rate (ORR)
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.

Full Information

First Posted
April 3, 2014
Last Updated
September 6, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02105636
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2014 (Actual)
Primary Completion Date
November 6, 2015 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Arm Title
Arm B: Cetuximab/Methotrexate/Docetaxel
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From date of randomization to date of death (Up to approximately 18 months)
Secondary Outcome Measure Information:
Title
Investigator-Assessed Progression-Free Survival (PFS)
Description
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.
Time Frame
From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
Title
Investigator-Assessed Objective Response Rate (ORR)
Description
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.
Time Frame
From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0001
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0002
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution - 0004
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dumc
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0012
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0007
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Univ Of Tx. Md Anderson
City
Hoston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution - 0031
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution - 0015
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
1880
Country
Argentina
Facility Name
Local Institution - 0013
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution - 0014
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0054
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution - 0055
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Local Institution - 0038
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0045
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Local Institution
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 0047
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Local Institution - 0049
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Local Institution - 0048
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution - 0052
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 0046
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0050
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0056
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Local Institution - 0060
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0062
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0058
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Local Institution - 0063
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution - 0059
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution - 0057
City
Akashi, Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Local Institution - 0061
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution - 0067
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution - 0066
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Local Institution - 0032
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0035
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0034
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0033
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution - 0051
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0065
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0064
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Local Institution
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32583557
Citation
Yen CJ, Kiyota N, Hanai N, Takahashi S, Yokota T, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Li WSK, Ferris RL, Gillison M, Endo T, Jayaprakash V, Tahara M. Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141). Head Neck. 2020 Oct;42(10):2852-2862. doi: 10.1002/hed.26331. Epub 2020 Jun 24.
Results Reference
derived
PubMed Identifier
31422216
Citation
Saba NF, Blumenschein G Jr, Guigay J, Licitra L, Fayette J, Harrington KJ, Kiyota N, Gillison ML, Ferris RL, Jayaprakash V, Li L, Brossart P. Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. Oral Oncol. 2019 Sep;96:7-14. doi: 10.1016/j.oraloncology.2019.06.017. Epub 2019 Jul 3.
Results Reference
derived
PubMed Identifier
30972702
Citation
Cocks K, Contente M, Simpson S, DeRosa M, Taylor FC, Shaw JW. A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck. Pharmacoeconomics. 2019 Aug;37(8):1041-1047. doi: 10.1007/s40273-019-00798-1.
Results Reference
derived
PubMed Identifier
30944020
Citation
Pai SI, Faivre S, Licitra L, Machiels JP, Vermorken JB, Bruzzi P, Gruenwald V, Giglio RE, Leemans CR, Seiwert TY, Soulieres D. Comparative analysis of the phase III clinical trials of anti-PD1 monotherapy in head and neck squamous cell carcinoma patients (CheckMate 141 and KEYNOTE 040). J Immunother Cancer. 2019 Apr 3;7(1):96. doi: 10.1186/s40425-019-0578-0.
Results Reference
derived
PubMed Identifier
29884413
Citation
Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington KJ, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Docampo LCI, Haddad R, Rordorf T, Kiyota N, Tahara M, Lynch M, Jayaprakash V, Li L, Gillison ML. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol. 2018 Jun;81:45-51. doi: 10.1016/j.oraloncology.2018.04.008. Epub 2018 Apr 17.
Results Reference
derived
PubMed Identifier
28939066
Citation
Kiyota N, Hasegawa Y, Takahashi S, Yokota T, Yen CJ, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Sum Kenneth Li W, Ferris RL, Gillison M, Namba Y, Monga M, Lynch M, Tahara M. A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141. Oral Oncol. 2017 Oct;73:138-146. doi: 10.1016/j.oraloncology.2017.07.023. Epub 2017 Sep 1.
Results Reference
derived
PubMed Identifier
28651929
Citation
Harrington KJ, Ferris RL, Blumenschein G Jr, Colevas AD, Fayette J, Licitra L, Kasper S, Even C, Vokes EE, Worden F, Saba NF, Kiyota N, Haddad R, Tahara M, Grunwald V, Shaw JW, Monga M, Lynch M, Taylor F, DeRosa M, Morrissey L, Cocks K, Gillison ML, Guigay J. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1104-1115. doi: 10.1016/S1470-2045(17)30421-7. Epub 2017 Jun 23.
Results Reference
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PubMed Identifier
27718784
Citation
Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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

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