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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105636
• Other study ID #: CA209-141
• Secondary ID: 2013-003622-86
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2014
• Est. completion date: September 10, 2021

Study information

• Verified date: August 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: September 10, 2021
• Est. primary completion date: November 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Nivolumab

• Cetuximab

• Methotrexate

• Docetaxel

Locations

Country	Name	City	State
Argentina	Local Institution - 0015	Berazategui	Buenos Aires
Argentina	Local Institution - 0014	Cordoba
Argentina	Local Institution - 0013	San Miguel De Tucuman	Tucuman
Brazil	Local Institution - 0054	Ijui	RIO Grande DO SUL
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 0055	Sao Paulo
Canada	Local Institution - 0045	London	Ontario
Canada	Local Institution - 0038	Vancouver	British Columbia
France	Local Institution	Lyon Cedex 08
France	Local Institution	Nice Cedex 2
France	Local Institution	Villejuif Cedex
Germany	Local Institution - 0047	Berlin
Germany	Local Institution - 0049	Bonn
Germany	Local Institution - 0048	Essen
Germany	Local Institution - 0052	Hamburg
Germany	Local Institution - 0046	Hannover
Germany	Local Institution - 0050	Wuerzburg
Hong Kong	Local Institution	Hong Kong
Italy	Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori	Meldola	FC
Italy	Local Institution	Milano	MI
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Torino	TO
Japan	Local Institution - 0057	Akashi, Hyogo
Japan	Local Institution - 0060	Kashiwa	Chiba
Japan	Local Institution - 0058	Kobe-shi	Hyogo
Japan	Local Institution - 0056	Nagoya	Aichi
Japan	Local Institution - 0062	Sapporo-shi	Hokkaido
Japan	Local Institution - 0059	Sunto-gun	Shizuoka
Japan	Local Institution - 0063	Takatsuki	Osaka
Japan	Local Institution - 0061	Tokyo
Korea, Republic of	Local Institution - 0066	Seoul
Korea, Republic of	Local Institution - 0067	Seoul
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Leiden
Spain	Local Institution - 0032	Barcelona
Spain	Local Institution - 0035	Barcelona
Spain	Local Institution - 0034	Madrid
Spain	Local Institution - 0033	Valencia
Switzerland	Local Institution - 0051	Zuerich
Taiwan	Local Institution - 0065	Tainan
Taiwan	Local Institution - 0064	Taipei
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Southampton	Hampshire
United Kingdom	Local Institution	Surrey
United Kingdom	Local Institution	Wirral	Merseyside
United States	University Of Michigan	Ann Arbor	Michigan
United States	Local Institution - 0001	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Local Institution - 0002	Chicago	Illinois
United States	Local Institution - 0012	Columbus	Ohio
United States	Dumc	Durham	North Carolina
United States	Univ Of Tx. Md Anderson	Hoston	Texas
United States	Local Institution - 0004	Metairie	Louisiana
United States	Local Institution - 0031	Milwaukee	Wisconsin
United States	Vanderbilt Cancer Clinic	Nashville	Tennessee
United States	Local Institution - 0007	Pittsburgh	Pennsylvania
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of randomization to date of death (Up to approximately 18 months)
Secondary	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.	From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
Secondary	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.	From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form