Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Registration Number
- NCT02105636
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 361
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Nivolumab Nivolumab Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression Arm B: Cetuximab/Methotrexate/Docetaxel Cetuximab 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 Arm B: Cetuximab/Methotrexate/Docetaxel Methotrexate 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 Arm B: Cetuximab/Methotrexate/Docetaxel 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
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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.
- Secondary Outcome Measures
Name Time Method Investigator-Assessed Progression-Free Survival (PFS) 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.Investigator-Assessed Objective Response Rate (ORR) 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.
Trial Locations
- Locations (47)
Local Institution - 0064
🇨🇳Taipei, Taiwan
Local Institution - 0051
🇨🇭Zuerich, Switzerland
Local Institution - 0004
🇺🇸Metairie, Louisiana, United States
Local Institution - 0048
🇩🇪Essen, Germany
Stanford University Medical Center
🇺🇸Stanford, California, United States
Local Institution - 0033
🇪🇸Valencia, Spain
Local Institution - 0066
🇰🇷Seoul, Korea, Republic of
Local Institution - 0055
🇧🇷Sao Paulo, Brazil
Local Institution - 0067
🇰🇷Seoul, Korea, Republic of
Local Institution
🇬🇧Surrey, United Kingdom
Local Institution - 0032
🇪🇸Barcelona, Spain
Local Institution - 0034
🇪🇸Madrid, Spain
Local Institution - 0065
🇨🇳Tainan, Taiwan
Local Institution - 0035
🇪🇸Barcelona, Spain
Local Institution - 0058
🇯🇵Kobe-shi, Hyogo, Japan
Local Institution - 0054
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0045
🇨🇦London, Ontario, Canada
Local Institution - 0002
🇺🇸Chicago, Illinois, United States
Dumc
🇺🇸Durham, North Carolina, United States
Local Institution - 0012
🇺🇸Columbus, Ohio, United States
Local Institution - 0007
🇺🇸Pittsburgh, Pennsylvania, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Local Institution - 0001
🇺🇸Atlanta, Georgia, United States
Univ Of Tx. Md Anderson
🇺🇸Hoston, Texas, United States
Local Institution - 0047
🇩🇪Berlin, Germany
Local Institution - 0052
🇩🇪Hamburg, Germany
Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
🇮🇹Meldola, FC, Italy
Local Institution - 0046
🇩🇪Hannover, Germany
Local Institution - 0050
🇩🇪Wuerzburg, Germany
Vanderbilt Cancer Clinic
🇺🇸Nashville, Tennessee, United States
Local Institution - 0031
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0049
🇩🇪Bonn, Germany
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0015
🇦🇷Berazategui, Buenos Aires, Argentina
Local Institution - 0013
🇦🇷San Miguel De Tucuman, Tucuman, Argentina
Local Institution - 0014
🇦🇷Cordoba, Argentina
Local Institution - 0056
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0060
🇯🇵Kashiwa, Chiba, Japan
Local Institution - 0062
🇯🇵Sapporo-shi, Hokkaido, Japan
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0038
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0063
🇯🇵Takatsuki, Osaka, Japan
Local Institution - 0059
🇯🇵Sunto-gun, Shizuoka, Japan
Local Institution - 0061
🇯🇵Tokyo, Japan
Local Institution - 0057
🇯🇵Akashi, Hyogo, Japan