Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
|ClinicalTrials.gov Identifier: NCT02105636|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2014
Results First Posted : January 11, 2017
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Nivolumab Drug: Cetuximab Drug: Methotrexate Drug: Docetaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||November 6, 2015|
|Estimated Study Completion Date :||October 27, 2020|
Experimental: Arm A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Other Name: 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
Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression
Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression
- Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint [ Time Frame: From date of randomization to date of death, approximately 18 months ]Overall survival 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. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.
- Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization to 3, 6, 9, and 12 months ]The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
- Progression-Free Survival (PFS) [ Time Frame: Randomization to disease progression or death, whichever occurs first; Approximately 5 years ]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 (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who 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.
- Objective Response Rate (ORR) [ Time Frame: Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years ]ORR was defined as the proportion 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. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.
- Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), and Study Drug-Related SAEs in All Treated Participants at Primary Endpoint [ Time Frame: Date of first dose of study drug to 30 days post last dose of study drug, approximately 18 months ]AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105636
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|