The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
At investigator's choice, paclitaxel 100 mg/m\^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each 21-day cycle
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Time frame: Up to ~25 months
Duration of Response (DOR)
For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Time frame: Up to ~25 months
Progression-free Survival (PFS)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to ~25 months
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Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
New Haven, Connecticut, United States
Helen F. Graham Cancer Center & Research Institute ( Site 0214)
Newark, Delaware, United States
Baptist MD Anderson Cancer Center ( Site 0215)
Jacksonville, Florida, United States
Orlando Health, Inc. ( Site 0216)
Orlando, Florida, United States
Regions Hospital ( Site 0227)
Saint Paul, Minnesota, United States
Washington University School of Medicine ( Site 0240)
St Louis, Missouri, United States
Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)
Buffalo, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)
Mineola, New York, United States
Novant Health Presbyterian ( Site 0261)
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center ( Site 0266)
Winston-Salem, North Carolina, United States
...and 25 more locations
Overall Survival (OS)
OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to ~25 months
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Time frame: Up to ~39 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported.
Time frame: Up to ~25 months