Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse. The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.
With Amendment 7, participants will discontinue lenvatinib and pembrolizumab and lenvatinib monotherapy, unless discussed with the Sponsor. A protocol-specified periodic safety review was completed with a data cut-off of 31-May-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 34 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
408
20 mg once daily, taken as oral capsules
200 mg 30-minute IV infusion on day 1 of each 21-day cycle
75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle
1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
24 mg once daily, taken as oral capsules
City of Hope ( Site 1519)
Duarte, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
Los Angeles, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)
New Haven, Connecticut, United States
Georgetown University Medical Center ( Site 1520)
Washington D.C., District of Columbia, United States
UF Health ( Site 1554)
Gainesville, Florida, United States
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 45 months
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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. Note: The appearance of one or more new lesions was also considered PD.
Time frame: Up to approximately 45 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to approximately 45 months
Duration of Response (DOR)
DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 45 months
Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.
Time frame: Up to approximately 5 years
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE was presented.
Time frame: Up to approximately 5 years
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Mid Florida Hematology and Oncology Center ( Site 1606)
Orange City, Florida, United States
Cleveland Clinic Florida ( Site 1596)
Weston, Florida, United States
Georgia Cancer Center at Augusta University ( Site 1575)
Augusta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)
Marietta, Georgia, United States
Memorial Health University Medical Center ( Site 1626)
Savannah, Georgia, United States
...and 110 more locations