A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors)
Categories (click each to see list of all clinical trials associated with that category): Head and Neck
Current Status: Open to accrual
Phase: II
Principal Investigator: Ganti, Apar
Contact Information:
Brandie Booker, RN
402-559-8197
brandie.booker@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04428151?term=NCT04428151&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures: Objective Response Rate (ORR) [ Time Frame: Up to approximately 4 years ] ORR is defined as the percentage of participants who have 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 occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
Secondary Outcome Measures:
1.Progression-Free Survival (PFS) [ Time Frame: Up to approximately 4 years ] - PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). 2.Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]- OS is defined as the time from randomization to death due to any cause. 3. Duration of Response (DOR) [ Time Frame: Up to approximately 4 years ] DOR is 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 occurs first. Responses are according to modified RECIST 1.1 as assessed by BICR. 4.Number of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ] An AE is 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 will be presented. 5.Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) [ Time Frame: Up to approximately 4 years ] An AE is 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 will be presented.