LEAP 7902-009
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by blinded independent central review.
CLINICALTRIALS.GOV IDENTIFIER:
NCT04428151
When speaking to your doctor, please have the trial identifier number available.
All patients who enrol in the trial will receive medication while on the study.
37.5% will receive pembrolizumab along with lenvatinib
37.5% will receive standard of care chemotherapy (docetaxel, paclitaxel, cetuximab or capecitabine)*
25% will receive lenvatinib alone
*Your doctor will decide which treatment is best for you
Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.
Dates
Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.
Conditions
Squamous Cell Carcinoma of Head and Neck
Age Range
18 - No Age Maximum
Sex
All
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