Conditions
Squamous Cell Carcinoma of Head and Neck
Trial Purpose
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.
NATIONAL TRIAL REFERENCE NUMBER
NCT04428151
EudraCT
2019-000569-19
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Trial
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
Trial Phase
Trial Phase 2
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.
Trial start and end dates
- Actual study start date 6 August 2020
- Estimated primary completion date 18 August 2024
- Estimated study completion date 18 August 2024
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about