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.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04428151

When speaking to your doctor, please have the trial identifier number available.

About The Study

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 Icon

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 Icon

Dates

  • Actual study start date 6 August 2020
  • Estimated primary completion date 18 August 2024
  • Estimated study completion date 18 August 2024

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Squamous Cell Carcinoma of Head and Neck

Age Range Icon

Age Range

18 - No Age Maximum

Sex Icon

Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.