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 Tumors (RECIST) 1.1 as assessed by blinded independent central review.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT04428151

When you talk with your doctor or clinical trial team member, please have the trial identifier 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.

Conditions Icon

Conditions

Squamous Cell Carcinoma Of Head And Neck

Age Range Icon

Age Range

18+

Sex Icon

Sex

All

About the trial

All patients who enroll 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 Current trial phase

Trial Phase 2

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start Icon Trial start and end dates
  • Trial start date August 6, 2020
  • Estimated primary completion date August 18, 2024
  • Estimated trial completion date August 18, 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.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

NATIONAL TRIAL REFERENCE NUMBER

NCT04428151

When you talk with your doctor or clinical trial team member, please have the trial identifier number available.

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