Pembrolizumab +/− Lenvatinib for Head and Neck Cancer (LEAP-10 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

Eligibility Criteria

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured by surgery or radiation. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a certain level of physical ability (ECOG score 0-1). People who've had recent major surgery, live vaccines, other cancer treatments like pembrolizumab or similar drugs in the past are excluded.

Inclusion Criteria

My oropharyngeal cancer has been tested for HPV.

I am fully active or restricted in physically strenuous activity but can do light work.

My head or neck cancer is newly diagnosed and at stage IV.

My cancer is in my throat, mouth, or voice box.

My head or neck cancer cannot be cured with surgery or radiation.

Exclusion Criteria

I am currently being treated for an active infection.

I haven't had major heart problems or strokes in the last year.

I have been treated with specific immune therapy drugs before.

I have not received a live vaccine within the last 30 days.

I have cancer that has spread to my brain or spinal cord.

I have received an organ or tissue transplant from another person.

I have had or currently have lung inflammation treated with steroids.

I have a history of hepatitis B or active hepatitis C.

I am not allergic or severely sensitive to pembrolizumab or lenvatinib.

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

I have been treated with lenvatinib or pembrolizumab before.

I have trouble swallowing pills or taking liquid medicine.

My condition can be treated with the goal of curing it.

I have a severe fistula.

I have another cancer that is getting worse or was treated in the last 3 years.

Treatment Details

The study tests if combining Pembrolizumab with Lenvatinib improves response rates, slows disease progression, and extends survival compared to Pembrolizumab with a placebo. Participants will either receive both drugs or one drug plus a placebo without knowing which group they're in.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab with LenvatinibExperimental Treatment2 Interventions

Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.

Group II: Pembrolizumab with PlaceboActive Control2 Interventions

Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: