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

Recruiting in Palo Alto (17 mi)

+156 other locations

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

I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception as required.

Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed

My cancer can be measured and has grown in previously treated areas.

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Exclusion Criteria

I have not had cancer treatment or been in a drug trial in the last 4 weeks.

I am currently being treated for an active infection.

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

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Treatment Details

Interventions

Lenvatinib (Tyrosine Kinase Inhibitor)
Pembrolizumab (Monoclonal Antibodies)
Placebo ()

Trial OverviewThe 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.

Participant Groups

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: