Lenvatinib + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+128 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing if lenvatinib combined with pembrolizumab or lenvatinib alone is better for patients with head and neck cancer that hasn't responded to other treatments. Lenvatinib stops cancer growth, and pembrolizumab boosts the immune system to fight cancer. Lenvatinib has shown better curative effects when combined with other treatments compared to its use as a single agent.

Eligibility Criteria

This trial is for adults with recurrent/metastatic head and neck squamous cell carcinoma that worsened after platinum therapy and anti-PD-1/PD-L1 treatment. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), agree to use contraception, and not have other active cancers or severe health conditions.

Inclusion Criteria

Pre-study imaging showing disease progression per RECIST 1.1 criteria

Measurable disease by CT or MRI per RECIST 1.1 criteria

Female participants must not be pregnant or breastfeeding, meet contraceptive criteria, and agree not to donate or freeze/store eggs

+8 more

Exclusion Criteria

I have undergone 4 or more treatments for my recurring or spreading cancer.

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

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

+20 more

Participant Groups

The study tests lenvatinib combined with pembrolizumab against standard chemotherapy, and also lenvatinib alone. It aims to see if the combination is more effective based on tumor response rates. Patients are randomly assigned to these treatments.

3Treatment groups

Experimental Treatment

Active Control

Group I: Lenvatinib + PembrolizumabExperimental Treatment2 Interventions

Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.

Group II: Lenvatinib MonotherapyActive Control1 Intervention

Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.

Group III: SOC ChemotherapyActive Control4 Interventions

Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.

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

🇺🇸 Approved in United States as Lenvima for: