Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Conditions

• Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lenvatinib — DRUG
  20 mg once daily, taken as oral capsules
• Pembrolizumab — BIOLOGICAL
  200 mg 30-minute IV infusion on day 1 of each 21-day cycle
• Docetaxel — DRUG
  75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle
• Capecitabine — DRUG
  1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
• Paclitaxel — DRUG
  80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
• Cetuximab — DRUG
  400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
• Lenvatinib — DRUG
  24 mg once daily, taken as oral capsules

Study Details

Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse. The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.

Key Dates

Start date

Aug 6, 2020

Status verified

Nov 2025

Primary completion

May 31, 2024

Completion

Oct 30, 2025

Study Design

Enrollment

408 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lenvatinib + Pembrolizumab
  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.
• Active Comparator: SOC Chemotherapy
  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.
• Active Comparator: Lenvatinib Monotherapy
  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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 45 months ]

Locations (55)

Related coverage on Hipa.ai

• Pembrolizumab/Lenvatinib Combo Fails to Improve OS in Head and Neck SCC
  Pembrolizumab · May 25, 2025 · ClinicalTrials.gov

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