Lenvatinib in Combination With Pembrolizumab vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy

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Objetivo do estudo

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.

Veja informações completas sobre o teste em Clinicaltrials.gov

IDENTIFICADOR CLINICALTRIALS.GOV

NCT04428151

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Sobre o estudo

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.

Fase 2

Testa o medicamento ou a vacina em aproximadamente 100 a 500 voluntários. No caso de medicamentos, os voluntários geralmente têm a doença ou condição que o medicamento em investigação foi concebido para tratar. Em estudos de vacinas, os voluntários são geralmente saudáveis.