Phase 2 Study of Lenvatinib and Pembrolizumab for Advanced or Metastatic Anal or Rectal Squamous Cell Carcinoma After First Line Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining lenvatinib and pembrolizumab to treat patients with anorectal squamous cell carcinoma that has spread to other parts of the body and has not responded to standard care. This Phase II study focuses on patients whose cancer has worsened after initial treatment, including chemotherapy or chemoradiation. The goal is to understand how well this combination works in this advanced cancer setting. Participants will receive lenvatinib orally once daily at a dose of 20 mg, along with pembrolizumab given as an intravenous infusion of 200 mg every three weeks. Pembrolizumab treatment will continue for up to two years or a maximum of 35 cycles. This is a single-arm trial, meaning all enrolled patients will receive this combination treatment without comparison to another group. During the study, participants will undergo assessments to monitor tumor response using specific criteria, safety evaluations, and overall health status. Researchers will measure outcomes such as the objective response rate at the end of treatment, disease control, progression-free survival, and overall survival for up to two years after treatment ends. The total participation period can last up to two years or more depending on treatment duration and follow-up monitoring.

Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment