NCT06669572

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

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

Conditions

• Carcinoma, Squamous Cell
• Anorectal Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
DRUG	Lenvatinib	Lenvatinib will be taken once daily, with or without food, at the same time each day.

Timeline

• Start date: 2025-07-11
• Primary completion: 2029-03-26
• Completion: 2029-03-26
• First posted: 2024-11-01
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study