Actively Recruiting
Lenvatinib Plus Pembrolizumab for Unresectable or Metastatic Anorectal Squamous Cell Carcinoma After First Line Chemotherapy
Led by University of Chicago · Updated on 2026-04-15
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of anorectal squamous cell carcinoma as per American Joint Committee on Cancer 8th edition
- Unresectable locally advanced or metastatic disease after progression on first line chemotherapy or chemoradiation
- Prior chemoradiation therapy allowed
- Measurable disease based on standard criteria
- Prior immunotherapy with Retifanlimab allowed but not required
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents except Retifanlimab
- History of serious immunotherapy-related side effects requiring permanent treatment stop
- Active autoimmune disease requiring ongoing immunosuppressive therapy such as disease-modifying antirheumatic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years (maximum 35 cycles)
Participants receive lenvatinib orally once daily and pembrolizumab as an IV infusion every 3 weeks for up to 2 years.
Pembrolizumab IV infusions every 3 weeks; daily oral lenvatinib
Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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