Actively Recruiting
Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment
Led by University of Chicago · Updated on 2026-04-15
35
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Histological confirmation of anorectal squamous cell carcinoma according to AJCC 8th edition
- Unresectable locally advanced or metastatic anorectal squamous cell carcinoma after progression on first line chemotherapy or chemoradiation
- Prior use of Retifanlimab immunotherapy allowed but not required
- Prior chemoradiation therapy, whether definitive or palliative, allowed
- Measurable disease based on RECIST 1.1 criteria, including lesions previously irradiated if progression shown within 28 days before registration
You will not qualify if you...
- Previous treatment with anti-PD-1, anti-PDL1, anti-PD-L2 agents, or other stimulatory/co-inhibitory T cell receptor agents except Retifanlimab
- History of serious immunotherapy-related adverse events requiring permanent discontinuation, including pneumonitis, myocarditis, renal failure, Guillain Barre syndrome, or myasthenia gravis
- Active autoimmune disease requiring ongoing chronic immunosuppressive treatment such as DMARDs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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