A Phase 2 interventional study of Pembrolizumab and Lenvatinib in Carcinoma, Squamous Cell and Anorectal Cancer, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's planned enrollment of 35 is below the median of 44 across 1,414 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment consists of lenvatinib (20 mg orally once daily) in combination with pembrolizumab (200 mg IV every 3 weeks). Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
Drug: Pembrolizumab · Drug: Lenvatinib
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.
Lenvatinib will be taken once daily, with or without food, at the same time each day.
Objective response rate (ORR)
Number of participants who achieve a complete or partial response based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Time frame: End of treatment up to 2 years
Disease control rate (DCR)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, by disease control rate (DCR), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Time frame: End of treatment up to 2 years
Progression free survival (PFS)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, by progression free survival (PFS), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Time frame: 2 years after end of treatment
Overall survival (OS)
To evaluate the efficacy of combination treatment of lenvatinib plus pembrolizumab, overall survival (OS), in patients with unresectable locally advanced and/or metastatic anorectal squamous cell carcinoma progressed on first-line chemotherapy.
Time frame: 2 years after end of treatment
Treatment Percentage
Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.
Time frame: End of treatment up to 2 years
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