Lenvatinib plus pembrolizumab for anal or rectal cancer that progressed after first treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, single-center trial treats patients with unresectable locally advanced or metastatic anorectal squamous cell carcinoma that progressed after first-line chemotherapy or chemoradiation using the oral kinase inhibitor lenvatinib combined with the PD-1 antibody pembrolizumab. Participants must have measurable disease by RECIST 1.1 and may have had prior chemoradiation; prior use of retifanlimab is allowed. The study collects information on safety, side effects, and tumor responses to the combination regimen. Treatment is delivered and monitored at the University of Chicago Medicine Comprehensive Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation \[core, incisional, or excisional\], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.
* Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.
* Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.
* Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.

Exclusion Criteria:

* Has received prior therapy with an anti-PD-1, anti- PDL1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) with the exception of Retifanlimab immunotherapy.
* Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.
* Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .

Where it's running

• University of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Intake
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 8557028222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.