Lenvatinib plus pembrolizumab for anal or rectal cancer that progressed after first 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.
This trial gives lenvatinib with pembrolizumab to people whose anorectal squamous cell cancer has spread or gotten worse after first-line chemotherapy or chemoradiation to see if the combination controls the cancer and is safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | Retifanlimab, chemotherapy, immunotherapy, pembrolizumab, lenvatinib |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06669572 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed anorectal squamous cell carcinoma that is unresectable locally advanced or metastatic and has progressed after first-line chemotherapy or chemoradiation, with measurable disease, are the intended participants.
Not a fit: Patients whose cancer is still controlled by first-line therapy or who are candidates for curative surgery are unlikely to benefit from this salvage treatment approach.
Why it matters
Potential benefit: If successful, the combination could shrink tumors, delay further progression, and potentially extend survival or symptom-free time for patients whose cancer no longer responds to standard first-line therapy.
How similar studies have performed: Similar combinations of anti-angiogenic agents with PD-1 inhibitors have shown promising activity in other tumor types, but data specific to anorectal squamous carcinoma are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.