Anorectal Cancer, Carcinoma, Squamous Cell
Conditions
Keywords
chemotherapy, anorectal cancer, Lenvatinib, Pembrolizumab
Brief summary
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.
Interventions
DRUGPembrolizumab
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.
DRUGLenvatinib
Lenvatinib will be taken once daily, with or without food, at the same time each day.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | End of treatment up to 2 years | Number of participants who achieve a complete or partial response based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | End of treatment up to 2 years | 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. |
| Progression free survival (PFS) | 2 years after end of treatment | 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. |
| Overall survival (OS) | 2 years after end of treatment | 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. |
| Treatment Percentage | End of treatment up to 2 years | Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5. |
Countries
United States
Contacts
CONTACTClinical Trials Intake
Outcome results
None listed