Recruiting
Phase 2

Lenvatinib & Pembrolizumab

Sponsor:

University of Chicago

Code:

NCT06669572

Conditions

Carcinoma, Squamous Cell

Anorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Lenvatinib

Study Details

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.

Conditions

Carcinoma, Squamous Cell

Anorectal Cancer

Study ID

NCT06669572

Start date

Jul 11, 2025

Status verified date

Apr, 2026

Completion date

Mar 26, 2029

Anticipated

Primary completion date

Mar 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 .

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm

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.

Interventions

Pembrolizumab

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

Lenvatinib will be taken once daily, with or without food, at the same time each day.

Primary outcome measure

  • Objective response rate (ORR) [ Time Frame: End of treatment up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

8557028222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Manik Amin

More Information

Sponsor

University of Chicago

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • chemotherapy
  • anorectal cancer
  • Lenvatinib
  • Pembrolizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-15.