Lenvatinib + Pembrolizumab for Anal Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with anal or rectal cancer that has spread and isn't responding to standard treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and have a type of cancer the study targets.

Inclusion Criteria

I am 18 years old or older.

I have been mostly active and able to carry on all pre-disease activities without restriction recently.

I have HIV and it is well-controlled with medication.

My anorectal cancer has been confirmed by a biopsy.

My anorectal cancer cannot be surgically removed and has worsened after initial treatment.

Exclusion Criteria

I have or had lung inflammation that needed steroids.

I have coughed up bright red blood recently.

My scans show my tumor is affecting a major blood vessel or has holes.

I do not have conditions affecting medication absorption.

I have a severe fistula.

I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

I have cancer that has spread to my brain or spinal cord.

I have received a stem cell or organ transplant from another person.

My heart's pumping ability is below the normal range.

I am currently being treated for an infection.

I had radiotherapy less than 2 weeks ago.

I have been treated with drugs targeting immune checkpoints.

I have not received a live vaccine in the last 30 days.

I have an autoimmune disease treated with drugs in the last 2 years.

Treatment Details

The trial is testing the combination of two drugs, Lenvatinib and Pembrolizumab, to evaluate their safety and effectiveness in treating advanced anal or rectal cancer that's resistant to initial treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment armExperimental Treatment2 Interventions

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.

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: