Lenvatinib + Pembrolizumab for Anal Cancer

Recruiting in 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

Written informed consent and HIPAA authorization for release of personal health information prior to registration

I am 18 years old or older.

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

+11 more

Exclusion Criteria

I have or had lung inflammation that needed steroids.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study

+21 more

Participant Groups

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: