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Kinase Inhibitor

Lenvatinib + Pembrolizumab for Anal Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of consent

The Eastern Cooperative Oncology Group Performance Status of 0-1 within 7 days prior to registration

Must not have

Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Active hemoptysis (bright red blood of at least 0.5 teaspoon)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if combining lenvatinib with pembrolizumab is safe and effective for treating anal/rectal cancer that has spread and is not responding to standard treatment."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, Lenvatinib can cause high blood pressure, fatigue, diarrhea; Pembrolizumab may lead to immune system reactions affecting organs, skin rash, flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

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My anorectal cancer has been confirmed by a biopsy.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had lung inflammation that needed steroids.

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I have coughed up bright red blood recently.

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

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I do not have conditions affecting medication absorption.

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I have a severe fistula.

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

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

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

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

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I am currently being treated for an infection.

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I had radiotherapy less than 2 weeks ago.

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I have been treated with drugs targeting immune checkpoints.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Overall survival (OS)

Progression free survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Lenvatinib

2017

Completed Phase 4

~2070