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Angiogenesis Inhibitor

Pembrolizumab + Lenvatinib for Advanced Cancers with Brain Metastases

Phase 2

Recruiting

Led By Jordi Ahnert

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Has ECOG performance status of 0 or 1

Male/female patients who are at least 18 years of age with histologically or cytologically confirmed TNBC, NSCLC, or solid tumors other than TNBC and NSCLC with brain metastasis

Must not have

Received prior therapy with specific medications

Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it is more effective than other treatments for patients with solid tumors and brain metastases. The primary endpoint is intracranial objective response rate, or the percentage of patients whose tumors shrink or disappear.

Who is the study for?

Adults with certain types of cancer (TNBC, NSCLC, or other solid tumors) that have spread to the brain. They must have good kidney function, controlled blood pressure, and no serious liver issues. Patients should not be pregnant or breastfeeding and must agree to use contraception. Those with specific lung cancer mutations or untreated spinal cord compression are excluded.

What is being tested?

The trial is testing the combination of Pembrolizumab (an immunotherapy drug) and Lenvatinib (a medication that inhibits tumor blood vessel growth) in patients with different cancers that have metastasized to the brain. The goal is to see how well this combo works on brain tumors using a two-stage study design.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, liver problems, kidney issues, abnormal bleeding or clotting times, allergic reactions to drugs involved in treatment as well as risks associated with immune system activation such as inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 or older with confirmed TNBC, NSCLC, or another solid tumor with brain metastasis.

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I agree to use birth control.

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I have a brain tumor that can be measured.

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I am not pregnant or breastfeeding and follow the required contraceptive measures.

Exclusion Criteria

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

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I have taken specific medications before.

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I have an immune system disorder or I am on long-term steroids.

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I have untreated spinal cord compression or cancer spread to the lining of my brain.

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I do not have major heart issues or problems with my digestive system that prevent me from taking pills.

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I have never had lung inflammation, serious infections, or HIV.

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I have another cancer that has gotten worse or needed treatment in the last 5 years.

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I have not received any live vaccines in the last 30 days.

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I haven't had cancer treatment in the last 28 days.

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I do not have heart rhythm issues, bleeding disorders, abnormal blood minerals, severe kidney problems, a history of organ transplant, or cancer invading major blood vessels.

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My lung cancer has specific genetic changes.

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I have liver cancer.

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I have active tuberculosis.

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I am on systemic steroids or immunosuppressants for my condition.