Your session is about to expire
← Back to Search
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 or older with confirmed TNBC, NSCLC, or another solid tumor with brain metastasis.
Select...
I agree to use birth control.
Select...
I have a brain tumor that can be measured.
Select...
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:Select...
I have taken specific medications before.
Select...
I have an immune system disorder or I am on long-term steroids.
Select...
I have untreated spinal cord compression or cancer spread to the lining of my brain.
Select...
I do not have major heart issues or problems with my digestive system that prevent me from taking pills.
Select...
I have never had lung inflammation, serious infections, or HIV.
Select...
I have another cancer that has gotten worse or needed treatment in the last 5 years.
Select...
I have not received any live vaccines in the last 30 days.
Select...
I haven't had cancer treatment in the last 28 days.
Select...
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.
Select...
My lung cancer has specific genetic changes.
Select...
I have liver cancer.
Select...
I have active tuberculosis.
Select...
I am on systemic steroids or immunosuppressants for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Patients with other solid tumor types and brain metastases
Group II: Cohort 2Experimental Treatment2 Interventions
Patients with NSCLC and brain metastases
Group III: Cohort 1Experimental Treatment2 Interventions
Patients with TNBC and brain metastases
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
2017
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,223 Total Patients Enrolled
9 Trials studying Tumors
8,457 Patients Enrolled for Tumors
Eisai Inc.Industry Sponsor
521 Previous Clinical Trials
159,670 Total Patients Enrolled
4 Trials studying Tumors
1,989 Patients Enrolled for Tumors
Jordi AhnertPrincipal InvestigatorM.D. Anderson Cancer Center
Jordi Rodon Ahnert, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
1,349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken specific medications before.I have an immune system disorder or I am on long-term steroids.I have untreated spinal cord compression or cancer spread to the lining of my brain.I still feel side effects from my past treatments.I have brain metastases with little to no symptoms.I do not have major heart issues or problems with my digestive system that prevent me from taking pills.I am fully active or restricted in physically strenuous activity but can do light work.I have never had lung inflammation, serious infections, or HIV.I have another cancer that has gotten worse or needed treatment in the last 5 years.I have not received any live vaccines in the last 30 days.I haven't had cancer treatment in the last 28 days.My organs are functioning well.My cancer may or may not have spread beyond my brain.I am 18 or older with confirmed TNBC, NSCLC, or another solid tumor with brain metastasis.I agree to use birth control.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.My lung cancer has specific genetic changes.I had radiotherapy less than 14 days before starting the study treatment.I have a brain tumor that can be measured.I have liver cancer.I have active tuberculosis.I am not pregnant or breastfeeding and follow the required contraceptive measures.I am on systemic steroids or immunosuppressants for my condition.I had surgery or radiation for up to 5 brain tumors at least 3 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: Cohort 2
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.