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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See 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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the intracranial ORR of the pembrolizumab and lenvatinib combination in patients with TNBC or NSCLC and brain metastases, as assessed according to the modified RECIST
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
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,242 Total Patients Enrolled
9 Trials studying Tumors
8,458 Patients Enrolled for Tumors
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,932 Total Patients Enrolled
4 Trials studying Tumors
1,989 Patients Enrolled for Tumors
Jordi AhnertPrincipal InvestigatorM.D. Anderson Cancer Center
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still available for participation in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov suggests that this medical study, which was published on January 20th 2022 is in the process of recruitment. It aims to engage 104 patients from a single site."
Answered by AI
To what extent is the cohort size in this trial?
"Affirmative. According to clinicaltrials.gov, this examination is actively searching for participants as of July 8th 2022, having first been posted on January 20th 2022. A total of 104 individuals must be recruited from a single research centre."
Answered by AI
To which ailments is pembrolizumab typically prescribed?
"Pembrolizumab can be prescribed to treat malignant neoplasms, aggressive melanomas that cannot be surgically removed, and microsatellite instability high cancers."
Answered by AI
Has the FDA sanctioned pembrolizumab for use?
"Although there is limited evidence of its efficacy, pembrolizumab has been awarded a safety rating of 2 due to the data collected in Phase 2 trials."
Answered by AI
Has research on pembrolizumab been expanded beyond the initial investigations?
"At the time of writing, there are 1032 ongoing clinical trials researching pembrolizumab; out of these studies, 134 have reached Phase 3. While much of this research is based in Sacramento, California, a total of 37062 medical locations worldwide are running tests with pembrolizumab."
Answered by AI
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