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Monoclonal Antibodies
Pembrolizumab + Bevacizumab for Brain Cancer and Lung Cancer
Phase 2
Recruiting
Led By Harriett Kluger, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PD-L1 expression in tumor tissue from any site determined by the Dako 22C3 assay is required for patients with NSCLC
ECOG performance status < 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years from start of trial
Awards & highlights
Study Summary
This trial is studying a new combination of drugs to treat brain metastases from melanoma or NSCLC. The trial will enroll 53 patients and will last 84 months.
Who is the study for?
This trial is for adults with melanoma or non-squamous NSCLC who have small, untreated brain metastases not requiring immediate therapy. Participants must be in good general health with a life expectancy of at least 3 months and no severe autoimmune diseases, uncontrolled hypertension, significant bleeding disorders, or active infections like HIV/HBV/HCV. Pregnant/breastfeeding individuals and those treated with certain cancer drugs recently are excluded.Check my eligibility
What is being tested?
The study tests the combination of pembrolizumab plus bevacizumab on brain metastases from melanoma or NSCLC to assess effectiveness and safety. It includes biomarker studies to predict treatment benefits. The phase 2 trial will enroll 53 patients over approximately 84 months, with follow-up for an additional year.See study design
What are the potential side effects?
Potential side effects include immune-related inflammation in various organs, infusion reactions (like fever or chills), increased risk of bleeding due to bevacizumab's effect on blood vessels, high blood pressure, proteinuria (excess protein in urine), and possible interference with wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My NSCLC tumor shows PD-L1 presence based on a specific test.
Select...
I can do most of my daily activities on my own.
Select...
I have melanoma or non-squamous NSCLC with a small, untreated brain tumor not needing immediate treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years from start of trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years from start of trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
brain metastasis response rate (BMRR) using modified RECIST (mRECIST) criteria
Secondary outcome measures
Proportion of patients using steroids to control of cerebral edema for greater than 96 hours
Safety and toxicity of combination pembrolizumab and bevacizumab assessed using common terminology criteria for adverse events v. 4.
best overall response rate (ORR) by mRECIST criteria in the brain or RECIST criteria in the body
+1 moreOther outcome measures
PD-L1 expression and other potential predictive biomarkers in CNS, tumors and blood, correlated with response to treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: pembrolizumab plus bevacizumabExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,765 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,468 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,951 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My NSCLC tumor shows PD-L1 presence based on a specific test.My high blood pressure is not well controlled, even with medication.I do not have any other active cancers besides the one being studied, except for skin cancer.I haven't had chemotherapy or targeted therapy in the last 2 weeks and have recovered from previous treatment side effects.You have a current or past medical condition that could make it too risky for you to take the study drug, or that could make it hard to understand the study results.You are expected to live for at least 3 more months.I have symptoms from brain cancer spread as I start treatment.I haven't used steroids for brain swelling or nerve symptoms in the last week.I can do most of my daily activities on my own.My cancer has spread to the lining of my brain and spinal cord.I have high levels of protein in my urine.I have melanoma or non-squamous NSCLC with a small, untreated brain tumor not needing immediate treatment.I can provide a sample from my brain tumor surgery if needed.I can provide a biopsy or previous tumor sample for study, or discuss an exception.I have not received a live vaccine in the last 30 days.I have had treatments before, but none that targeted PD-1 or PD-L1.I've had radiation for brain cancer, but any treated area won't count unless it's gotten worse.I have recovered from side effects of treatments given over 4 weeks ago.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am not pregnant or breastfeeding.I am not currently in any other clinical trials or have been in one within the last 4 weeks.I cannot have an MRI due to a pacemaker or other metal implants.I don't have a history of significant bleeding or blood clotting issues.I have used blood thinners like dipyramidole or clopidogrel recently.I am not taking warfarin but can use certain blood thinners like enoxaparin.I haven't had any serious gut or throat hole issues in the last 6 months.I have a serious wound that is not healing.I have an autoimmune disease, but my thyroid is functioning normally.My organs are working well.I have had lung inflammation treated with steroids, or currently have lung inflammation or scarring.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2 before.I haven't had any systemic therapy in the last 14 days.I have had pneumonitis treated with steroids or have it now.My lung cancer is of the squamous type.I use low-dose steroids (≤10 mg prednisone or equivalent) for CNS symptoms.I have HIV, HBV, or HCV.I am currently coughing up blood.I haven't had major blood vessel problems or surgery in the last 6 months.I haven't had a heart attack or unstable chest pain in the last 3 months.I have not had a stroke or mini-stroke in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab plus bevacizumab
Awards:
This trial has 1 awards, including:- 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.
To what extent is this medical experiment recruiting participants?
"Affirmative. Based on the information posted on clinicaltrials.gov, this research study is actively enrolling participants; it was initially published on May 1st 2016 and has been revised most recently November 22nd 2022. Currently, the trial requires 53 patients to be recruited from 2 sites."
Answered by AI
What research has been done to explore the advantages of combining Pembrolizumab and Bevacizumab?
"Initially explored in 2004 at Memorial Sloan Kettering Basking Ridge, Pembrolizumab plus Bevacizumab has since undergone 1250 completed trials. Presently, there are 1,293 ongoing studies mostly located near New Haven Connecticut."
Answered by AI
Are participants being accepted for enrollment in this research project presently?
"Clinicaltrials.gov reveals that this medical investigation, which was initially shared on May 1st 2016, is actively searching for participants. The study's most recent update occurred on November 22nd 2022."
Answered by AI
To what degree is the combination of Pembrolizumab and Bevacizumab safe for individuals?
"Our assessment of pembrolizumab plus bevacizumab's safety was a 2, as there are some data supporting its security but no clinical evidence validating its efficacy."
Answered by AI
What medical conditions can be addressed through the combination of Pembrolizumab and Bevacizumab?
"Pembrolizumab in combination with Bevacizumab is a common treatment for unresectable melanoma. Additionally, this therapy may be beneficial to patients suffering from microsatellite instability high and instances of locally advanced nonsquamous non-small cell lung cancer with an increased risk of recurrence."
Answered by AI
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