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Multi-targeted Tyrosine Kinase Inhibitor
A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
Phase 2
Waitlist Available
Led By Paul E. Oberstein, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 18
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination therapy for metastatic gastroesophageal cancer in patients who have progressed on other treatments. The hope is that this new combination will provide better outcomes than existing treatments.
Eligible Conditions
- Stomach Cancer
- Esophageal cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Overall Survival (OS)
Progression-Free Survival (PFS)
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: Lenvatinib & PembrolizumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2017
Completed Phase 4
~2070
Pembrolizumab
2017
Completed Phase 3
~3130
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,053 Total Patients Enrolled
Paul E. Oberstein, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of or currently have a lung condition called pneumonitis that is not caused by an infection.You have already been treated with a type of medication called anti-PD-1, anti-PD-L1, or anti-PD-L2.You have a condition that affects the way your body absorbs lenvatinib or other nutrients from your food.You have a bleeding disorder or have had significant bleeding within the past 3 weeks.You have a heart condition that requires certain medications to control abnormal heart rhythms or severe slowing of the heart.You are allergic to pembrolizumab or lenvatinib or any of the ingredients in these medications.You have had a hole or tear in your digestive system in the past.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer or early-stage cervical cancer.You have cancer that has spread to your brain or the protective lining of your brain. If you have had previous treatment for brain metastases and they are not growing or causing symptoms, you may still be eligible to participate. However, you must stop taking steroids for at least a week before starting the trial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib & Pembrolizumab
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.