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Monoclonal Antibodies
Avelumab + Lenvatinib for Brain Cancer
Phase 1
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a Lansky performance status >= 50 for age <= 16 years or Karnofsky performance status >= 50 for age > 16 years at Screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a combination of two drugs is safe and effective in treating primary central nervous system tumors.
Who is the study for?
This trial is for children with confirmed primary CNS tumors who meet specific criteria based on tumor type and previous treatments. They must have measurable disease, be able to perform daily activities at a certain level (Lansky or Karnofsky performance status >= 50), and not have had major surgery or intracranial hemorrhage recently.
What is being tested?
The study tests Avelumab combined with Lenvatinib in two parts: first, finding the safest dose combination (Dose Escalation Part 1), then checking how well it works to stop tumor growth without worsening (Dose Expansion Part 2) by measuring progression-free survival.
What are the potential side effects?
Possible side effects of Avelumab and Lenvatinib include immune-related reactions, fatigue, high blood pressure, heart problems, bleeding issues, kidney dysfunction, protein in urine, digestive disturbances like diarrhea or vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities by myself, regardless of my age.
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
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
General disorders and administration site conditions
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
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: Avelumab + LenvatinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
Lenvatinib
2017
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,852 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,683 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is large or causing significant pressure inside my brain.My seizures are under control and do not affect my daily activities.I have not had major surgery or brain treatment in the last 28 days.I have a high-grade brain tumor and have had at least one treatment, or I have a specific type of brain tumor (diffuse midline glioma) and may have had up to one treatment or just radiotherapy.I can do most activities by myself, regardless of my age.I have a low-grade brain tumor, such as a pilocytic astrocytoma.I have not had a brain or spinal cord bleed in the last 28 days.My neurological condition has worsened in the past week.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab + Lenvatinib
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.