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Monoclonal Antibodies

Avelumab + Lenvatinib for Brain Cancer

Phase 1
Recruiting
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 pre-dose up to 336 hours post-dose, assessed up to approximately 876 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I can do most activities by myself, regardless of my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 336 hours post-dose, assessed up to approximately 876 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 336 hours post-dose, assessed up to approximately 876 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Dose Escalation Part 1: Number of Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater Than or Equal to (>=) 3 Treatment-emergent Adverse Event (TEAEs) According to National Cancer Institute-CTCAE Version 5.0
Dose Expansion Part 2: Progression-free Survival (PFS) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
Secondary outcome measures
Dose Escalation (Part 1): Area Under the Plasma Concentration-Time Curve From the Time of Dosing to 24 Hours (AUC0-24 [hr]) of Lenvatinib
Dose Escalation Part 1: Area Under the Serum Concentration-Time Curve From the Time of Dosing 336 Hours (AUC0-336 [hr]) of Avelumab
Dose Escalation Part 1: Duration of Response (DOR) According to Response Assessment in Neuro-Oncology (RANO) Criteria as Assessed by Investigators
+22 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Investigations
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Endocrine disorders
6%
Immune system disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Infections and infestations
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

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
2018
Completed Phase 2
~2450
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,549 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,810 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,925 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05081180 — Phase 1
Brain Tumor Research Study Groups: Avelumab + Lenvatinib
Brain Tumor Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT05081180 — Phase 1
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081180 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of utilizing Avelumab in clinical experiments?

"Currently, there are 258 clinical trials exploring Avelumab with 42 of these studies being in the advanced Phase 3 stage. While numerous experiments for this medication take place in Nanning, Guangxi, a total of 8664 sites across the world are providing access to such research."

Answered by AI

What is the aggregate number of people engaged in this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, which was initially advertised on December 3rd 2021, is now actively sourcing patients. 50 candidates need to be sourced from 4 distinct research centres."

Answered by AI

For what ailments is Avelumab typically prescribed?

"Avelumab is frequently utilized in treating malignant neoplasms, as well as more specialized conditions such arcc, directives of progression, and radioactive iodine-refractory thyroid cancer."

Answered by AI

Is enrollment for this medical experiment still open?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is seeking participants and has been since December 3rd 2021; with its last update occurring November 4th 2022. This experiment requires 50 individuals from 4 distinct medical centers to complete it."

Answered by AI

To whom is this research opportunity available?

"This clinical trial requires participants to have tumors within the central nervous system and be aged between two and eighteen. The study is currently seeking a total of fifty patients."

Answered by AI

Is this research groundbreaking in its approach?

"Currently, the world-wide count of active studies using Avelumab stands at 258 across 1775 cities and 60 countries. The initial study was conducted in 2014 by EMD Serono Research & Development Institute, Inc., with 204 participants and concluded Phase 2 drug approval. Subsequent research has been carried out 102 times since then."

Answered by AI

What safety checks have been implemented to ensure the use of Avelumab is not hazardous?

"Considering the limited information at this stage of a Phase 1 trial, Avelumab was assigned an assessment score of 1."

Answered by AI

Are individuals aged 35 and above eligible to participate in this trial?

"This research project is seeking participants aged 2 to 18. The clinical trials registry reveals that there are 87 studies for minors and 303 intended for senior citizens."

Answered by AI

How extensive is the geographic coverage of this trial's implementation?

"The research team is seeking volunteers for this clinical trial from 4 different locations, including Washington University in Saint Louis, CHU Sainte-Justine in Montréal, and The Hospital for Sick Children in Toronto. Additionally, there are an additional four sites participating throughout the US and Canada."

Answered by AI
~21 spots leftby Dec 2025