Monoclonal Antibodies

Avelumab for Brain Tumor

Nationwide Children's Hospital, Columbus, OH

Avelumab +1 morePhase 1RecruitingResearch 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

Other protocol defined inclusion criteria could apply

Be younger than 65 years old

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow upspre-dose up to 336 hours post-dose, assessed up to approximately 876 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Study Summary

This trial will test if a combination of two drugs is safe and effective in treating primary central nervous system tumors.

Eligible Conditions

Brain Tumor

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

There may be additional criteria for joining the study as determined by the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ pre-dose up to 336 hours post-dose, assessed up to approximately 876 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow ups ~ 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 2019 Phase 3 trial • 792 Patients • NCT02395172

20%

Decreased appetite

20%

Cough

19%

Dyspnoea

18%

Fatigue

14%

Nausea

14%

Infusion related reaction

14%

Asthenia

13%

Anaemia

13%

Pyrexia

13%

Weight decreased

12%

Back pain

11%

Diarrhoea

11%

Constipation

10%

Vomiting

10%

Disease progression

Headache

Rash

Chills

Pruritus

Upper respiratory tract infection

Arthralgia

Haemoptysis

Productive cough

Musculoskeletal pain

Hypothyroidism

Pain in extremity

Insomnia

Oedema peripheral

Myalgia

Pleural effusion

Malaise

Death

Stomatitis

Neuropathy peripheral

Pneumonia

Chronic obstructive pulmonary disease

Pneumonitis

Peripheral sensory neuropathy

Pain

Neutropenia

Superior vena cava syndrome

Acute respiratory failure

Sepsis

Respiratory tract infection

Metastases to central nervous system

Pericardial effusion

Hyperglycaemia

White blood cell count decreased

Depressed level of consciousness

Acute kidney injury

Confusional state

Mucosal inflammation

Cardiac arrest

Cardiac tamponade

Colitis

Pulmonary embolism

Hypercalcaemia

Respiratory failure

Interstitial lung disease

Hypoxia

Femoral neck fracture

Atrial fibrillation

Metastases to bone

Hypersensitivity

Alopecia

Lung infection

Malignant pleural effusion

Abdominal pain

Hyperkalaemia

Neutrophil count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Docetaxel

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

FDA approved

Lenvatinib

FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

433 Previous Clinical Trials

113,832 Total Patients Enrolled

EMD Serono Research & Development Institute, Inc.Lead Sponsor

75 Previous Clinical Trials

30,714 Total Patients Enrolled

Medical ResponsibleStudy Director

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

283 Previous Clinical Trials

68,437 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

Recent research and studies

clinicaltrials.govStudy

Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors

2021. "Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081180.