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Monoclonal Antibodies

Avelumab for Osteosarcoma

Phase 2
Waitlist Available
Led By Michael W. Bishop, MD, MS
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following completion of therapy for last participant (up to 2 years after enrollment)
Awards & highlights

Study Summary

This trial is testing if avelumab will help remove all of the tumor in children who have a relapse of osteosarcoma. Avelumab will be given using a dose that has been previously been determined in adult studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline prior to start of therapy and following 2 cycles of therapy (up to 8 weeks after last enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline prior to start of therapy and following 2 cycles of therapy (up to 8 weeks after last enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Response Rate
Secondary outcome measures
Target Toxicities
Other outcome measures
Change in Cell Proliferation
Change in Co-inhibitory Receptor Expression on CD8 T Cells
Change in Parameters of Immune Activation
+2 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%
Gastrointestinal disorders
6%
Endocrine disorders
6%
General disorders and administration site conditions
6%
Cardiac disorders
6%
Nervous system disorders
6%
Investigations
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Infections and infestations
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: AvelumabExperimental Treatment2 Interventions
All participants with recurrent/refractory osteosarcoma who consent to the study. Interventions: Avelumab and quality of life questionnaires.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,558 Total Patients Enrolled
13 Trials studying Osteosarcoma
1,343 Patients Enrolled for Osteosarcoma
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,908,031 Total Patients Enrolled
2 Trials studying Osteosarcoma
183 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,304 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,599 Patients Enrolled for Osteosarcoma

Frequently Asked Questions

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

What are some possible risks associated with Avelumab?

"Avelumab's safety is estimated to be a 2. This is due to it being in Phase 2 trials, where there is data indicating it is safe but no evidence yet of the medication's efficacy."

Answered by AI

At how many different facilities is this trial being managed?

"There are 4 recruitment centres for this study, situated in Memphis, New york and Los Angeles. There are also 4 other locations. If you want to participate in the trial, it is best to choose a centre near to your location to cut down on travel costs."

Answered by AI

Is this research project recruiting patients at present?

"This particular clinical trial, which was first made public on February 16th 2017 and last updated on August 22nd 2022, is not presently looking for patients. However, there are many other trials (over 200) that are currently enrolling."

Answered by AI

Does this research project require participants to be over the age of 40?

"As per this clinical trial's inclusion criteria, the age limit for participants is 49 years old and they must be at least 12."

Answered by AI

To your knowledge, does a similar study exist?

"Avelumab has been studied since 2014. The initial clinical trial was completed in 2014 and was sponsored by EMD Serono Research & Development Institute, Inc.. Following the first study in 2014, which involved 204 participants, Avelumab received its Phase 2 drug approval. Today there are 116 live studies for Avelumab across 1024 cities and 52 countries."

Answered by AI

How many patients have been enrolled in this clinical trial to date?

"This particular clinical trial is no longer searching for new participants. The study was originally posted on February 16th, 2017 but the most recent update was on August 22nd, 2022. There are currently 114 other studies actively recruiting patients with osteosarcoma and 116 trials involving Avelumab that are still enrolling patients."

Answered by AI

What is the historical efficacy of Avelumab in similar cases?

"Since 2014, when avelumab was first studied at Port Macquarie Base Hospital, there have been 211 completed clinical trials. At the moment, 116 different studies are ongoing; with numerous research centres located in Memphis, Tennessee."

Answered by AI

To whom is this trial available?

"This study is accepting 19 people with osteosarcoma between the ages of 12 and 49. Most notable, applicants should meet the following criteria: Patients must be > 12 years of age but < 50 years of age at the time of enrollment., Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy., Patients must have a performance status of ≥ 50 using the Karnofsky scale for patients > 16 years of age and the Lansky scale for patients ≤ 16 years old., Patients must have a life expectancy of ≥ 6 weeks., Patients must have fully recovered from the acute toxic effects of"

Answered by AI
~2 spots leftby Apr 2025