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A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma

A Phase II Trial of Avelumab, A Fully Human Antibody That Targets Cells Expressing PD-L1, in Patients With Recurrent or Progressive Osteosarcoma

NCT03006848•St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

This clinical trial seeks to determine if avelumab will be effective in facilitating removal of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab will be evaluated using dosing that has previously been determined in adult studies. Primary Objectives: * To estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma. * To estimate the 16-week progression free survival of patients with recurrent or progressive osteosarcoma after treatment with avelumab. Secondary Objective: * To describe the toxicities associated with the administration of avelumab in patients with recurrent or progressive osteosarcoma. * To assess the quality of life of patients with recurrent or progressive osteosarcoma undergoing treatment with avelumab, and to explore relationships between clinical factors and patient-reported health-related quality of life (HRQOL) outcomes. Exploratory Objectives: * To explore factors associated with response in patients treated with avelumab after recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression). * To measure parameters of immune activation including subsets of peripheral blood mononuclear cells (PBMCs) and serum markers of immune activation. * To evaluate the role of T-cells in immune checkpoint blockade via measures of cell proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and epigenetic programming.

Detailed Description

This is a Phase 2 study using a traditional Simon two-stage design. Patients 12 years or greater with recurrent/refractory osteosarcoma will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles. Progression free survival and response to therapy after 4 cycles of treatment will be assessed. In addition, the toxicity profile of avelumab in this population will be closely monitored.

Eligibility

Age

12 - 49 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be \> 12 years of age but \< 50 years of age at the time of enrollment.
•Patients must have histologic verification of osteosarcoma at initial diagnosis or relapse.
•Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy.
•Patients must have measurable disease, documented by clinical, radiographic or histologic criteria. Disease must be bi-dimensionally measurable by computed tomography (CT) or magnetic resonance imaging (MRI).
•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 of age.
•Patients must have a life expectancy of ≥ 6 weeks.
•Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
•1. Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study.
•2. Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent.
•3. Immunotherapies: at least 42 days must have elapsed since a prior therapy that included a monoclonal antibody or any other type of immunotherapy (e.g. chimeric antigen receptor (CAR) T cell therapy).
+24 more criteria

Exclusion Criteria

•Central nervous system (CNS) metastases.
•Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
•Active infection requiring systemic therapy.
•Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
•Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
•Patient who has received vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
•Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
•Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II, see Appendix II), or serious cardiac arrhythmia requiring medication.
•Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade \> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
+5 more criteria

Locations (4)

Children's Hospital Los Angeles

Los Angeles, California, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

St Jude Children's Research Hospital

Memphis, Tennessee, United States

Texas Children's Cancer Center

Houston, Texas, United States

Key Dates

Start Date

February 16, 2017

Primary Completion Date

March 18, 2020

Completion Date

March 18, 2020

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

Osteosarcoma

Interventions

Avelumab

DRUG

Questionnaires

OTHER

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

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OsteosarcomaOsteosarcoma Metastatic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma

Inclusion Criteria

Exclusion Criteria

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma

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