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A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma
Phase 2 trial testing Avelumab in Osteosarcoma in 19 participants. Completed in 18 March 2020.
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 16 February 2017 |
| Primary completion | 18 March 2020 |
| Estimated completion | 18 March 2020 |
| Sites | 4 locations across United States |
St. Jude Children's Research Hospital
Adults 12 to 49, any sex, with Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The study is designed by treating RECIST response \[complete response + partial response (CR+PR)\] after 4-cycle treatment of avelumab and the 16-week progression-free survival (PFS) as dual binary endpoints. Patients who fail to be evaluated at the end of the 4-cycle will be counted as failure.
| Group | Value | 95% CI |
|---|---|---|
| Avelumab | 0 | 0 – 0 |
The study is designed by treating RECIST response \[complete response + partial response (CR+PR)\] after 4-cycle treatment of avelumab and the 16-week progression-free survival (PFS) as dual binary endpoints. Patients who fail to be evaluated at the end of the 4-cycle will be counted as failure.
| Group | Value | 95% CI |
|---|---|---|
| Progression-free Survival | 8.0 | 6.7 – 9.1 |
Target toxicities for avelumab treatment are defined as any grade 3-5 dyspnea, infusion-related reactions, or immune related adverse events at least possibly attributable to the agent observed anytime during the 26-cycle treatment period that a patient is on study (including the period between off treatment and off study).
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Target Toxicities | 2 |
Time frame: Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 3 years from study enrollment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Avelumab |
|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Blood and lymphatic system disorders | Vascular disorders | — |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Infections and infestations | Respiratory, thoracic and mediastinal disorders | — |
| Nervous system disorders | Nervous system disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| Investigations | Investigations | — |
| Investigations | Investigations | — |
| Cardiac disorders | Cardiac disorders | — |
| Reaction | System | Avelumab |
|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Infections and infestations | Infections and infestations | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — |
| Investigations | Investigations | — |
| Investigations | Investigations | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| Cardiac disorders | Cardiac disorders | — |
| Cardiac disorders | Cardiac disorders | — |
| Endocrine disorders | Endocrine disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| General disorders and administration site conditions | General disorders | — |
| General disorders and administration site conditions | General disorders | — |
| General disorders and administration site conditions | General disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Immune system disorders | Immune system disorders | — |
| Infections and infestations | Infections and infestations | — |
| Investigations | Investigations | — |
| Investigations | Investigations | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| Nervous system disorders | Nervous system disorders | — |
| Nervous system disorders | Nervous system disorders | — |
| Nervous system disorders | Nervous system disorders | — |
| Renal and urinary disorders | Renal and urinary disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Respiratory, thoracic and mediastinal disorders, Blood and lymphatic system disorders, Neoplasms benign, malignant and unspecified, Respiratory, thoracic and mediastinal disorders, Infections and infestations, Nervous system disorders, Gastrointestinal disorders, Metabolism and nutrition disorders.
Data from ClinicalTrials.gov NCT03006848 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing