Avelumab for Osteosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan-Kettering Cancer Center, New York, NY
Osteosarcoma
Avelumab - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called avelumab can help treat osteosarcoma in children.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Avelumab will improve 4 primary outcomes, 2 secondary outcomes, and 9 other outcomes in patients with Osteosarcoma. Measurement will happen over the course of At the end of 4 cycles of avelumab (approximately 4 months).

Month 4
Progression-free survival
Response rate
Month 4
Progression-free Survival
Response Rate
Year 2
Target Toxicities
Target toxicities
Year 2
Change in Cell Proliferation
Change in Co-inhibitory Receptor Expression on CD8 T Cells
Change in cell proliferation
Change in co-inhibitory receptor expression on CD8 T cells
Week 8
Change in Parameters of Immune Activation
Change in parameters of immune activation
Year 2
Factors Associated With Response
Factors associated with response
Year 2
Change in Quality of Life

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

1 Treatment Group

Avelumab
1 of 1
Experimental Treatment

This trial requires 19 total participants across 1 different treatment group

This trial involves a single treatment. Avelumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

AvelumabAll 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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline prior to start of therapy and following 2 cycles of therapy (up to 8 weeks after last enrollment)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline prior to start of therapy and following 2 cycles of therapy (up to 8 weeks after last enrollment) for reporting.

Closest Location

Memorial Sloan-Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Osteosarcoma. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study.
Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent.
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).

Patient Q&A Section

What are common treatments for osteosarcoma?

"As a guideline, local osteosarcoma can be successfully treated with resection followed by adjuvant chemotherapy. Metastatic osteosarcoma treatment is more complex, owing to the presence of a greater number of metastases and a trend towards poorer survival. Chemotherapy with or without radiotherapy is often used. Surgery is often necessary, if the tumour is to be completely removed. Survival can be improved by the treatment of secondary, extraosseous, and bone-related disease." - Anonymous Online Contributor

Unverified Answer

What causes osteosarcoma?

"Osteosarcoma can occur spontaneously, and the number of cases that are due to genetic mutations is very small. The occurrence of osteosarcoma varies significantly in different race groups. Cancer may result from a combination of multiple factors, and it is highly recommended that both epidemiology and genetics be evaluated in order to determine the exact causes and risk factors of osteosarcoma." - Anonymous Online Contributor

Unverified Answer

What is osteosarcoma?

"The most common form of [osteosarcoma](https://www.withpower.com/clinical-trials/osteosarcoma) is osteoblastic. It typically presents as a solitary, non-blasting, bony pain-limiting lesion. The mean age at diagnosis is 25 with a range of 20–40. It occurs between 20% and 10% of all bone malignancy and only about 1% of all sarcomas. The median overall five year survival is 70%. In the adult skeletal system, its incidence is approximately 2 cases per 1,000,000. Male: female ratio is approximately 2:1." - Anonymous Online Contributor

Unverified Answer

Can osteosarcoma be cured?

"Treatment approaches for osteosarcoma have not changed in the last thirty years. Survival outcomes are still poor despite increased use of multimodal treatment. The ability of the tumor to invade and metastasize at the primary site of origin is a poor predictor of survival." - Anonymous Online Contributor

Unverified Answer

How many people get osteosarcoma a year in the United States?

"Although the exact incidence is unknown, an estimate of ∼10 to 20 new cases per year and ~1 death (if it isn't metastatic or unresectable), in the U.S., are possible (n=1.08×10). In the U.S., 0.12 per 1000 males, 0.058 per 1000 females were affected (2006 est)." - Anonymous Online Contributor

Unverified Answer

What are the signs of osteosarcoma?

"Signs involve, but are not limited to, swelling, changes in the joints' alignment, or an enlargement of one of the lymph nodes. As with other types of cancer, these signs may differ among the various subtypes of osteosarcoma." - Anonymous Online Contributor

Unverified Answer

How serious can osteosarcoma be?

"We must all be aware and be aware to be vigilant. If you notice a young adult(15-35) of slight build with a bone complaint, you must work to find out if there is anything serious going on as, once and again bone cancer is most frequently due to metastasis from a more serious problem such as a soft tissue sarcoma. Given the increasing incidence, there is a need for better training, earlier diagnosis and better treatment, to save life and to allow for optimum long-term quality of life for all patients with osteosarcoma." - Anonymous Online Contributor

Unverified Answer

What is the latest research for osteosarcoma?

"In order to understand the present literature for osteosarcoma as reported in mainstream medical journals, as well as as much as possible to find the very latest literature that is currently being published on osteosarcoma, I have searched the following databases:- PubMed, OvidSP, Embase, The Cochrane Library, and the New England Journal of Medicine on behalf of the World Health Organization (WHO). Also the following online resources:- CancerNet, U.S. National Cancer Institute, Centers for Disease Control, American Cancer Society, Cancer Research UK, American Association of Cancer Research, National Cancer Institute, and the European Molecular Biology Organization have also all been searched using different terms for osteosarcoma." - Anonymous Online Contributor

Unverified Answer

Has avelumab proven to be more effective than a placebo?

"The interim analysis shows that avellumab has increased PFS and OS significantly for the entire group compared to placebo group. For OS, avellumab shows superiority over placebo, but not for PFS only. However, analyses for subgroups including elderly patients might prove to be conflicting." - Anonymous Online Contributor

Unverified Answer

Is avelumab safe for people?

"Avelumab with an expanded-access option for pediatric patients enrolled in 3 multicenter trials is safe and associated with similar efficacy to historical studies in adults. The safety profile of avelumab is consistent with those observed in previous clinical trials in people with solid tumors. Avelumab did not exhibit neutropenic fever nor did patients at risk for pneumonitis require treatment interruption." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets osteosarcoma?

"The average age people are diagnosed with osteosarcoma is 15.0 years old. The most common age groups were 5-14 and 15-24. About half of patients in all age groups with osteosarcoma present at the time of diagnosis with a known hereditary predisposition. It is crucial to remember that children with osteosarcoma have a very unpredictable outcome and most cases are not diagnosed until the cancer has progressed as seen on imaging." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving avelumab?

"Results from a recent paper suggest avelumab could be effective in the treatment of advanced squamous-cell carcinoma and some relapsed epithelial [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer)s. A phase 2 study on avelumab for the treatment of these two types of cancer would need to be urgently initiated." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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