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).
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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