Nivolumab for Osteosarcoma

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Minnesota, Minneapolis, MN
Osteosarcoma+3 More
Nivolumab - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Osteosarcoma

Study Summary

This study is evaluating whether a combination of two drugs may help treat osteosarcoma.

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Eligible Conditions

  • Osteosarcoma
  • Osteosarcoma Recurrent
  • Osteosarcoma Metastatic
  • Osteosarcoma in Children

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Nivolumab will improve 1 primary outcome and 5 secondary outcomes in patients with Osteosarcoma. Measurement will happen over the course of Approximately 4 months.

Approximately 4 months
Compare the 4-month progression-free survival rate to historical controls
Approximately 5 years
Describe adverse events
Estimate 1-year and 2-year Overall Survival
Objective Response Rate
Progression-Free Survival
Progression-Free Survival and Objective Response Rate

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Regorafenib and Nivolumab

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nivolumab 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.

Regorafenib and Nivolumab
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 5 years for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Osteosarcoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must have a measurable disease on a CT scan or MRI scan, as defined by RECIST 1.1 show original
The patient has a Lansky (≤ 16 years of age) or Karnofsky (>16 years of age) performance score of ≥ 70, or Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 show original
This means that the person's hemoglobin level is at least 8 grams per deciliter, and they are allowed to receive blood transfusions. show original
: The patient has an absolute neutrophil count (ANC) of at least 1000/mm3. show original
Platelets ≥ 75 000/mm3
Patients must be at least five years old to be enrolled, and the study will try to ensure that fifty percent of patients are under the age of 21. show original
The patient has been diagnosed with a high grade osteosarcoma that has recurred or is resistant to treatment show original
Must be able to swallow intact pills
ALT and AST ≤ 3 x institutional upper limit of normal (ULN) or ≤ 5.0 x institutional ULN if considered due to tumor Serum albumin ≥ 3 g/dL
Serum total bilirubin ≤ 1.5 x institutional ULN. NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study

Patient Q&A Section

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

What is osteosarcoma?

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Osteosarcoma (the cancer that forms in bone) can present in the limbs, in the abdomen, beneath the skin, or in the chest cavity. Osteosarcoma is typically diagnosed during adolescence or early adulthood. More than 80% of men and > 80% of women with osteosarcoma are at high risk for developing lung and/or pleural metastases. Osteosarcoma can be deadly, with a 3-year survival rate of 21.8 %.

Unverified Answer

What are common treatments for osteosarcoma?

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Overall, the standard treatment for osteosarcoma is surgery, and chemotherapy is rarely used. Radiotherapy also rarely treats osteosarcoma. However, for localized tumors that are surgically resectable, chemotherapy with adjuvant radiotherapy improves local control and survival.

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Can osteosarcoma be cured?

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The use of chemotherapy with local control (radiation) may aid in the cure of osteosarcoma. There are significant differences in the disease course of osteosarcoma in different patients. Therefore, there is little consensus on what constitutes treatment success, since many tumors regress without treatment. It is the case that in most cases where this regimen has not achieved remission, or the disease has become resistant to treatment, the prognosis is very bad.

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

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Although osteosarcoma is the third most common nonrhabdomyosarcoma soft tissue sarcoma after Ewing sarcoma and leiomyosarcoma, osteosarcoma appears to be much more common in the Western than in the Eastern regions of the United States. We are currently pursuing epidemiological investigation of this possibility.

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What are the signs of osteosarcoma?

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The signs of osteosarcoma can mimic many others. The combination of the signs presented here should help to distinguish osteosarcoma from other similar conditions, including bone metastasis. The most common presentation of osteosarcoma is painless and non-specific lower back pain that gradually worsens with time. A history of recent radiation therapy, painless swelling of the hip bone, limb-length discrepancy of the legs, and a high serum LDH level, are all suspicious signs of osteosarcoma.

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What causes osteosarcoma?

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Some data suggest that osteosarcoma is genetically or environmentally related to bone tissue. However, the heterogeneity of osteosarcoma may be related to the combination of environmental exposures early in life, or genetic vulnerabilities during somatic embryogenesis.

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What are the chances of developing osteosarcoma?

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A small number of the general population and those of the military have been diagnosed with osteosarcoma presumably by chance or exposure to a carcinogen. Although the rate of new cases of osteosarcoma was significantly higher in males than in females in all age groups, there was not a significant increase of rate of osteosarcoma occurrence in any population subgroups over any specified time interval. In conclusion, there is no good evidence that any particular activity puts an increased risk of developing osteosarcoma. To be more precise, there is no good evidence linking workplace exposures to carcinogens, recreational substances or chemicals to the risk of osteosarcoma development.

Unverified Answer

What does nivolumab usually treat?

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There are several different presentations for nivolumab. We will review the basic mechanisms of nivolumab, and its role in treating patients with various cancer types including osteosarcoma.\n\n- Cancer.net : Osteosarcoma : The Cancer Society"

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Who should consider clinical trials for osteosarcoma?

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The present research shows that parents are a major gatekeeper to participation in bone cancer pediatric clinical trials. The findings also point to the need for more rigorous clinical trial participation education and support among families.

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Does osteosarcoma run in families?

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Results from a recent clinical trial indicate neither a strong nor a weak link between osteosarcoma and occurrence of hereditary osteosarcoma in Israel. Although patients diagnosed with sporadic osteosarcoma constitute the majority, a small subgroup of patients might carry familial genetic predispositions, and further research is warranted to characterize these familial genetic mechanisms, especially the identification of tumor suppressor genes or genes that confer a more malignant disease phenotype.

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What is the average age someone gets osteosarcoma?

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Mean lifetime prevalence of osteosarcoma is 5.1 per million person-years. Although the incidence rate is higher for Caucasians than for Asians, the lifetime prevalence in the former group is similar. The age of onset is around the age of 10 (10 yr) and the time from diagnosis is 6.1+/-2 yr in Caucasians. More than 30% of osteosarcomas occur in patients 20 yr or older. Findings from a recent study are consistent with the pattern of age-specific risks seen with other solid tumours in adults. This is likely a consequence of the relatively young age at diagnosis. Age > or =5 yr at diagnosis is associated with an increased risk of metastatic disease.

Unverified Answer

Is nivolumab safe for people?

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Nivolumab was well tolerated in this study. Side effects were relatively common, and generally mild. The most common adverse effects were fatigue, headache, nausea, vomiting, itching, and rash. We anticipate that this profile will be similar to the adverse effects observed in the randomized controlled trials. Recent findings are consistent with those reported in patients with advanced cancer.

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