Post Treatment Surgery for Osteosarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteosarcoma+4 More
Post Treatment Surgery - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective for people with a certain type of bone cancer.

Eligible Conditions
  • Osteosarcoma
  • Sarcoma

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 1 year post surgery

1 year post surgery
Overall Survival (OS) Rate
Percentage of Participants with Event Free Survival (EFS)
Phase II: Rate of Continued Complete Remission (CR)
60 days
Phase I: Recommended Phase II Dose (RP2D)

Trial Safety

Trial Design

1 Treatment Group

Dose Escalation, Resection, Dose Expansion
1 of 1
Experimental Treatment

51 Total Participants · 1 Treatment Group

Primary Treatment: Post Treatment Surgery · No Placebo Group · Phase 1 & 2

Dose Escalation, Resection, Dose ExpansionExperimental Group · 3 Interventions: Post Treatment Surgery, Nivolumab, Azacitidine · Intervention Types: Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post surgery

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
489 Previous Clinical Trials
123,319 Total Patients Enrolled
1 Trials studying Osteosarcoma
72 Patients Enrolled for Osteosarcoma
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,545 Total Patients Enrolled
1 Trials studying Osteosarcoma
42 Patients Enrolled for Osteosarcoma
Mihaela M Druta, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute, Coordinating Center
Patrick A. Thompson, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a histologic diagnosis of osteosarcoma at original diagnosis.
You must be able to understand and sign the informed consent/assent document.
Patients with metastatic disease at a site other than lung are ineligible for this study.
Patients with an isolated pulmonary recurrence of osteosarcoma can be enrolled on this study.
Patients with bilateral disease are eligible provided their disease is considered resectable
You have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to the start of protocol therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.