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Anti-metabolites

Nivolumab +/- Azacitidine for Osteosarcoma

Phase 1 & 2

Waitlist Available

Led By Patrick A. Thompson, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients receiving the following are not eligible: Corticosteroids or other immunosuppressive medications

Patients with uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post surgery

Awards & highlights

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.

Who is the study for?

This trial is for people with osteosarcoma that has come back and can be surgically removed. They should have recovered from previous treatments, not have metastasis beyond the lungs, and must agree to surgery for all tumors. Participants need normal organ function, no severe autoimmune disorders or uncontrolled illnesses, no history of certain allergies or reactions to similar drugs, and cannot be on immunosuppressants or other cancer treatments.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Nivolumab alone or combined with Azacitidine in patients whose osteosarcoma has returned but can still be operated on. The goal is to see how well these treatments work before they go through surgery to remove their tumors.See study design

What are the potential side effects?

Possible side effects include immune-related issues like inflammation in various organs, potential allergic reactions related to infusion of the drug, fatigue, changes in blood counts which could affect infection risk and organ functions. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not taking corticosteroids or other immunosuppressive medications.

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I do not have any ongoing infections or serious illnesses.

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I do not have HIV, hepatitis B, or hepatitis C.

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I have not received any anti-PD-1 therapy before.

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I have unstable chest pain.

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I have never had an autoimmune disorder.

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My cancer has not spread beyond my lungs.

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I have an irregular heartbeat.

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I have symptoms of heart failure.

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I am not currently on any experimental drugs or cancer treatments.

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I have recovered from side effects of my previous cancer treatments.

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My initial diagnosis was osteosarcoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Recommended Phase II Dose (RP2D)

Phase II: Rate of Continued Complete Remission (CR)

Secondary outcome measures

Overall Survival (OS) Rate

Percentage of Participants with Event Free Survival (EFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation, Resection, Dose ExpansionExperimental Treatment3 Interventions

Participants will receive 1 cycle of neoadjuvant Nivolumab or Nivolumab + Azacitidine, followed by surgery to render them in surgical remission. Subsequently they will continue to receive Nivolumab or Nivolumab + Azacitidine for 12 additional cycles or until recurrence, whichever occurs first. Once the recommended Phase II dose (RP2D) is identified during Phase I, the Dose Expansion Phase II will be opened at this dose level. The Phase II portion of the study will consist of a maximum 33 evaluable patients (27-30 in addition to the 3-6 enrolled at RP2D on the Phase I portion).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Nivolumab

2014

Completed Phase 3

~4750

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,471 Total Patients Enrolled

1 Trials studying Osteosarcoma

72 Patients Enrolled for Osteosarcoma

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,479 Total Patients Enrolled

1 Trials studying Osteosarcoma

5 Patients Enrolled for Osteosarcoma

Patrick A. Thompson, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

34 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03628209 — Phase 1 & 2

Osteosarcoma Research Study Groups: Dose Escalation, Resection, Dose Expansion

Osteosarcoma Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT03628209 — Phase 1 & 2

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03628209 — Phase 1 & 2

Frequently Asked Questions

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

At how many distinct sites is this research being conducted?

"This clinical trial is being run out of 25 sites across the United States. The sites are located in Aurora, Houston, Charlotte and other cities. It is helpful to select the clinic closest you to minimize travel demands if you enroll."

Answered by AI

Are there current opportunities to participate in this experiment?

"Yes, this clinical trial is still recruiting patients according to information on clinicaltrials.gov. The listing for the trial was created on October 3rd 2019 and updated November 1st 2022."

Answered by AI

Are there other examples in which surgery has been used after the primary treatment?

"Post Treatment Surgery was first researched in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. So far, a total of 408 completed trials have been conducted. Presently, 921 live trials are underway; many of these Aurora, Colorado."

Answered by AI

What is the total number of people taking part in this experiment?

"In order to carry out this experiment, 51 individuals that meet the clinical trial's inclusion criteria are required. The sponsor, Bristol-Myers Squibb, will be managing the trial from different locations which include Children's Hospital of Colorado in Aurora and University of Texas M.D. Anderson Cancer Center located in Houston."

Answered by AI

Why is Post Treatment Surgery necessary for some patients?

"One of the most popular induction chemotherapy treatments is Post Treatment Surgery, which can also help patients suffering from malignant neoplasms, leukemia, myelocytic, acute, and unresectable melanoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

2019. "Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03628209.

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