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Anti-metabolites

Nivolumab +/- Azacitidine for Osteosarcoma

Phase 1 & 2

Waitlist Available

Led By Mihaela M Druta, 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

Must not have

Concomitant Medications: Patients receiving the following are not eligible: Corticosteroids or other immunosuppressive medications, Patients who are currently receiving other investigational agents or other anti-cancer therapy

Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as outlined in study protocol documentation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking steroids, immunosuppressants, or any cancer treatments.

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I am using two forms of birth control, one highly effective and another as required.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Recommended Phase II Dose (RP2D)

Phase II: Rate of Continued Complete Remission (CR)

Secondary study objectives

Overall Survival (OS) Rate

Percentage of Participants with Event Free Survival (EFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nivolumab

2014

Completed Phase 3

~5220

Azacitidine

2012

Completed Phase 3

~1440