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

NCT03628209 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab in combination with azacitidine in participants with recurrent, resectable osteosarcoma

Conditions

  • Osteosarcoma
  • Osteosarcoma in Children
  • Osteosarcoma Recurrent
  • Sarcoma

Interventions

DRUG

Nivolumab

Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.

DRUG

Azacitidine

Phase I Dose Escalation - Dose level 1: NA. Dose level 2: 60 mg/m\^2. Dose level 3: 75 mg/m\^2. Phase II Expansion - Treated at recommended Phase II dose (RP2D).

PROCEDURE

Post Treatment Surgery

Resection surgery at end of Cycle 1 treatment, day 28-35.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Patrick A. Thompson, MD · University of North Carolina, Chapel Hill

  • Mihaela M Druta, MD · H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2024-12-29
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628209 on ClinicalTrials.gov