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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03628209
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Osteosarcoma
  • Osteosarcoma Recurrent
  • Osteosarcoma in Children
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.
  • Azacitidine — DRUG
    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).
  • Post Treatment Surgery — PROCEDURE
    Resection surgery at end of Cycle 1 treatment, day 28-35.

Study Details

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

Key Dates

Start date
Oct 3, 2019
Status verified
Feb 2026
Primary completion
Dec 29, 2024
Completion
Apr 30, 2026

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation, Resection, Dose Expansion
    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).

Primary Outcome Measure

Phase I: Recommended Phase II Dose (RP2D) [ Time Frame: 60 days ]

Locations (22)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90027-
Children's Hospital of ColoradoAuroraColorado80045-
Connecticut Children's Medical CenterHartfordConnecticut06106-
Alfred I DuPont Hospital for ChildrenWilmingtonDelaware19803-
Shand's Hospital for Children at the University of FloridaGainesvilleFlorida32610-
Nemours Children's HospitalJacksonvilleFlorida32207-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Nemours Children's ClinicOrlandoFlorida32806-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
H. Lee Moffitt Cancer Center and Research Institute, Coordinating CenterTampaFlorida33612-
University of Kentucky, Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University, Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203-
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Carolina Medical Center, Levine Cancer InstituteCharlotteNorth Carolina28203-
Duke HealthDurhamNorth Carolina27708-
Cleveland ClinicClevelandOhio44195-
Nationwide Children's HospitalColumbusOhio43205-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALChildren's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center· Los Angeles, CAChildren's Hospital of Colorado· Aurora, COConnecticut Children's Medical Center· Hartford, CTAlfred I DuPont Hospital for Children· Wilmington, DEShand's Hospital for Children at the University of Florida· Gainesville, FL

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