Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT03628209

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

A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

Sponsor: Bristol-Myers Squibb

Conditions Osteosarcoma Osteosarcoma Recurrent Osteosarcoma in Children Sarcoma

Interventions Azacitidine Nivolumab Post Treatment Surgery

Updated 35 times since 2018 Last updated: Feb 3, 2026 Started: Oct 3, 2019 Primary completion: Dec 29, 2024 Completion: Apr 30, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Osteosarcoma and Osteosarcoma Recurrent and is currently ongoing. Bristol-Myers Squibb leads this study, which shows 35 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

35 versions recorded

Feb 2026 — Present [monthly]

Active Not Recruiting PHASE1
Nov 2025 — Feb 2026 [monthly]

Active Not Recruiting PHASE1
Sep 2025 — Nov 2025 [monthly]

Active Not Recruiting PHASE1
May 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE1

Phase: PHASE1/PHASE2 → PHASE1
Feb 2025 — May 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2

▶ Show 30 earlier versions

Jan 2025 — Feb 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2024 — Jan 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Mar 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Nov 2023 — Mar 2024 [monthly]

Recruiting PHASE1_PHASE2
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE1_PHASE2
May 2023 — Oct 2023 [monthly]

Recruiting PHASE1_PHASE2
Feb 2023 — May 2023 [monthly]

Recruiting PHASE1_PHASE2
Dec 2022 — Feb 2023 [monthly]

Recruiting PHASE1_PHASE2
Sep 2022 — Dec 2022 [monthly]

Recruiting PHASE1_PHASE2
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE1_PHASE2
Apr 2022 — Jun 2022 [monthly]

Recruiting PHASE1_PHASE2
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE1_PHASE2
Oct 2021 — Mar 2022 [monthly]

Recruiting PHASE1_PHASE2
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE1_PHASE2
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE1_PHASE2
May 2021 — Jun 2021 [monthly]

Recruiting PHASE1_PHASE2
Apr 2021 — May 2021 [monthly]

Recruiting PHASE1_PHASE2
Feb 2021 — Apr 2021 [monthly]

Recruiting PHASE1_PHASE2
Jan 2021 — Feb 2021 [monthly]

Recruiting PHASE1_PHASE2
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Oct 2020 — Dec 2020 [monthly]

Recruiting PHASE1_PHASE2
Jun 2020 — Oct 2020 [monthly]

Recruiting PHASE1_PHASE2
Jan 2020 — Jun 2020 [monthly]

Recruiting PHASE1_PHASE2
Oct 2019 — Jan 2020 [monthly]

Recruiting PHASE1_PHASE2
Aug 2019 — Oct 2019 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
May 2019 — Aug 2019 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Mar 2019 — May 2019 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Dec 2018 — Mar 2019 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Sep 2018 — Dec 2018 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bristol-Myers Squibb
H. Lee Moffitt Cancer Center and Research Institute

Data source: H. Lee Moffitt Cancer Center and Research Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Baltimore, United States , Birmingham, United States , Buffalo, United States , Chapel Hill, United States , Charlotte, United States , Cleveland, United States , Columbus, United States , Dallas, United States , Durham, United States and 12 more locations