Trials / Active Not Recruiting
Active Not RecruitingNCT03628209
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 39 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Treatment will be administered in 28 day cycles with the first cycle in the neoadjuvant setting. This will be followed by surgery to render the participant in surgical remission. Subsequently the participant will continue to receive treatment for up to 12 additional cycles or until recurrence, whichever occurs first. For participants with known bilateral lung recurrence, the nodule\[s\] in one lung should be resected, prior to the first cycle of chemotherapy. This trial was initially designed as a Phase 1/2 study; However, phase 2 will not proceed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-10-03
- Primary completion
- 2024-12-29
- Completion
- 2026-04-01
- First posted
- 2018-08-14
- Last updated
- 2026-02-05
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03628209. Inclusion in this directory is not an endorsement.