NCT07404332

5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors

Phase I Study of 5-Azacitidine Plus PD-1/PD-L1 Inhibitor in Patients With PD-1/PD-L1 Refractory Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Mohammed Milhem · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I study to determine the optimal biological dose (OBD) of 5-Azacitidine in combination with PD-1/PD-L1 inhibitors in patients with tumors refractory to PD-1/PD-L1 inhibitors, for which such treatments have been approved.

Detailed description

This is a Phase I study to determine the optimal biological dose (OBD) of 5-Azacitidine in combination with PD-1/PD-L1 inhibitors in patients with tumors refractory to PD-1/PD-L1 inhibitors, for which such treatments have been approved. This Phase I study will assess 6 doses of 5-Azacitidine (5, 10, 15, 25, 50 and 75 mg/m2) in combination with a PD1/PD-L1 inhibitor. The PD1/PD-L1 inhibitor will be given at standard of care dosing approved by the FDA for this indication.

Conditions

• Solid Tumor
• Locally Advanced Solid Tumor
• Metastatic Tumor

Interventions

Type	Name	Description
DRUG	5 Azacytidine	5-Azacitidine (Azacitidine) is a nucleoside analogue chemotherapy drug
DRUG	Pembrolizumab	Pembrolizumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
DRUG	Nivolumab	Nivolumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
DRUG	Cemiplimab	Cemiplimab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor

Timeline

• Start date: 2026-02-28
• Primary completion: 2028-02-28
• Completion: 2031-02-28
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study