Phase I Study of 5-Azacitidine Plus PD-1/PD-L1 Inhibitor in Patients With PD-1/PD-L1 Refractory Tumors
Mohammed Milhem
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.
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written and voluntary informed consent. * At least 18 years of age or older. * Histologically and radiologically confirmed locally advanced or metastatic unresectable solid tumor malignancy for which PD-1 or PD-L1 therapy is already approved by the FDA. Locally advanced is defined as unresectable in the opinion of the treating physician. A repeat biopsy is required if previous biopsy tissue is unavailable. * At least one Response Evaluation Criteria in Solid Tumors (RECIST 1.1) - defined target lesion. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 (…
Interventions
- Drug5 Azacytidine
5-Azacitidine (Azacitidine) is a nucleoside analogue chemotherapy drug
- DrugPembrolizumab
Pembrolizumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
- DrugNivolumab
Nivolumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
- DrugCemiplimab
Cemiplimab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
Location
- University of Iowa Health CareIowa City, Iowa