Phase I Study to Find the Best Dose of 5-Azacitidine with PD-1PD-L1 Inhibitors for Patients With Tumors Resistant to These Treatments

What this Trial Is About

Researchers are evaluating the best biological dose of 5-Azacitidine combined with PD-1PD-L1 inhibitors in patients whose tumors no longer respond to these immunotherapies. This Phase I study focuses on patients with locally advanced or metastatic solid tumors where PD-1 or PD-L1 treatments have already been approved. The goal is to find an optimal dose to improve treatment options for these resistant tumors. The study tests six different doses of 5-Azacitidine ranging from 5 to 75 mgm2, given together with a PD-1PD-L1 inhibitor such as Pembrolizumab, Nivolumab, or Cemiplimab. The PD-1PD-L1 inhibitors are administered at standard FDA-approved doses for this purpose. Participants receive these treatments according to the assigned dose group during the study. Participants will be monitored for side effects and tumor response using clinical and laboratory assessments, including imaging scans and blood tests. The main outcome is to measure dose-limiting toxicities and treatment responses within about one month after therapy. Longer-term outcomes like survival and tumor progression will be followed for up to five years. This process helps researchers understand the safety and effects of the drug combination over time.

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