5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMohammed Milhem
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Patients with active, untreated metastases in the central nervous system.
Patients who are pregnant or breastfeeding.
Patients who have an active infection.
Trial design
Treatments tested in this trial
- 5 Azacytidine
- Pembrolizumab
- Nivolumab
- Cemiplimab
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Mohammed Milhem
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov