5-Azacitidine + PD-1/PD-L1 Inhibitors for Cancer

Overseen By Mohammed Milhem, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mohammed Milhem

Must be taking: PD-1/PD-L1 inhibitors

Must not be taking: Systemic steroids

Disqualifiers: Active CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Mohammed Milhem, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that have stopped responding to PD-1/PD-L1 inhibitors approved by the FDA. Participants must be able to perform daily activities, have a target lesion defined by RECIST 1.1, and recovered from previous therapy side effects. They need normal kidney and liver function tests and an adequate neutrophil count.

Inclusion Criteria

I have signed a consent form to participate.

My liver tests are within the required limits, even with liver metastasis.

My cancer has worsened despite treatment with PD1 or PD-L1 inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5-Azacitidine in combination with a PD-1/PD-L1 inhibitor to determine the optimal biological dose

6 weeks

Weekly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• 5-Azacitidine
• Cemiplimab
• Nivolumab
• Pembrolizumab

Trial Overview

The study aims to find the best dose of 5-Azacitidine when used with PD-1/PD-L1 inhibitors (Nivolumab, Cemiplimab, Pembrolizumab) in patients whose tumors no longer respond to these inhibitors. It's an early-phase trial focusing on dosage optimization.

How Is the Trial Designed?

Group I: 5-Azacitidine Plus PD-1/PD-L1 inhibitor Experimental Treatment 4 Interventions

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. Inhibitors approved for study indications include Pembrolizumab, Nivolumab, and Cemiplimab.

Who Is Running the Clinical Trial?

Mohammed Milhem

Lead Sponsor

Trials

9

Recruited

240+