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5-Azacitidine Plus PD-1/PD-L1 Inhibitor for Refractory Solid Tumors

This study is testing a combination of 5-Azacitidine (a chemotherapy drug) with a PD-1/PD-L1 inhibitor (like Pembrolizumab, Nivolumab, or Cemiplimab, which are immune checkpoint inhibitors) for people with advanced solid tumors. These tumors have not responded to previous PD-1 or PD-L1 inhibitor treatments. The main goal is to find the best dose of 5-Azacitidine when given with these inhibitors and to see how safe this combination is. Researchers will also look at how well the treatment works. You might be able to join if you are at least 18 years old and have a solid tumor that has progressed after PD-1/PD-L1 therapy approved by the FDA.

Study design
This is a Phase I study, meaning it's an early-stage trial, and plans to include 35 participants. It will test different doses of 5-Azacitidine in combination with a standard PD-1/PD-L1 inhibitor.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects from the start of treatment through 30 days (plus or minus 7 days) after you finish therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07404332

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

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Mohammed Milhem
~35 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:5 AzacytidinePembrolizumabNivolumabCemiplimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities and responses as defined by CTCAE v5.0
Measured over Treatment initiation through 30 days +/- 7 days post completion of therapy

Conditions

Solid Tumor
Locally Advanced Solid Tumor
Metastatic Tumor

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Solid Neoplasm

NCT07404332

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa Health Care

    Iowa City, Iowastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mohammed Milhem, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Mohammed Milhem, MD
[email protected]
+1 319 356 2324
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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 (fully active, able to carry on all pre-disease performance without restriction), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work), or 2 (ambulatory and capable of self-care but unable to carry out any work activities, spending more than 50% of waking hours up and about).
Documented progression on PD1 or PD-L1 inhibitors.
Recovery from any acute toxicity associated with prior therapy to grade 1.
Renal function (creatinine level within normal institutional limit, or creatinine clearance \>15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).
Liver function (AST/ALT \<3.0 X institutional upper limit of normal OR \<5 X institutional upper limit of normal in cases of liver metastasis; total bilirubin ≤ 1.5 times upper limit of normal).
Adequate hematological lab values including:
Absolute Neutrophil Count (ANC) ≥ 1.0 X 109/L
Platelets ≥ 100X109/L
Hemoglobin ≥ 7.0 g/dL
Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from time of screening, throughout the whole duration of the drug treatment, and during the 6-month post-treatment washout period.
Patients may have previously received a hypomethylating agent, as long as it was not given in combination with ipilimumab.
Patients may have previously received ipilimumab but must have relapsed or progressed while on therapy.
Patients must have adequate archival tissue available for the purpose of downstream methylation status assessment, immunohistochemistry, RNA expression (10 slides at 5µM). If archival tissue is not available, a repeat biopsy is required.

Exclusion

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.
Patients with significant hematologic, hepatic, and renal function impairment.
Patients who are being treated for any concurrent medical condition requiring the use of systemic steroids or history of long-term use of systemic steroids.
Patients who have a history of inflammatory bowel disease or a history of symptomatic autoimmune disease.
Patients who have had any major surgical procedure or significant traumatic injury within 28 days prior to study enrollment.
Patients who have received chemotherapy, immunosuppressive agents or any investigational drug within 28 days prior to starting the study drugs.
Patients who have any underlying medical condition which, in the treating physician's opinion, will make the administration of study drugs hazardous or obscure the interpretation of adverse events.

What this trial measures

  • Incidence of dose-limiting toxicities and responses as defined by CTCAE v5.0Treatment initiation through 30 days +/- 7 days post completion of therapy

    Assess the safety and tolerability of 5-Azacitidine Plus PD-1/PD-L1 inhibitor