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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mohammed Milhem
Study ID
NCT07404332
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 5 Azacytidine — DRUG
    5-Azacitidine (Azacitidine) is a nucleoside analogue chemotherapy drug
  • Pembrolizumab — DRUG
    Pembrolizumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
  • Nivolumab — DRUG
    Nivolumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor
  • Cemiplimab — DRUG
    Cemiplimab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor

Study Details

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.

Key Dates

Start date
Feb 11, 2026
Status verified
May 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2031

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 5-Azacitidine Plus PD-1/PD-L1 inhibitor
    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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Mohammed Milhem, MD
[email protected]
+1 319 356 2324
Milhem

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By research site
University of Iowa Health Care· Iowa City, IA

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