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

NCT07404332 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-11

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumor
  • Locally Advanced Solid Tumor
  • Metastatic Tumor

Interventions

DRUG

Nivolumab

Nivolumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor

DRUG

Cemiplimab

Cemiplimab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor

DRUG

5 Azacytidine

5-Azacitidine (Azacitidine) is a nucleoside analogue chemotherapy drug

DRUG

Pembrolizumab

Pembrolizumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor

Sponsors & Collaborators

  • Mohammed Milhem

    lead OTHER

Principal Investigators

  • Mohammed Milhem, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-02-28
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07404332 on ClinicalTrials.gov