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

ConditionsSolid TumorLocally Advanced Solid TumorMetastatic Tumor
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: 5-Azacitidine Plus PD-1/PD-L1 inhibitorExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities and responses as defined by CTCAE v5.0

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

Time frame
Treatment initiation through 30 days +/- 7 days post completion of therapy

Secondary outcomes

1

Proportion of participants with a complete response (CR)

The proportion of patients with a pathologic complete response, defined as disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level

Time frame
Treatment initiation through five years
2

Proportion of participants with a partial response (PR)

At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

Time frame
Treatment initiation through five years
3

Overall Survival (OS)

Time from study treatment initiation to death due to any cause

Time frame
Treatment initiation through five years
4

Progression Free Survival (PFS)

Time from study treatment initiation to disease progression or death due to any cause

Time frame
Treatment initiation through five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohammed Milhem

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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