MedTrace Logo

Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

NCT04453046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-12-20

No results posted yet for this study

Summary

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab (Keytruda) in the front line setting, in patients with advanced and/or metastatic squamous cell carcinoma of the head and neck.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DEVICE

Hemopurifier

Two Hemopurifier treatments on Day 1 and Day 21

DRUG

Pembrolizumab 200mg IV

Pembrolizumab 200mg IV will be administered every 21 days. One cycle is 21 days. All patients will be treated with Pembrolizumab for up to 34 cycles

Sponsors & Collaborators

  • Aethlon Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Dan Zandberg, MD · UPMC Hillman Cancer Center

  • Steven P. LaRosa, M.D. · Aethlon Medical Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2022-11-14
Completion
2022-11-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04453046 on ClinicalTrials.gov