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A-dmDT390-bisFv(UCHT1) Fusion Protein With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma

NCT02990416 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-12-13

No results posted yet for this study

Summary

This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.

Conditions

  • Stage IV Melanoma

Interventions

BIOLOGICAL

A-dmDT390-bisFv(UCHT1)

anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)

BIOLOGICAL

Pembrolizumab

A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.

RADIATION

Ionizing Radiation

Electromagnetic or corpuscular radiation capable of producing ions, directly or indirectly, in its passage through matter.

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • Angimmune LLC

    lead INDUSTRY

Principal Investigators

  • Jason Chesney, MD, PhD · James Graham Brown Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02990416 on ClinicalTrials.gov