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Checkpoint Inhibitor

A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab for Melanoma

Phase 1 & 2
Waitlist Available
Led By Jason Chesney, MD, PhD
Research Sponsored by Angimmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, then at least every 3 months post treatment (maximum 36 months)
Awards & highlights

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.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, then at least every 3 months post treatment (maximum 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months, then at least every 3 months post treatment (maximum 36 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Response measure is the change in Progression Free Survival time (PFS).
Secondary outcome measures
Changes in Clinical Response Rates
Overall Survival, OS
Tolerability to Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: A-dmDT390-bisFv(UCHT1)/Radiation/PembrolizumabExperimental Treatment3 Interventions
A-dmDT390-bisFv(UCHT1): 2.5 µg/kg 2x x 4 days, Ionizing Radiation: single treatment on day five of 14-24 Gy to a tumor, Pembrolizumab: 2 mg/kg IV every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
A-dmDT390-bisFv(UCHT1)
Not yet FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Angimmune LLCLead Sponsor
3 Previous Clinical Trials
196 Total Patients Enrolled
1 Trials studying Melanoma
2 Patients Enrolled for Melanoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,155 Total Patients Enrolled
6 Trials studying Melanoma
313 Patients Enrolled for Melanoma
Jason Chesney, MD, PhDPrincipal InvestigatorJames Graham Brown Cancer
3 Previous Clinical Trials
98 Total Patients Enrolled
3 Trials studying Melanoma
98 Patients Enrolled for Melanoma
~7 spots leftby Sep 2025
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