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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
All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions >= 1.5 cm that would not occupy the same radiation field. Patients must be treatment naïve except for treatment with BRAF inhibitors. Patients with melanoma must have an anti-DT titer of <20 μg/ml. Patients with brain metastasis and ocular and mucosal lesions can be enrolled at the discretion of the PI providing that other non-brain and non-ocular metastatic lesions are available as targets for radiation therapy
Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior therapy with BRAF inhibitors. Adequate bone marrow function will be defined as ANC >750 uL, WBC >1000 uL, platelets >60,000 uL and Hb > 9g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, then at least every 3 months post treatment (maximum 36 months)
Awards & highlights
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.
Eligible Conditions
- Melanoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months, then at least every 3 months post treatment (maximum 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, then at least every 3 months post treatment (maximum 36 months)
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
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