AV-MEL-1 for Metastatic Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic MelanomaAV-MEL-1 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination therapy for metastatic melanoma. The therapy consists of anti-PD1 monoclonal antibodies and AV-MEL-1. The study is open to patients who have never received treatment for metastatic melanoma or who have been previously treated with anti-PD-1 or with inhibitors of the BRAF/MEK pathway. The trial will enroll 14 to 20 patients.

Eligible Conditions
  • Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Vemurafenib
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Participants with Metastatic Uveal Melanoma
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Pembrolizumab Injection [Keytruda]

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
Primary Safety Endpoint: Number of grade 3-5 adverse events with AV-MEL-1 + PD-1 versus PD-1 alone

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Vemurafenib
1
Participants with Metastatic Uveal Melanoma
1
Pembrolizumab Injection [Keytruda]

Trial Design

1 Treatment Group

AV-MEL-1
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: AV-MEL-1 · No Placebo Group · Phase 1

AV-MEL-1
Drug
Experimental Group · 1 Intervention: AV-MEL-1 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Aivita Biomedical, Inc.Lead Sponsor
7 Previous Clinical Trials
1,254 Total Patients Enrolled
Robert O Dillman, MDStudy ChairAivita Biomedical, Inc.
7 Previous Clinical Trials
1,142 Total Patients Enrolled
1 Trials studying Metastatic Melanoma
56 Patients Enrolled for Metastatic Melanoma

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Presence of at least one metastatic lesion that is to be removed surgically as part of standard care (e.g.
• Diagnosis of metastatic melanoma with at least one lesion that is amenable for surgical resection per standard of care.
References

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