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NCT03743298 · ClinicalTrials.gov registry record · Phase 1
Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma
A Phase 1 study of Metastatic Melanoma, sponsored by Aivita Biomedical.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03743298 is a Phase 1 study of Metastatic Melanoma that is actively recruiting participants, run by Aivita Biomedical. The registered enrollment target is 20 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03743298, a Phase 1 study of Metastatic Melanoma, is actively recruiting participants, sponsored by Aivita Biomedical.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open label, single-arm, phase IB treatment study to determine the safety of administering anti-PD1 monoclonal antibodies with AV-MEL-1 and to get some suggestion of efficacy, in patients with measurable metastatic melanoma. The study is open to patients who have either never received treatment for metastatic melanoma or were previously treated with anti-PD-1 with or without anti-CTLA-4 or with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations, and are about to initiate anti-PD-1 monotherapy. The intent is to treat 14 to 20 patients with the combination of anti-PD-1 and AV-MEL-1.
Conditions Studied
Interventions
- DRUG AV-MEL-1
Study Locations (2)
California
- Jericho Rabago - Irvine
- Hoag Memorial Hospital Presbyterian - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03743298
The ClinicalTrials.gov registry entry for NCT03743298 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower). The listed sponsor is Aivita Biomedical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 1 intervention - of which AV-MEL-1 is the first listed.
NCT03743298 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03743298 about?
NCT03743298 is a clinical study titled "Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma". This is an open label, single-arm, phase IB treatment study to determine the safety of administering anti-PD1 monoclonal antibodies with AV-MEL-1 and to get some suggestion of efficacy, in patients with measurable metastatic melanoma. The study is open to patients who have either never received trea...
What is the current status of trial NCT03743298?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-04-21. Estimated completion is 2026-05.
What conditions does trial NCT03743298 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT03743298?
The interventions under investigation include: AV-MEL-1 (DRUG).
Who is sponsoring clinical trial NCT03743298?
This trial is sponsored by Aivita Biomedical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03743298 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.