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RECRUITING
NCT03743298
PHASE1

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma

Sponsor: Aivita Biomedical, Inc.

View on ClinicalTrials.gov

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.

Official title: Phase 1B Trial of AV-MEL-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Antigens) With Anti-PD-1 Checkpoint Inhibitors in Metastatic Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-04-21

Completion Date

2026-05

Last Updated

2023-04-10

Healthy Volunteers

No

Interventions

DRUG

AV-MEL-1

AV-MEL-1: Autologous dendritic cells loaded with autologous tumor antigens (ATA) from a short-term cell culture of autologous tumor cells. AV-MEL-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.

Locations (2)

Jericho Rabago

Irvine, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States