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

This study is testing the safety of a new treatment called AV-MEL-1 when given with anti-PD-1 therapy (like pembrolizumab or nivolumab) for people with metastatic melanoma (melanoma that has spread). AV-MEL-1 is made from your own tumor cells and immune cells. Researchers want to see how many serious side effects occur when these treatments are combined, compared to anti-PD-1 therapy alone, over three years. You might be able to join if you are over 18, have metastatic melanoma that can be surgically removed, and have a good performance status. The study is open to people who haven't been treated for metastatic melanoma before, or who have received certain prior treatments.

Study design
This is an open-label, single-arm study, meaning everyone receives the same treatment and you and your doctors will know what treatment you are getting. It aims to enroll 14 to 20 participants.
What's involved
You would provide blood and tumor samples, undergo leukapheresis (a procedure to collect white blood cells), and receive anti-PD-1 therapy. Your resected tumor tissue and collected cells will be used to create your personalized AV-MEL-1 treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint will be measured at 3 years, suggesting a follow-up period of at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03743298

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

UNKNOWN
PHASE1Ages 18+InterventionalTreatment
Aivita Biomedical, Inc.
~20 participants
Updated 2023-04-10 on ClinicalTrials.gov
What's tested:AV-MEL-1

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: Number of grade 3-5 adverse events with AV-MEL-1 + PD-1 versus PD-1 alone
Measured over 3 years

Conditions

Metastatic Melanoma

Explore related trials

Melanoma

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Robert O Dillman, MD · STUDY_CHAIR · Aivita Biomedical, Inc.

Who to contact

Jim Langford
[email protected]
949-872-2555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 18
Karnofsky Performance Status (KPS) of \> 70
Presence of at least one metastatic lesion that is to be removed surgically as part of standard care (e.g. diagnosis or diagnostic testing, mono- or oligometastatic disease, alleviation of symptoms etc)
• Diagnosis of metastatic melanoma with at least one lesion that is amenable for surgical resection per standard of care (e.g. diagnosis or diagnostic testing, mono- or oligometastatic disease, alleviation of symptoms etc)
Considered appropriate for standard anti-PD1 antibody monotherapy by managing physician
Given written informed consent to participate in the study

Exclusion

Known to have active hepatitis B or C or HIV (need not be screened)
KPS of \< 70; see Appendix A
Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than melanoma
Active infection that could be eminently life-threatening or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
Known autoimmune disease, immunodeficiency, or disease process that involves the chronic or intermittent use of immunosuppressive therapy
Uncontrolled brain or spinal cord metastases or active leptomingeal metastatic disease.
Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment
Known hypersensitivity to GM-CSF
Pregnancy

What this trial measures

  • Primary Safety Endpoint: Number of grade 3-5 adverse events with AV-MEL-1 + PD-1 versus PD-1 alone3 years

    Determine whether combining AV-MEL-1 with anti-PD-1 is associated with increased risk as defined by AEs per NCI common toxicity criteria