Combining AV-MEL-1 with anti-PD-1 therapy for metastatic melanoma

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

This study is testing a new combination of a personalized vaccine and anti-PD-1 therapy to see if it can safely help people with advanced melanoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aivita Biomedical, Inc. (Industry-sponsored)
• Drugs / interventions: pembrolizumab, nivolumab
• Locations: 2 sites (Irvine, California and 1 other locations)
• Trial ID: NCT03743298 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm phase IB treatment evaluates the safety of combining AV-MEL-1 with anti-PD-1 monoclonal antibodies in patients with measurable metastatic melanoma. Participants will undergo leukapheresis and provide tumor samples for the development of a personalized vaccine while receiving standard anti-PD-1 therapy. The study aims to treat 14 to 20 patients who are either treatment-naive or previously treated with anti-PD-1 or BRAF/MEK inhibitors. The primary focus is on assessing safety and potential efficacy of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a diagnosis of metastatic melanoma and at least one lesion suitable for surgical resection.

Not a fit: Patients with active hepatitis B or C, HIV, or a Karnofsky Performance Status below 70 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with metastatic melanoma.

How similar studies have performed: While combining immunotherapies is a growing area of interest, this specific combination of AV-MEL-1 with anti-PD-1 therapy is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Irvine, California and 1 other locations

• Jericho Rabago — Irvine, California, United States (Recruiting)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)

Study contacts

• Study coordinator: Jim Langford

Conditions Metastatic Melanoma