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

NCT03743298 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CL-MEL-P01-US
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

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

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

  3 years

Study Arms (1)

AV-MEL-1

EXPERIMENTAL

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.

Drug: AV-MEL-1

Interventions

AV-MEL-1 DRUG

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.

AV-MEL-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aivita Biomedical, Inc.: lead

Study Sites (2)

Jericho Rabago

Irvine, California, 92618, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert O Dillman, MD

  Aivita Biomedical, Inc.

  STUDY CHAIR

Central Study Contacts

Jim Langford

CONTACT

949-872-2555; jim@aivitabiomedical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: April 21, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2026
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (2)