Recruiting
Phase 1

Anti-PD-1 & AV-MEL-1

Sponsor:

Aivita Biomedical, Inc.

Code:

NCT03743298

Conditions

Metastatic Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AV-MEL-1

Study Details

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

Study ID

NCT03743298

Start date

Apr 21, 2021

Status verified date

Apr, 2023

Completion date

May, 2026

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jim Langford

949-872-2555jim@aivitabiomedical.com

Locations

Jericho Rabago

Recruiting

Irvine, California, United States, 92618

Contacts

Jericho Rabago, BSN, RN

949-764-6796jericho.rabago@hoag.org

Principal Investigator:

Chaitali S Nangia, MD

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Jericho Rabago, BSN, RN

949-764-6796jericho.rabago@hoag.org

Principal Investigator:

Chaitali S Nangia, MD

More Information

Sponsor

Aivita Biomedical, Inc.

Last update posted

Apr 10, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aivita Biomedical, Inc. on 2023-04-10.