RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-04-21
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03743298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * Karnofsky Performance Status (KPS) of \> 70
  3. * 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)
  4. * • 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)
  5. * Considered appropriate for standard anti-PD1 antibody monotherapy by managing physician
  6. * Given written informed consent to participate in the study
  1. * Known to have active hepatitis B or C or HIV (need not be screened)
  2. * KPS of \< 70; see Appendix A
  3. * 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
  4. * 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
  5. * 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.
  6. * Known autoimmune disease, immunodeficiency, or disease process that involves the chronic or intermittent use of immunosuppressive therapy
  7. * Uncontrolled brain or spinal cord metastases or active leptomingeal metastatic disease.
  8. * Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment
  9. * Known hypersensitivity to GM-CSF
  10. * Pregnancy

Contacts and Locations

Study Contact

Jim Langford
CONTACT
949-872-2555
jim@aivitabiomedical.com

Principal Investigator

Robert O Dillman, MD
STUDY_CHAIR
Aivita Biomedical, Inc.

Study Locations (Sites)

Jericho Rabago
Irvine, California, 92618
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States

Collaborators and Investigators

Sponsor: Aivita Biomedical, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-21
Study Completion Date2026-05

Study Record Updates

Study Start Date2021-04-21
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Melanoma