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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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. These will be patients who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations, and are about to initiate anti-PD1 monotherapy. The intent is to treat 14 to 20 patients with the combination of anti-PD-1 and AV-MEL-1.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aivita Biomedical, Inc.

Criteria

Inclusion Criteria:

• Age > 18

• Karnofsky Performance Status (KPS) of > 70

• Histologic diagnosis of metastatic melanoma

• 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)

• 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 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

• Previous anti-cancer treatment for melanoma, other than BRAF/MEK inhibittion.

• Known hypersensitivity to GM-CSF

• Pregnancy