Actively Recruiting
Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma
Led by Aivita Biomedical, Inc. · Updated on 2023-04-10
20
Participants Needed
2
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18
- Karnofsky Performance Status (KPS) greater than 70
- Presence of at least one metastatic lesion suitable for surgical removal as part of standard care
- Diagnosis of metastatic melanoma with at least one lesion amenable to surgical resection
- Considered appropriate for standard anti-PD-1 antibody monotherapy by managing physician
- Provided written informed consent to participate in the study
You will not qualify if you...
- Known active hepatitis B, hepatitis C, or HIV infection
- Karnofsky Performance Status (KPS) less than 70
- Known underlying cardiac disease with myocardial dysfunction requiring active treatment, unstable angina related to atherosclerotic cardiovascular disease, or treatment for arterial or venous peripheral vascular disease
- Diagnosis of any other invasive cancer or life-threatening disease expected within five years, or receiving anti-cancer therapy for cancers other than melanoma
- Active life-threatening infection or other medical condition, including active blood clotting or bleeding disorders
- Known autoimmune disease, immunodeficiency, or chronic/intermittent use of immunosuppressive therapy
- Uncontrolled brain or spinal cord metastases or active leptomingeal metastatic disease
- Received another investigational drug within 28 days before starting treatment or planning to receive another investigational drug during this study
- Known allergy to granulocyte-macrophage colony stimulating factor (GM-CSF)
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Jericho Rabago
Irvine, California, United States, 92618
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
J
Jim Langford
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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