What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immune checkpoint inhibitors like pembrolizumab and nivolumab, are associated with a range of immune-related adverse events. These include skin reactions (rash, pruritus), endocrine disorders (hypothyroidism, adrenal insufficiency), gastrointestinal issues (colitis, diarrhea), and less commonly, severe conditions like pneumonitis and hepatitis. Combining these therapies with other agents, such as ipilimumab, can increase the frequency and severity of these side effects. AV-MEL-1, an investigational immunotherapy, may have similar immune-related side effects, though specific data are limited.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of melanoma, particularly anti-PD1 monoclonal antibodies such as pembrolizumab and nivolumab. These drugs work by blocking the PD-1 pathway, thereby enhancing the immune system's ability to fight cancer. Additionally, combinations of these inhibitors with other agents, such as ipilimumab (an anti-CTLA-4 antibody), have also been approved. These treatments have shown significant efficacy in improving overall survival and response rates in patients with advanced melanoma.

What other types of research exist?

Promising novel alternatives for melanoma treatment in 2024 include combination therapies involving CTLA-4 inhibitors (e.g., ipilimumab) and novel immune checkpoints like CEACAM1. Additionally, personalized antibody treatments and therapies targeting other immune checkpoints or molecular pathways are under investigation.

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AV-MEL-1 + Anti-PD-1 for Melanoma

Phase 1

Recruiting

Research Sponsored by Aivita Biomedical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Known autoimmune disease, immunodeficiency, or disease process that involves the chronic or intermittent use of immunosuppressive therapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of an immune-boosting drug and a personalized vaccine in patients with advanced melanoma. The goal is to see if this approach is safe and effective in helping the immune system fight cancer. Ipilimumab, an immune-boosting drug, has been shown to improve survival in advanced melanoma patients, but only about 20% experience long-term benefits.

Who is the study for?

This trial is for adults over 18 with metastatic melanoma, who are fit enough to undergo surgery for at least one lesion and can start anti-PD-1 therapy. They should have a good performance status (able to care for themselves) and not be on any investigational drugs or have serious heart disease, uncontrolled brain metastases, active hepatitis B/C or HIV, another life-threatening cancer, severe infections, bleeding disorders, autoimmune diseases or need immunosuppressive therapy.

What is being tested?

The study tests the safety of AV-MEL-1 combined with anti-PD-1 antibodies in patients with metastatic melanoma. It's an open-label phase IB trial aiming to treat 14-20 patients. Participants may be new to treatment or previously treated with specific inhibitors due to BRAF600E/K mutations.

What are the potential side effects?

Potential side effects include those commonly associated with immune therapies such as inflammation in various organs (like colitis), fatigue, skin reactions (rash), hormonal gland issues (thyroid problems), and possibly infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancer spread that will be surgically removed.

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I have metastatic melanoma with at least one tumor that can be surgically removed.

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I am mostly independent and can care for myself.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease or need regular immunosuppressive therapy.

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I do not have any life-threatening infections or conditions like uncontrolled bleeding.

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I do not have uncontrolled brain or spinal cord cancer spread.

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I do not have another life-threatening cancer or disease expected to be fatal within 5 years.

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My health severely limits my daily activities.

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I am being treated for heart disease or unstable chest pain.

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I have active hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AV-MEL-1Experimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as Anti-PD1 monoclonal antibodies (e.g., pembrolizumab and nivolumab), work by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, these drugs enhance the body's immune response against melanoma cells. AV-MEL-1, an investigational immunotherapy, likely aims to stimulate the immune system to recognize and attack melanoma cells more effectively. These treatments are crucial for melanoma patients as they offer a targeted approach to boost the immune system's ability to fight cancer, potentially leading to better outcomes and prolonged survival.