What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immune-modulating agents like anti-PD1 (e.g., pembrolizumab, nivolumab) and anti-CTLA4 (e.g., ipilimumab) antibodies, are associated with several side effects. These include immune-related adverse events such as inflammation in various organ systems, which can manifest as colitis, hepatitis, endocrinopathies, and skin toxicities like rash and vitiligo. Alopecia and hair depigmentation (poliosis) are also noted. Severe side effects may require immunosuppression and discontinuation of therapy. The combination of these agents can increase the incidence and severity of these toxicities.

What prior FDA approvals exist?

The FDA has approved several immune-modulating agents for the treatment of melanoma. Pembrolizumab and nivolumab, both anti-PD1 antibodies, have been approved for their ability to enhance the immune system's response against melanoma cells. Ipilimumab, an anti-CTLA4 antibody, has also been approved for similar purposes. These agents work by inhibiting immune checkpoints, thereby boosting the body's immune response to target and destroy melanoma cells. These treatments are similar to the investigational agent ANV419, which is being studied for its potential to modulate the immune system in patients with advanced melanoma.

What other types of research exist?

Promising alternatives to ANV419 for melanoma treatment in 2024 include: 1) Combination of nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor), which has shown improved progression-free survival and overall survival in patients with advanced melanoma. 2) Nivolumab-relatlimab combination, which offers a favorable toxicity profile and improved progression-free survival over single-agent nivolumab. 3) Pembrolizumab (PD-1 inhibitor) as a monotherapy for patients with BRAF wild-type melanoma. These therapies have demonstrated significant efficacy in clinical trials and are considered effective options for enhancing the immune response against melanoma.

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Other

ANV419 + Approved Treatments for Melanoma

Phase 1 & 2

Recruiting

Research Sponsored by Anaveon AG

Eligibility Criteria Checklist

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

Must have

Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe

Have previously received anti-PD-1/L1 as monotherapy or in combination. A maximum of 2 prior lines of systemic therapy is allowed for BRAF wild-type disease and a maximum of 3 prior lines of systemic therapy is allowed for BRAFV600 positive disease

Must not have

Have evidence of active, non-infectious pneumonitis

Have a known hypersensitivity to ANV419 or to any of the excipients, such as sucrose, histidine or polysorbate 80. For combination arms only: Have hypersensitivity to pembrolizumab or ipilimumab or any of their excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ANV419 alone and with other immune-boosting drugs in adults with advanced skin cancer who have tried other treatments. The treatment aims to help the immune system fight cancer more effectively.

Who is the study for?

Adults with advanced cutaneous melanoma who've had up to 3 prior systemic therapies (depending on BRAF gene status), have measurable disease, and are in good physical condition. They must agree to contraception use and not donate sperm or eggs during the trial. Excluded are those allergic to study drugs, with uncontrolled hepatitis B/C, active autoimmune diseases requiring recent treatment, certain heart conditions, untreated brain metastases, or other serious health issues.

What is being tested?

The trial is testing ANV419 alone or combined with Pembrolizumab (anti-PD1 antibody) or Ipilimumab (anti-CTLA4 antibody) in adults with unresectable/metastatic skin cancer. It aims to assess how well these treatments work and their safety profiles.

What are the potential side effects?

Potential side effects include immune-related reactions that can affect organs like the liver or lungs, infusion-related symptoms such as fever or chills, fatigue, skin reactions at injection sites, hormonal imbalances due to immune system effects on glands like the thyroid.

Eligibility Criteria

Inclusion Criteria

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

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I will use effective birth control during and for 6 months after treatment, and won't donate eggs in this time.

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I've had up to 2 treatments for my cancer if it's BRAF wild-type, or up to 3 if it's BRAFV600 positive.

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My melanoma is at an advanced stage and cannot be surgically removed.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has worsened despite previous treatments.

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I am 18 years old or older.

Exclusion Criteria

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

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I have lung inflammation not caused by an infection.

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I am allergic to ANV419, pembrolizumab, ipilimumab, or their ingredients like sucrose.

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I have been diagnosed with melanoma in my eye or mucous membranes.

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I have had a heart attack or severe heart disease in the last 3 months.

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I stopped taking certain cancer drugs due to severe side effects not controlled by steroids.

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I have an infection that isn't getting better with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: ANV419 single agent, dose 2, Q2WExperimental Treatment1 Intervention

Group II: ANV419 single agent, dose 1, Q2WExperimental Treatment1 Intervention

Group III: ANV419 + Pembrolizumab, Q3WExperimental Treatment2 Interventions

Group IV: ANV419 + Ipilimumab, Q3WExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3070

Pembrolizumab

2017

Completed Phase 3

~3150

ANV419

2021

Completed Phase 1

~60

0 / 12Eligibility 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

Common treatments for melanoma, such as anti-PD1 antibodies (e.g., nivolumab) and anti-CTLA4 antibodies (e.g., ipilimumab), work by modulating the immune system to enhance its ability to target and destroy cancer cells. Anti-PD1 antibodies block the PD-1 pathway, which tumors exploit to evade immune detection, thereby reactivating T-cells to attack the cancer. Anti-CTLA4 antibodies inhibit the CTLA-4 checkpoint, which downregulates immune responses, thus boosting T-cell activity against melanoma. Combination therapies, like nivolumab plus ipilimumab, leverage both mechanisms to provide a more robust immune response. These treatments are crucial for melanoma patients as they can lead to prolonged survival and improved outcomes, especially in advanced stages of the disease.

Immune System Alterations in Multiple Myeloma: Molecular Mechanisms and Therapeutic Strategies to Reverse Immunosuppression.