Study of ANV419 Alone or with Other Approved Treatments for Advanced Skin Melanoma (OMNIA-1)

Sponsor: Anaveon AG

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05578872

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, ANV419, either by itself or combined with other approved treatments, in adults with advanced skin melanoma that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to evaluate how well ANV419 works and how safe it is when used alone or with other treatments like anti-PD1 or anti-CTLA4 antibodies in adults with advanced skin melanoma. Participants must have previously been treated with anti-PD-1 or anti-PD-L1 antibodies.

Description

This study is being conducted at multiple locations and involves testing ANV419, a new drug, either on its own or in combination with other approved treatments for advanced skin melanoma. The study is open to adults aged 18 and older who have melanoma that cannot be removed by surgery or has spread to other parts of the body. Participants must have previously received treatment with anti-PD-1 or anti-PD-L1 antibodies. The study will assess the effectiveness and safety of ANV419 in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be able to follow the study requirements.
  • Aged 18 years or older.
  • Have advanced skin melanoma that cannot be surgically removed or has spread.
  • Have shown disease progression after previous treatments.
  • Have received anti-PD-1 or anti-PD-L1 treatments before.
  • Have measurable disease based on specific criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function as per study requirements.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception during and for 6 months after treatment.
  • Men with partners of childbearing potential must agree to use effective contraception during and for 6 months after treatment.

Exclusion Criteria

  • Have used an investigational drug or device within a certain period before starting the study.
  • Have allergies to ANV419 or its components, or to pembrolizumab or ipilimumab for combination treatments.
  • Have discontinued certain treatments due to severe side effects.
  • Have high levels of LDH in the blood.
  • Have not recovered from side effects of previous treatments.
  • Have been diagnosed with certain types of melanoma or other cancers requiring treatment within the last 2 years.
  • Have active brain metastases or certain brain conditions.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Are taking systemic steroids or other immunosuppressive medications.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have active lung inflammation or uncontrolled infections.
  • Have had a recent heart attack or severe heart disease.
  • Have a prolonged QT interval on an ECG.
  • Have any condition that might interfere with the study.
  • Have psychiatric or substance abuse disorders affecting study participation.
  • Are pregnant or breastfeeding.
  • Are HIV positive unless certain conditions are met.
  • Have uncontrolled hepatitis B or C infections.
  • Have received a live vaccine recently.
  • Have had a solid organ or stem cell transplant for combination treatments.

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