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Melanoma (Skin)Phase 1/2NCT05578872

A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).

A Phase 1/2 study testing ANV419 in people with Melanoma (Skin) and Cutaneous Melanoma, run by Anaveon AG at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin), Cutaneous Melanoma, Adult Disease
What is being tested?
ANV419
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
25 sitesin 5 countries
Study dates
16 Dec 2022to 1 Aug 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must provide written informed consent for the study;
  • Must be able to comply with the Protocol as judged by the Investigator;
  • Are ≥18 years of age on day of signing informed consent;
  • Have histologically confirmed Stage 3 (unresectable) or Stage 4 (metastatic) CM, as per the American Joint Committee on Cancer staging system, eighth edition;
  • Have documented radiological progression on prior systemic therapy;
  • 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;
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  • Have measurable disease based on RECIST;
  • Have a performance status of 0 or 1 on the ECOG Performance Status;
  • Have adequate organ functions as defined per protocol;
  • Female patients of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative (urine or serum) pregnancy test within 72 hours prior to study Day 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and must be negative for the patient to be eligible;
  • 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; and
  • Male patients with partners of childbearing potential must agree to use highly effective methods of contraception and barrier contraception (condom) during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate sperm during the same timeframe.

Who cannot join

  • Have received investigational agent (including investigational device) within 4 weeks or an interval of 5 half-lives of the respective investigational agent prior to study Day 1, whichever is longer, with the exclusion of an anti-PD-1/anti-PD-L1 antibody given as either a single agent or non-CTLA-4 antibody containing combination (eg, anti-lymphocyte-activation gene 3 antibody);
  • 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;
  • For combination arms only: Have previously discontinued ipilimumab, pembrolizumab or any other PD-1/PD-L1 inhibitors due to unacceptable drug-related toxicity (defined as toxicities that required second line immunosuppression, ie, not controlled by steroids alone);
  • Have an LDH level of ≥2 × upper limit of normal;
  • Have not recovered (ie, ≤Grade 1 or at baseline with the exception of alopecia or fatigue [up to Grade 2 allowed]) from AEs resulting from prior immunotherapies. Patients who have autoimmune AEs controlled by replacement therapy (ie, hypothyroidism) due to previous treatment are eligible provided replacement therapy has been initiated and toxicity has returned to Grade 1;
  • Have not recovered (ie, ≤Grade 1 or at baseline) from toxicities due to a previously administered prior chemotherapy, targeted small molecule therapy, or radiation therapy; Note: If the patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug. Major surgery is defined as any surgery requiring entrance into a body cavity (eg, chest, abdomen, or brain), organ removal, normal anatomy alteration, or joint replacement. Minor surgery is defined as any surgery in which skin, mucosa, or connective tissue sections are altered (eg, biopsy, cataract, endoscopic procedures, etc).
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  • Have been diagnosed with uveal/ocular or mucosal melanoma;
  • Have a known additional malignancy (including all in-situ carcinoma) that is progressing or required active treatment within ≤2 years prior to enrollment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer or patients who completed cancer-directed therapy and have no evidence of disease;
  • Have active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and any neurologic symptoms have returned to baseline or have been stable for at least 7 days), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study drug. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability;
  • Have a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days prior to study Day 1;
  • Are receiving systemic steroid >10 mg of prednisone daily or equivalent or any other immunosuppressive medication at any dose level. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or inhaled medications) are acceptable;
  • Have an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment;
  • Have evidence of active, non-infectious pneumonitis;
  • Have active (measurable) and uncontrolled (unresponsive to current therapy) infectious disease (bacterial, fungal, viral, or protozoic);
  • Have a history of an acute coronary event (eg, myocardial infarction) within 3 months prior to study Day 1, uncontrolled and symptomatic coronary artery disease or congestive heart failure New York Heart Association Class III/IV;
  • Have an average QTcF interval >470 msec at Screening;
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or it is not in the best interest of the patient to participate, in the opinion of the treating Investigator;
  • Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;
  • Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 6 months after the last dose of study drug;
  • Are known to be human immunodeficiency virus (HIV) positive (or tests positive for HIV 1 or 2 at Screening), unless the following criteria are met: CD4+ lymphocyte count >350 µL; Had no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months; Have been on established anti-retroviral therapy for at least 4 weeks; and Have an HIV viral load of <400 copies/mL prior to study Day 1. Note: Patients on strong cytochrome P450 (CYP)3A4 inhibitors or strong CYP3A4 inducers must be switched to an alternate effective anti-retroviral therapy regimen prior to study treatment or are excluded if regimen prior to study Day 1 cannot be altered.
  • Have uncontrolled hepatitis B infection or hepatitis C infection; or Note: Patients with hepatitis B (positive hepatitis B surface antigen) who have controlled infection (serum hepatitis B virus DNA by polymerase chain reaction that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of hepatitis B virus DNA. Note: Patients with hepatitis C (positive hepatitis C virus antibody) who have controlled infection (undetectable hepatitis C virus RNA by polymerase chain reaction either spontaneously or in response to a successful prior course of anti-hepatitis C virus therapy) are permitted.
  • Have received a live vaccine within 30 days of study Day 1; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • For combination arms only: Have received solid organ or hematopoietic stem cell transplant.

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

United States9 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • HealthPartners Institute

    Bloomington, Minnesota, 21109A

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Colorado Denver

    Denver, Colorado, 80045

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • University of California San Diego

    La Jolla, California, 92093-0990

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California San Francisco

    San Francisco, California, 94143-1209

Other trials in United States

France6 sites

  • Centre Georges François Leclerc

    Dijon

  • Centre Hospitalier Universitaire de Lille

    Lille, 59037

  • CHU de Nantes

    Nantes

  • AP-HP Hopital Saint-Louis

    Paris

  • Gustave Roussy

    Paris

  • CHU de Poitiers

    Poitiers

Other trials in France

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona

  • Centro Oncológico MD Anderson International España

    Madrid, 28033

  • Hospital Universitario 12 de Octubre

    Madrid

  • Clínica Universidad de Navarra

    Pamplona

  • Universitary Hospital Virgen Macarena

    Seville

Other trials in Spain

Italy3 sites

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedaliero Universitaria Senese

    Siena, 53100

Other trials in Italy

Germany2 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsmedizin der Johannes Gutenberg, Universität Mainz

    Mainz, 55131

Other trials in Germany

About this study

Official title: A Phase 1/2 Study of ANV419 as Monotherapy or in Combination With Anti-PD-1 or Anti-CTLA-4 Antibody Following Anti-PD-1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma (OMNIA-1)

The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419 in monotherapy and Parts 2 and 3 to evaluate ANV419 in combination with anti-PD1 antibody or anti-CTLA4 antibody. Parts 2 and 3 were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met at the interim analysis of Part 1.

Read the detailed description

The purpose of this multi-site, open-label, randomized, parallel arm, Phase 1/2 adaptive study is to evaluate the efficacy and safety of ANV419 as a monotherapy and in combination with anti-PD1 antibody or anti-CTLA4 antibody in patients aged 18 years or older with advanced Cutaneous Melanoma who have previously been treated with an anti-PD-1/anti-PD-L1 antibody.

Being tested
ANV419
Keywords
IL-2, ANV419, Cancer, Melanoma, OMNIA, Cutaneous, Metastatic, Anti-PD1
Medical subject headings
Melanoma, Disease, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANV419Drug

    ANV419 administered by intravenous (IV) infusion

Study groups in NCT05578872
Study groupRoleWhat they receive
ANV419 single agent, low doseExperimentalNot described
Receives: Drug: ANV419
ANV419 single agent, high doseExperimentalNot described
Receives: Drug: ANV419

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1

    Proportion of participants with a complete response (CR) or partial response (PR) to treatment as defined by RECIST v1.1 (ORR = CR + PR)

    Measured: Day 1 up to 12 months

Secondary outcomes (7)

  1. Monotherapy Dose Expansion: Duration of Response (DOR) According to RECIST v1.1

    Time from first time measurement criteria are met for complete response (CR) or (PR) until the progressive disease or death.

    Measured: Day 1 up to 12 months

  2. Monotherapy Dose Expansion: Disease Control Rate (DCR) According to RECIST v1.1

    Percentage of participants who have achieved Complete Response (CR), Partial Response (PR) and Stable Disease (SD).

    Measured: Day 1 up to 12 months

  3. Monotherapy Dose Expansion: Progression-free Survival (PFS) According to RECIST v1.1

    Length of time participants lived with the disease without progressing (PD)

    Measured: Day 1 up to 12 months

  4. Monotherapy Dose Expansion: Overall Survival (OS) Rate

    Proportion of participants who are alive at 6 months. This is an estimation based on Kaplan-Meier method.

    Measured: Day 1 up to 6 months

  5. Monotherapy Dose Expansion: Frequency of Treatment-Emergent Adverse Events (TEAEs)

    Number of participants with TEAEs.

    Measured: Day 1 through study completion, an average of 3.7 months and a maximum of 14 months.

  6. Monotherapy Dose Expansion: Severity of TEAEs

    Number of participants with TEAEs Grade 3 or more.

    Measured: Day 1 through study completion, an average of 3.7 months and a maximum of 14 months.

  7. Monotherapy Dose Expansion: Prevalence of Specific Anti-ANV419 Antibodies (ADA) in Blood

    Number of patients with positive ADA at baseline and end of study.

    Measured: Day 1 through study completion, an average of 3.7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start16 Dec 2022
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05578872
Sponsor's protocol ID
ANV419-101
Status last verified
Aug 2025
First submitted
11 Oct 2022
Last updated
26 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ANV419 in people with Melanoma (Skin) and Cutaneous Melanoma, run by Anaveon AG at 25 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, France, Spain, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1 (time frame: Day 1 up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05578872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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