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

NCT05578872 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ANV419-101
• Study Type: interventional
• Target: 29
• Locations: 5 countries
• Sites: 25

Brief 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. 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.

Conditions

Melanoma (Skin); Cutaneous Melanoma; Adult Disease; Advanced Solid Tumor; Metastatic Melanoma

Keywords

IL-2; ANV419; Cancer; Melanoma; OMNIA; Cutaneous; Metastatic; Anti-PD1

Outcome Measures

Primary Outcomes (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)

  Day 1 up to 12 months

Secondary Outcomes (7)

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

  Day 1 up to 12 months

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

  Day 1 up to 12 months

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

  Day 1 up to 12 months

• Monotherapy Dose Expansion: Overall Survival (OS) Rate

  Day 1 up to 6 months

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

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

Study Arms (2)

ANV419 single agent, low dose

EXPERIMENTAL

Drug: ANV419

ANV419 single agent, high dose

EXPERIMENTAL

Drug: ANV419

Interventions

ANV419 DRUG

ANV419 administered by intravenous (IV) infusion

ANV419 single agent, high dose; ANV419 single agent, low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Anaveon AG: lead

Study Sites (25)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92093-0990, United States

Location

University of California San Francisco

San Francisco, California, 94143-1209, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

HealthPartners Institute

Bloomington, Minnesota, 21109A, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

Location

CHU de Nantes

Nantes, France

Location

AP-HP Hopital Saint-Louis

Paris, France

Location

Gustave Roussy

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsmedizin der Johannes Gutenberg, Universität Mainz

Mainz, 55131, Germany

Location

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Senese

Siena, 53100, Italy

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Centro Oncológico MD Anderson International España

Madrid, 28033, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Universitary Hospital Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Melanoma; Disease; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Results Point of Contact

• Title: Medical Director, MD
• Organization: Anaveon AG

anaveonclinicaltrials@anaveon.com

+41615218383

Study Officials

• Eduard Gasal, MD

  Anaveon AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: December 16, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); DE (2); FR (6); US (9); ES (5)