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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006711-29
    Sponsor's Protocol Code Number:ANV419-101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-006711-29
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of ANV419 alone or in combination with approved treatment in patients with cutaneous melanoma
    A.3.2Name or abbreviated title of the trial where available
    OMNIA-1
    A.4.1Sponsor's protocol code numberANV419-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05578872
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAnaveon AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAnaveon AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnaveon AG
    B.5.2Functional name of contact pointSilvio Costanzo
    B.5.3 Address:
    B.5.3.1Street AddressHochbergerstrasse 60C
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4057
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41615218311
    B.5.6E-mailAnaveonClinicalTrials@anaveon.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameANV419
    D.3.2Product code ANV419
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANV419
    D.3.9.2Current sponsor codeANV419
    D.3.9.3Other descriptive nameFusion protein of IL-2 and humanised IgG1 monoclonal antibody against IL-2
    D.3.9.4EV Substance CodeSUB218933
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable or Metastatic Cutaneous Melanoma with prior Anti PD 1/Anti-PD-L1 Antibody Treatment
    E.1.1.1Medical condition in easily understood language
    Cutaneous Melanoma that had already been treated and is now unresectable or metastatic
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10027480
    E.1.2Term Metastatic malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective during Monotherapy Dose Expansion Phase is to evaluate the efficacy of ANV419 as monotherapy following at least 1 line of standard of care immunotherapy.

    Primary objective during Combination Dose Finding Phase is to evaluate the safety and tolerability and determine the RP2D of ANV419 in combination with pembrolizumab or with ipilimumab.

    Primary objective during Combination Dose Expansion Phase is to evaluate the efficacy of ANV419 in combination with pembrolizumab or ipilimumab following at least 1 line of standard of care immunotherapy.
    E.2.2Secondary objectives of the trial
    Monotherapy Dose Expansion: characterize the tumor response according to modified RECIST v1.1 criteria for immune-based therapeutics; expand evaluation of efficacy of ANV419; evaluate the safety of ANV419; explore immunogenicity after exposure to ANV419
    Combination Dose Finding: evaluate PK and PD of ANV419 in combination with pembrolizumab [pembro] or ipilimumab [ipi]; explore immunogenicity after exposure to ANV419 in combination with pembro or ipi; evaluate the efficacy of ANV419 in combination with pembro or ipi; evaluate clinical benefit in QoL after exposure to ANV419 in combination with pembro or ipi
    Combination Dose Expansion: expand evaluation of efficacy of ANV419 in combination with pembro or ipi; evaluate the safety of ANV419 in combination with pembro or with ipi; evaluate clinical benefit in QoL after exposure to ANV419 in combination with pembro or ipi; explore immunogenicity after exposure to ANV419 in combination with pembro or ipi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 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 and older 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 in 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;
    - 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;
    - 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.
    E.4Principal exclusion criteria
    - Have received investigational agent 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;
    - 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;
    - Have a LDH level of >=2 × upper limit of normal;
    - Have not recovered from adverse events (AEs) resulting from prior immunotherapies.
    - Have not recovered from toxicities due to a previously administered chemotherapy, targeted small molecule therapy, or radiation therapy;
    - 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, 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) (or tests positive for HIV 1 or 2 at Screening), unless certain criteria mentioned in the protocol are met
    - Have uncontrolled hepatitis B infection or hepatitis C infection;
    - Have received a live vaccine within 30 days of study Day 1
    - For combination arms only: Have received solid organ or hematopoietic stem cell transplant.
    E.5 End points
    E.5.1Primary end point(s)
    Monotherapy Dose Expansion Phase:
    ORR (CR + PR); as defined by RECIST

    Combination Dose Finding Phase:
    Incidence, frequency, and severity of AEs including the following: SAEs, TEAEs, DLTs, AESIs, irAEs, AEs leading to discontinuation of the study, and
    Changes in baseline in laboratory parameters, vital signs, ECGs, and physical examinations.

    Combination Dose Expansion Phase:
    ORR (CR + PR), as defined by RECIST
    E.5.2Secondary end point(s)
    Monotherapy Dose Expansion Phase:
    - Tumor response in terms of objective response rate (ORR: CR + PR) assessed by RECIST
    - DOR (per RECIST) and iDOR (per iRECIST[1]) measured from first response until disease progression; DCR (DCR = CR + PR + SD), iDCR (iDCR = iCR + iPR + iSD), PFS, iPFS, and OS; Median TTR; and Median iTTR
    - Incidence, frequency, and severity of AEs including SAEs; irAEs; AESIs; AEs leading to discontinuation of the study; and changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination
    - Incidence of immunogenicity as indicated by ADA

    Combination Dose Finding Phase:
    - PK endpoints in serum: CL of ANV419, Vss of ANV419, AUC of ANV419, and Cmax of ANV419
    - PD endpoints in peripheral blood: including, but not limited to, CD3, CD4, CD8, CD56, CD16, CD25, FoxP3, CD279, and CD366
    - Incidence of immunogenicity as indicated by ADA
    - ORR ( CR + PR), as defined by RECIST
    - DOR (per RECIST) and iDOR (per iRECIST[1]) measured from first response until disease progression; PFS, iPFS, and OS; DCR (DCR = CR + PR + SD), iDCR (iDCR = iCR + iPR + iSD), Median TTR; and Median iTTR.
    - Change in QoL at baseline and every 12 weeks while receiving ANV419 via QoL evaluations: EQ-5D-5L, and QLQ-C30

    Combination Dose Expansion Phase:
    - DOR (per RECIST) and iDOR (per iRECIST[1]) measured from first response until disease progression
    - DCR (DCR = CR + PR + SD), iDCR (iDCR = iCR + iPR + iSD), PFS, iPFS, and OS
    - Median TTR
    - Median iTTR
    - Incidence, frequency, and severity of AEs including the following: SAEs, irAEs, AESIs, AEs leading to discontinuation of the study, and Changes in baseline in laboratory parameters, vital signs, ECGs, and physical examination
    - Change in QoL at baseline and every 12 weeks while receiving ANV419 via QoL evaluations: EQ-5D-5L, QLQ-C30
    - Incidence of immunogenicity as indicated by ADA.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Germany
    Italy
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study (study completion) is defined as the date of the final statistical analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 130
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    For patient who still benefit from the treatment after 24 months, ongoing access to ANV419 outside of the study will be considered.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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