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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05578872

Studienbeginn:
Dezember 2022

Letztes Update:
12.02.2024

Wirkstoff:
ANV419, Pembrolizumab, Ipilimumab

Indikation (Clinical Trials):
Melanoma, Skin Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Anaveon AG

Collaborator:
-

Studienleiter

Eduard Gasal, MD
Study Director
Anaveon AG

Kontakt

Studienlocations
(3 von 25)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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 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.

Exclusion Criteria:

- 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).

- 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.

Studien-Rationale

Primary outcome:

1. Monotherapy Dose Expansion: Objective Response Rate (ORR) as defined by RECIST v1.1 (Time Frame - Day 1 up to 12 months)

2. Combination Dose Finding: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 13 months)

3. Combination Dose Finding: Recommended Phase 2 Dose of ANV419 in combination with pembrolizumab (Time Frame - Day 1 up to Day 42)

4. Combination Dose Finding: Recommended Phase 2 Dose of ANV419 in combination with ipilimumab (Time Frame - Day 1 up to Day 42)

5. Combination Dose Expansion: Objective Response Rate (ORR) as defined by RECIST, with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 12 months)

Secondary outcome:

1. Monotherapy Dose Expansion: Tumor response in terms of Objective Response Rate (ORR) assessed by iRECIST (Time Frame - Day 1 up to 12 months)

2. Monotherapy Dose Expansion: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)

3. Monotherapy Dose Expansion: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

4. Monotherapy Dose Expansion: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

5. Monotherapy Dose Expansion: Overall survival (OS) (Time Frame - Day 1 up to 13 months)

6. Monotherapy Dose Expansion: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)

7. Monotherapy Dose Expansion: Incidence, frequency, and severity of Adverse Events (Time Frame - Day 1 up to 13 months)

8. Monotherapy Dose Expansion: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)

9. Combination Dose Finding: Serum concentration of ANV419 in blood (Time Frame - Day 1 up to 12 months)

10. Combination Dose Finding: Impact of ANV419 on the expression of markers of PBMC lineage in blood (Time Frame - Day 1 up to 12 months)

11. Combination Dose Finding: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)

12. Combination Dose Finding: Objective Response Rate (ORR) as defined by RECIST, with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 12 months)

13. Combination Dose Finding: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)

14. Combination Dose Finding: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

15. Combination Dose Finding: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

16. Combination Dose Finding: Overall survival (OS) (Time Frame - Day 1 up to 13 months)

17. Combination Dose Finding: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)

18. Combination Dose Finding: Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) (Time Frame - Day 1 up to 12 months)

19. Combination Dose Finding: Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Day 1 up to 12 months)

20. Combination Dose Expansion: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 13 months)

21. Combination Dose Expansion: Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) (Time Frame - Day 1 up to 12 months)

22. Combination Dose Expansion: Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Day 1 up to 12 months)

23. Combination Dose Expansion: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)

24. Combination Dose Expansion: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)

25. Combination Dose Expansion: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

26. Combination Dose Expansion: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)

27. Combination Dose Expansion: Overall survival (OS) (Time Frame - Day 1 up to 13 months)

28. Combination Dose Expansion: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)

Studien-Arme

  • Experimental: ANV419 single agent, dose 1, Q2W
  • Experimental: ANV419 single agent, dose 2, Q2W
  • Other: ANV419 + Pembrolizumab, Q3W
  • Other: ANV419 + Ipilimumab, Q3W

Geprüfte Regime

  • ANV419:
    ANV419 administered by intravenous (IV) infusion
  • Pembrolizumab:
    Pembrolizumab administered by intravenous (IV) infusion
  • Ipilimumab:
    Ipilimumab administered by intravenous (IV) infusion

Quelle: ClinicalTrials.gov


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