A phase II study of L19IL2 injected directly into the tumor in patients with stage III/IV melanoma

• Register: EUCTR
• Last refreshed on: 26 November 2013
• Main ID: EUCTR2009-014799-23-DE
• Date of registration: 18/08/2009
• Prospective Registration: Yes
• Primary sponsor: Philogen S.p.A
• Public title: A phase II study of L19IL2 injected directly into the tumor in patients with stage III/IV melanoma
• Scientific title: A phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma - L19IL2 intratumoral
• Date of first enrolment: 04/02/2010
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014799-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Germany, Italy

Contacts

• Name: Product Manager
• Affiliation: Philogen S.p.A

• Name: Product Manager
• Affiliation: Philogen S.p.A

Key inclusion & exclusion criteria

Inclusion criteria:
• Histopathologically proven malignant melanoma
• Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a without visceral metastases
• Males or females, age > 18 years
• Either without or after one line of prior systemic treatment for metastatic disease.
• ECOG performance status < 2
• LDH < 2 x the upper limit of normal
• Life expectancy of at least 12 weeks
• Absolute neutrophil count > 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L
• Negative serum pregnancy test (for women of child-bearing potential only) at screening
• If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
• Able to provide written Informed Consent.
• Willingness and ability to comply with the scheduled visits, treatment plan,
laboratory tests and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
• Primary ocular melanoma
• Presence of visceral metastases at screening
• Evidence of active brain metastases at screening.
• History of HIV infection or infectious hepatitis B or C
• Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• Inadequately controlled cardiac arrhythmias including atrial fibrillation
• Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
• Uncontrolled hypertension
• Ischemic peripheral vascular disease (Grade IIb-IV)
• Active autoimmune disease
• History of organ allograft or stem cell transplantation
• Known history of allergy to IL2, or other intravenously administered human proteins/peptides/antibodies.
• Breast feeding female
• Growth factors or immunomodulatory agents within 7 days of the administration of study treatment
• Patients in need of systemic treatment for rapidly progressive systemic disease during study treatment and up to 2 weeks after injection of L19IL2.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Cancer- Patients with histopathologically-proven malignant melanoma with presence of measurable and injectable dermal or subcutaneous metastases either in clinical stage III or stage IV
MedDRA version: 14.0 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.0 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: L19IL2
Product Code: L19IL2
Pharmaceutical Form: Solution for injection
Other descriptive name: L19-IL2
Concentration unit: million IU million international units
Concentration type: up to
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: Safety of intratumoral administration of L19IL2
Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases)
Duration of objective response and disease control of L19IL2 treated metastases
Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases)
Duration of objective response and disease control of all metastases
Overall survival (OS)
Objective response rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
Disease control rate of all metastases at week 24 and 36 according to RECIST vs. 1.1

Main Objective: Rate of patients with complete response (CR) of L19IL2 treated metastases at week 12

Timepoint(s) of evaluation of this end point: week 12

Primary end point(s): Rate of patients with complete response(CR) of L19IL2 treated metastases at week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For objective response rates at week 12
For OS and Duration of response up to 1 year

Secondary end point(s): Safety of intratumoral administration of L19IL2
- Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases)
- Duration of objective response and disease control of L19IL2 treated metastases
- Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases)
- Duration of objective response and disease control of all metastases
- Overall survival (OS)


Objective response rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
Disease control rate of all metastases at week 24 and 36 according to RECIST vs. 1.1

Secondary ID(s)

PH-L19IL2-03/09

Source(s) of Monetary Support

Philogen S.p.A