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Malignant MelanomaPhase 2NCT01253096

Intratumoral Application of L19IL2 in Patients With Malignant Melanoma

A Phase 2 study testing Intratumoral injections of L19IL2 in people with Malignant Melanoma, run by Philogen S.p.A. at 3 sites in 2 countries.

Completed

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

Official record
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Trial summary

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Intratumoral injections of L19IL2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesin 2 countries
Study dates
Apr 2010to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histopathologically proven malignant melanoma.
  • Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a.
  • 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.
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  • Life expectancy of at least 12 weeks.
  • Absolute neutrophil count > 1.5 x 10^9/L.
  • Hemoglobin > 9.0 g/dL.
  • Platelets > 100 x 10^9/L.
  • Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl).
  • ALT and AST ≤ 2.5 x the upper limit of normal (ULN) (5.0 x ULN for patients with hepatic involvement with tumor).
  • Serum creatinine < 1.5 x ULN.
  • All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.02) Grade ≤ 1 unless otherwise specified above.
  • 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.

Who cannot join

  • Primary ocular melanoma.
  • Presence of visceral metastases at screening.
  • Evidence of active brain metastases at screening.
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated < 5 years prior to study entry.
  • 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.
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  • History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
  • 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).
  • Severe diabetic retinopathy.
  • Active autoimmune disease.
  • History of organ allograft or stem cell transplantation.
  • Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.
  • Known history of allergy to IL2, or other intravenously administered human proteins/peptides/antibodies.
  • Breast feeding female.
  • Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery).
  • Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
  • Planned administration of growth factors or immunomodulatory agents within 7 days before 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.
  • Patient requires, or is taking, corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
  • Any condition, that in the opinion of the investigator could hamper compliance with the study protocol.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • Medizinischen Hochschule Hannover

    Hanover

  • University Hospital

    Tübingen

Other trials in Germany

Austria1 site

  • Universitätsklinik Graz

    Graz

Other trials in Austria

About this study

Official title: A Phase II Study of Intratumoral Application of L19IL2 in Patients With Stage III/IV Melanoma.

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.

Read the detailed description

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2. L19IL2 binds with high affinity to the EDB domain of Fibronectin, a marker of angiogenesis which is strongly upregulated in malignant melanoma lesions. This binding leads to an increased residence time of the protein at the site of disease. The biologic effect of the IL2 moiety is identical to the one of free IL-2.

The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from histopathologically-proven malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV M1a without visceral metastases. The duration of treatment could be up to 20 weeks. After the end of study visit follow-up is performed every 6 weeks until 12 months from enrollment of each patient.

Tumor assessment will be performed within 2 weeks before start of treatment and at week 12 using immune-related response criteria and RECIST 1.1. To assure that patients do not develop visceral metastases under treatment, an additional tumor assessment will be performed already at week 6 after start of therapy. Assessments at week 24 and 36 will be performed according to RECIST vs. 1.1 criteria only.

Treatment emergent adverse events will be summarized by Common Toxicity Criteria (version 4.02, CTCAE) and worst grade for all treated patients. Laboratory values and change in vital signs will be summarized.

Being tested
Intratumoral injections of L19IL2
Keywords
Interleukin, IL2, monoclonal, antibody, cytokine, metastatic, melanoma, tumor targeting, intratumoral, Malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV without visceral metastases.
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

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

  • Intratumoral injections of L19IL2Drug

    Patients will be treated with intratumoral injections of L19IL2 1-3 x weekly. The maximum cumulative dose per week is 20 MioIU. Treatment duration is up to 20 weeks.

Study groups in NCT01253096
Study groupRoleWhat they receive
L19IL2ExperimentalNot described
Receives: Drug: Intratumoral injections of L19IL2

What is being measured

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

  1. Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 .

    Measured: week 12

Secondary outcomes (7)

  1. Safety of intratumoral administration of L19IL2

    Measured: 1-29 days

  2. Rate of patients with complete response (CR), partial response (PR) and stable disease (SD) of L19IL2 treated Index/Non-Index lesions at week 12.

    Measured: week 12

  3. Duration of objective response and disease control of L19IL2 treated Index/Non-Index lesions

    Measured: week 6-46

  4. Overall survival (OS)

    Measured: 1 year

  5. Rate of patients with complete response (CR), partial response (PR) and stable disease (SD)of all metastases

    Measured: week 12

  6. Objective response rate of all metastases

    Measured: week 24, week 36

  7. Disease control rate of all metastases

    Measured: week 24, week 36

Timeline

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

  1. First posted3 Dec 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01253096
Sponsor's protocol ID
PH-L19IL2-03/09
Status last verified
Nov 2014
First submitted
2 Dec 2010
Last updated
20 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intratumoral injections of L19IL2 in people with Malignant Melanoma, run by Philogen S.p.A. at 3 sites in 2 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 18 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Austria. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 . (time frame: week 12). 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 NCT01253096.

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 20 Nov 2014.

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