Metastatic MelanomaPhase 2NCT01055522
Clinical Study Phase II of L19IL2 in Combination With Dacarbazine in Patients With Metastatic Melanoma
A Phase 2 study testing Arm 1: L19IL2 + Dacarbazine, Arm 3: Dacarbazine and ARM 2: L19IL2 + Dacarbazine in people with Metastatic Melanoma, run by Philogen S.p.A. at 10 sites in 4 countries.
Trial summary
This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma. The study is divided in two parts: a phase IIa part, designed to establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Arm 1: L19IL2 + Dacarbazine, Arm 3: Dacarbazine and ARM 2: L19IL2 + Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Jun 2008to Feb 2014
- 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
- Histologically or cytologically confirmed unresectable metastatic (stage IV) non-uveal melanoma
- Age > 18 years
- Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria. Cutaneous lesions measuring at least 1 cm will be considered measurable.
- Prior therapy for metastatic melanoma:
- Phase IIa - Dose definition: prior therapy allowed, including prior chemotherapy; previous treatment with DTIC: patients should be treated > 6 months prior to study entry
- Phase IIb -Activity Evaluation: no prior therapy except radiation. However, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
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- Fewer than 3 organs involved or cutaneous and/or subcutaneous metastasis only, for PhaseIIb patients
- ECOG performance status < 2
- 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
- Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/Dl)
- ALT and AST ≤ 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor
- LDH < 2.0 x ULN for Phase IIa patients and normal LDH for the Phase IIb ones.
- Serum creatinine < 1.5 x ULN
- All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
- Negative serum pregnancy test (for women of child-bearing potential only) at screening
Who cannot join
- Primary ocular melanoma
- Evidence of brain metastases, negative CT scan within two months before study commence
- 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 chronic 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
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- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- 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, dacarbazine, or other intravenously administered human proteins/peptides/antibodies.
- Breast feeding female.
- Anti-tumor therapy within 4 weeks of the administration of study treatment.
- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
- Previous DTIC treatment in the last 6 months prior to study entry
- Growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
- 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 conditions that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Italy5 sites
A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - ANCONA (AN) (Italy)
Ancona
European Institute of Oncology
Milan, 20141
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli
Naples
University Hospital Pisa
Pisa, Tuscany, 56126
Azienda Ospedaliera Universitaria Senese
Siena
Germany3 sites
Charité- Universitätsmedizin Berlin
Berlin
Universitätsklinikum Schleswig-Holstein-Campus Kiel
Kiel
University Hospital
Tübingen, 72076
About this study
Official title: Dose Definition and Activity Evaluation Study of the Tumor-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Combination With Dacarbazine in Patients With Metastatic Melanoma
This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.
The study is divided in two parts: a phase IIa part, designed to establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as well as to determine the preliminary tolerability profile; the second phase IIb part evaluates the objective response rate (ORR) including a randomized study with a fixed dose of Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.
Read the detailed description
Dose limiting toxicity will be assessed during the dose-escalation part of Phase IIa from day 1 through day 21 of the first cycle.
Response will be measured using RECIST criteria every 6 weeks (after every 2 cycles of treatment). Patients with stable or responding disease at each assessment may receive additional treatment for a maximum of 6 cycles of induction. Patients with stable or responding disease after induction may receive L19IL2 (without dacarbazine) every 2 weeks as maintenance therapy.
Tumor expression of ED-B FN and tumor uptake of L19IL2 and of Dacarbazine will be assessed via immunohistochemistry and/or other methods deemed appropriate on tumor tissue biopsies. Tumor biopsy will be performed on superficial accessible cutaneous and/or subcutaneous lesions only. Tumor biopsy will be considered optional and will not preclude patient entry on to study should the patient refuse.
Pharmacokinetics of L19IL2, Dacarbazine and AIC will be assessed from serial blood samples using standard methods.
Overall response rate, PFS, survival rate at 6 and 12 months, and overall survival time for all patients and separately for the patients in the Phase IIb part will be assessed using standard methods.
- Conditions
- Metastatic Melanoma
- Being tested
- Arm 1: L19IL2 + Dacarbazine, Arm 3: Dacarbazine, ARM 2: L19IL2 + Dacarbazine
- Keywords
- Interleukin, IL2, monoclonal, antibody, cytokine, Dacarbazine, metastatic, melanoma, tumor targeting, Dose definition, , L19
- 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.
Arm 1: L19IL2 + DacarbazineDrug
RD of L19IL2 determined in phase IIa. Induction Phase A: Intravenous (IV) infusion of L19IL2 on days 1, 3 and 5 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles.
Induction Phase B: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles.
Maintenance: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for a maximum of 1 year after start of treatment.
DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first
Arm 3: DacarbazineDrug
Also called DETICENE®
Dacarbazine Dosage: 1,000 mg/m2 DTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first.
ARM 2: L19IL2 + DacarbazineDrug
RD of L19IL2 determined in phase IIa. Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for for a maximum of 1 year after start of treatment.
DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: L19IL2 + Dacarbazin | Experimental | Not described Receives: Drug: Arm 1: L19IL2 + Dacarbazine |
| ARM 2: L19IL2 + Dacarbazin | Experimental | Not described Receives: Drug: ARM 2: L19IL2 + Dacarbazine |
| ARM 3: Dacarbazin | Active comparator | DTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first Receives: Drug: Arm 3: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine
Measured: 21 days
To evaluate Objective response rate (ORR) by CT or MRI
Measured: 18 weeks
Secondary outcomes (7)
To investigate the Pharmacokinetics of L19IL2, dacarbazine and 5-aminoimidazole -4 carboxamide (AIC).
Measured: 42 days
To investigate the induction of human anti-fusion protein antibodies (HAFA)
Measured: 1 year
To investigate Antitumor activity of L19IL2 with dacarbazine in patients with metastatic melanoma by TC or MRI
Measured: 18 weeks
Evaluation of the immunological activity of study treatment
Measured: 1 year
To estimate progression -free survival (PFS)
Measured: 1 year
To estimate overall survival (OS)
Measured: 1 year
To assess safety and tolerability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJun 2008
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eudax S.r.l.
- Responsible party
- Sponsor
- Investigators
- Chiara Matilde Catania, Dr, Principal investigator, European Istitute of Oncology Milan (Italy)Claus Garbe, Prof. M.D., Principal investigator, University Hospital Tuebingen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055522
- Sponsor's protocol ID
- PH-L19IL2DTIC-03/07
- Other IDs
- 2007-005737-11
- Status last verified
- Oct 2012
- First submitted
- 22 Jan 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eigentler TK, Weide B, de Braud F, Spitaleri G, Romanini A, Pflugfelder A, Gonzalez-Iglesias R, Tasciotti A, Giovannoni L, Schwager K, Lovato V, Kaspar M, Trachsel E, Menssen HD, Neri D, Garbe C. A dose-escalation and signal-generating study of the immunocytokine L19-IL2 in combination with dacarbazine for the therapy of patients with metastatic melanoma. Clin Cancer Res. 2011 Dec 15;17(24):7732-42. doi: 10.1158/1078-0432.CCR-11-1203. Epub 2011 Oct 25.
PubMed 22028492
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Definition and Activity Evaluation Study of the Tumor-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Combination With Dacarbazine in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01055522
- Acronym / sponsor ID
- PH-L19IL2DTIC-03/07
- Conditions
- Metastatic Melanoma
- Keywords
- Interleukin, IL2, monoclonal, antibody, cytokine, Dacarbazine, metastatic, melanoma, tumor targeting, Dose definition, , L19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Eudax S.r.l.
- Study start
- Jun 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.
The study is divided in two parts: a phase IIa part, designed to establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as well as to determine the preliminary tolerability profile; the second phase IIb part evaluates the objective response rate (ORR) including a randomized study with a fixed dose of Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.
Detailed description
Dose limiting toxicity will be assessed during the dose-escalation part of Phase IIa from day 1 through day 21 of the first cycle.
Response will be measured using RECIST criteria every 6 weeks (after every 2 cycles of treatment). Patients with stable or responding disease at each assessment may receive additional treatment for a maximum of 6 cycles of induction. Patients with stable or responding disease after induction may receive L19IL2 (without dacarbazine) every 2 weeks as maintenance therapy.
Tumor expression of ED-B FN and tumor uptake of L19IL2 and of Dacarbazine will be assessed via immunohistochemistry and/or other methods deemed appropriate on tumor tissue biopsies. Tumor biopsy will be performed on superficial accessible cutaneous and/or subcutaneous lesions only. Tumor biopsy will be considered optional and will not preclude patient entry on to study should the patient refuse.
Pharmacokinetics of L19IL2, Dacarbazine and AIC will be assessed from serial blood samples using standard methods.
Overall response rate, PFS, survival rate at 6 and 12 months, and overall survival time for all patients and separately for the patients in the Phase IIb part will be assessed using standard methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1: L19IL2 + Dacarbazin | Experimental | Drug: Arm 1: L19IL2 + Dacarbazine |
| ARM 2: L19IL2 + Dacarbazin | Experimental | Drug: ARM 2: L19IL2 + Dacarbazine |
| ARM 3: Dacarbazin | Active comparator | Drug: Arm 3: DacarbazineDTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed unresectable metastatic (stage IV) non-uveal melanoma
- Age > 18 years
- Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria. Cutaneous lesions measuring at least 1 cm will be considered measurable.
- Prior therapy for metastatic melanoma:
- Fewer than 3 organs involved or cutaneous and/or subcutaneous metastasis only, for PhaseIIb patients
Key exclusion criteria (22 listed)
- Primary ocular melanoma
- Evidence of brain metastases, negative CT scan within two months before study commence
- 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 chronic 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: L19IL2 + DacarbazineRD of L19IL2 determined in phase IIa. Induction Phase A: Intravenous (IV) infusion of L19IL2 on days 1, 3 and 5 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles. Induction Phase B: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for four consecutive 21-day cycles. Maintenance: Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for a maximum of 1 year after start of treatment. DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first | Drug | ARM 1: L19IL2 + Dacarbazin |
| Arm 3: DacarbazineAlso: DETICENE®Dacarbazine Dosage: 1,000 mg/m2 DTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first. | Drug | ARM 3: Dacarbazin |
| ARM 2: L19IL2 + DacarbazineRD of L19IL2 determined in phase IIa. Intravenous (IV) infusion of L19IL2 on days 1, 8 and 15 of each 21-day cycle over 60 minutes via automated device (perfusor), for for a maximum of 1 year after start of treatment. DTIC 1,000mg/m2 every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or one year from initiation of therapy, whichever occurs first | Drug | ARM 2: L19IL2 + Dacarbazin |
Primary outcome
To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine
Time frame: 21 days
To evaluate Objective response rate (ORR) by CT or MRI
Time frame: 18 weeks
7 secondary outcomes
To investigate the Pharmacokinetics of L19IL2, dacarbazine and 5-aminoimidazole -4 carboxamide (AIC).
Time frame: 42 days
To investigate the induction of human anti-fusion protein antibodies (HAFA)
Time frame: 1 year
To investigate Antitumor activity of L19IL2 with dacarbazine in patients with metastatic melanoma by TC or MRI
Time frame: 18 weeks
Evaluation of the immunological activity of study treatment
Time frame: 1 year
To estimate progression -free survival (PFS)
Time frame: 1 year
To estimate overall survival (OS)
Time frame: 1 year
To assess safety and tolerability
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Derived from this study: PubMed 22028492Eigentler TK, Weide B, de Braud F, Spitaleri G, Romanini A, Pflugfelder A, Gonzalez-Iglesias R, Tasciotti A, Giovannoni L, Schwager K, Lovato V, Kaspar M, Trachsel E, Menssen HD, Neri D, Garbe C. A dose-escalation and signal-generating study of the immunocytokine L19-IL2 in combination with dacarbazine for the therapy of patients with metastatic melanoma. Clin Cancer Res. 2011 Dec 15;17(24):7732-42. doi: 10.1158/1078-0432.CCR-11-1203. Epub 2011 Oct 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Matilde Catania, Dr principal investigator
European Istitute of Oncology Milan (Italy)
Claus Garbe, Prof. M.D. principal investigator
University Hospital Tuebingen (Germany)
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm 1: L19IL2 + Dacarbazine, Arm 3: Dacarbazine and ARM 2: L19IL2 + Dacarbazine in people with Metastatic Melanoma, run by Philogen S.p.A. at 10 sites in 4 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 16 inclusion and 22 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: stopped early, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Germany, Austria, Switzerland. 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 was stopped early. Results are not available in the source record.
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?
To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine (time frame: 21 days). The study lists 2 primary outcomes in all. 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 NCT01055522, which also lists 1 linked publication.
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 25 Feb 2014.