A Phase II open label randomized parallel group non comparative trial to assess efficacy and safety of the association of IPH1101 and IL-2 alone and in combination with dacarbazine, in patients with metastatic melanoma

• Register: EUCTR
• Last refreshed on: 21 October 2013
• Main ID: EUCTR2007-007265-20-BE
• Date of registration: 06/05/2008
• Prospective Registration: No
• Primary sponsor: Innate Pharma
• Public title: A Phase II open label randomized parallel group non comparative trial to assess efficacy and safety of the association of IPH1101 and IL-2 alone and in combination with dacarbazine, in patients with metastatic melanoma
• Scientific title: A Phase II open label randomized parallel group non comparative trial to assess efficacy and safety of the association of IPH1101 and IL-2 alone and in combination with dacarbazine, in patients with metastatic melanoma
• Date of first enrolment: 18/04/2008
• Target sample size: 50
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007265-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, France

Key inclusion & exclusion criteria

Inclusion criteria:
1) Male or female aged over 18 years,
2) Histologically confirmed diagnosis of melanoma,
3) Stage IV disease or unresectable stage III c (AJCC ),
4) Measurable disease according to modified RECIST criteria defined as at least 1 malignant lesion that could be accurately and serially measured in at least 1 dimension and for which the greatest diameter is > or = 10 mm as measured by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI), or > or = 20 mm with conventional techniques. A caliper can be used for the measurement of superficial cutaneous metastases which are > or = 10 mm;
5) Patient who has never been treated by chemotherapy previously,
6) ECOG performance status < 1,
7) Serum lactate dehydrogenase (LDH) < 1,1 x ULN,
8) At least 4 weeks since major prior surgery,
9) QTc interval duration < 430 ms for men, < 450 ms for women,
10) Adequate bone marrow, hepatic and renal function as follows:
- Lymphocytes > ou = 0.9 109/L
- Platelets > ou 100 x 109/L,
- Total bilirubin < ou = 2 x upper limit normal (ULN)
- Transaminases (AST [SGOT]; ALT SGPT]) < ou = 3 x ULN
- Serum creatinine < ou = 2.0 mg/dL or calculated creatinine clearance > 60mL/min;
11) Male or female patient who accepts and is able to use recognised highly effective contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) throughout the study and during 3 months after the end of treatment;
12) Signed informed consent prior to any protocol-specific 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Primary ocular or mucosal melanoma;
2) Presence of any brain metastasis;
3) Concurrent treatment with any other anti-cancer therapy or any forbidden concomitant treatments;
4) Participation in another clinical trial with any investigative drug within 30 days prior to study randomization;
5) Prior history of high dose chemotherapy followed by bone marrow or peripheral stem cell support or presence of transplanted solid organ (with the exception of corneal transplant > 3 months prior to study randomization);
6) Any known hypersensitivity to one of the study treatments;
7) Any active auto-immune disease including the insulin-dependent diabetes or an immunodeficiency. The vitiligo is not an exclusion criterion;
8) Current active infection on the day of inclusion and judged serious by the investigator including viral infection HIV, HCV, HBV (HBsAg);
9) Serious concurrent, uncontrolled medical disorder such as diabetes;
10) Cardiovascular disease:
-Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA stage I or II CHF may be included provided they do not have arrhythmia requiring treatment or fulfil any other exclusion criteria;
-Myocardial infarction within the previous 6 months, or
-Symptomatic cardiac arrhythmia requiring treatment;
11) History of another malignancy within the past 5 years, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
12) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before request for randomization in the trial;
13) Pregnant or lactating women.



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

Health Condition(s) or Problem(s) studied

metastatic melanoma
MedDRA version: 9.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma

Intervention(s)

Product Name: Phosphostim 200
Product Code: IPH1101
Pharmaceutical Form: Powder for solution for infusion

Trade Name: PROLEUKIN 18 MUI
Product Name: PROLEUKIN 18 MUI
Pharmaceutical Form: Powder for solution for injection

Trade Name: Dacarbazine Mayne 600 mg, poudre pour solution injectable
Product Name: Dacarbazine Mayne 600 mg
Product Code: DTIC
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: dacarbazine
CAS Number: 4342-03-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Main Objective: The primary objective is to assess the efficacy of IPH1101/IL-2 in monotherapy and in combination with Dacarbazine in advanced melanoma patients.

Secondary Objective: The secondary objectives are:
- To determine the safety of IPH1101/ IL-2 association alone and in combination with dacarbazine
- To assess the biological activity of the treatment
- To investigate the relationship between biological activity and efficacy of the treatment.

Primary end point(s): The primary endpoint will be the evaluation of the objective response rate according to modified RECIST criteria. The objective response rate will be presented along with a 90% confidence interval in each arm.

Secondary ID(s)

IPH1101-205

2007-007265-20-FR