Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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  • participants needed
  • sponsor
    Centre Jean Perrin
Updated on 31 January 2021
metastatic melanoma
measurable disease
melanoma skin
malignant melanoma of skin


This study is a phase I clinical trial aimed to determine the recommended dose of [131I]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding [131I]ICF01012 ). The [131I]ICF01012 is a targeted radionuclide therapy with a high affinity for melanin.


This study will include a maximum of 36 patients. This study will begin with a preselection part that consists of an injection of [131I]ICF01012 at a diagnostic dose (185 MBq) in order to preselect patients who will receive the therapeutic dose according to the dosimetry results : binding of [131I]ICF01012 on at least a tumoral lesion and an acceptable radiation absorbed dose to major organs.

The second phase will consist of a therapeutic part with a single administration of [131I]ICF01012 at a therapeutic dose. This part is a dose escalation model (4 levels of therapeutic dose were tested)

Condition melanoma, skin cancer, Metastatic Melanoma, Malignant Melanoma
Treatment [131I]ICF01012 (therapeutic dose level 1), [131I]ICF01012 (therapeutic dose level 2), [131I]ICF01012 (therapeutic dose level 3), [131I]ICF01012 (therapeutic dose level 4)
Clinical Study IdentifierNCT03784625
SponsorCentre Jean Perrin
Last Modified on31 January 2021


Yes No Not Sure

Inclusion Criteria

Patient with metastatic melanoma failure to recommended treatments by HAS
Initial histological diagnosis of cutaneous melanoma pigmented or unknown status or choroidal melanoma
Presence of at least one measurable lesion and / or evaluable in 18FDG-PET as PERCIST criteria
Presence of at least one measurable lesion and / or evaluable as CT RECIST 1.1 criteria
WHO performance index 2
Age> 18 years
Life expectancy> 3 months

Exclusion Criteria

Brain metastases symptomatic
Patient with a VI skin phototype
Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of [131I] ICF01012
Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
Other evolutionary known cancer in the past five years
Earlier irradiation of more than 25% of the bone marrow
Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT
External Radiotherapy on target organs or the maximum dose as recommended in force
Uncontrolled diabetes
Known history of allergy to the excipients of the solution of [131I]ICF01012
Any comorbidity or severe disease at the discretion of the investigator
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