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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03784625




Registration number
NCT03784625
Ethics application status
Date submitted
18/12/2018
Date registered
24/12/2018

Titles & IDs
Public title
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012
Scientific title
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study
Secondary ID [1] 0 0
TRANSLA12-143
Secondary ID [2] 0 0
2016-002444-17
Universal Trial Number (UTN)
Trial acronym
MELRIV-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [131I]ICF01012 (therapeutic dose level 1)
Treatment: Drugs - [131I]ICF01012 (therapeutic dose level 2)
Treatment: Drugs - [131I]ICF01012 (therapeutic dose level 3)
Treatment: Drugs - [131I]ICF01012 (therapeutic dose level 4)

Experimental: therapeutic dose activity (level 1) - \[131\]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 2) - \[131\]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 3) - \[131\]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)

Experimental: therapeutic dose activity (level 4) - \[131\]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)


Treatment: Drugs: [131I]ICF01012 (therapeutic dose level 1)
* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 800 MBq/m²

Treatment: Drugs: [131I]ICF01012 (therapeutic dose level 2)
* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 1600 MBq/m²

Treatment: Drugs: [131I]ICF01012 (therapeutic dose level 3)
* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 2700 MBq/m²

Treatment: Drugs: [131I]ICF01012 (therapeutic dose level 4)
* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
* 1 therapeutic injection (D11) at a dose of 4000 MBq/m²
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of the recommended therapeutic dose of [131I] ICF01012
Timepoint [1] 0 0
Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT
Secondary outcome [1] 0 0
Evaluation of the sensitivity and specificity by patients and by lesions of [131I]ICF01012 ICF01012 for the visualization of metastatic melanoma lesions from the examinations made during the selection phase
Timepoint [1] 0 0
selection phase Day 0 - Day 7
Secondary outcome [2] 0 0
Evaluation of the tolerance of [131I] ICF01012 (adverse events assessed by NCI-CTC Version 4.03)
Timepoint [2] 0 0
from the the first dose to the end of study (3 months after diagnostic dose)
Secondary outcome [3] 0 0
Pharmacokinetics of [131I] ICF01012 including the study of biodistribution and excretion (radiation counting of serum, whole blood and urinary samples)
Timepoint [3] 0 0
selection phase Day 0 (diagnostic dose), Day 1, and Day 4, Day 7
Secondary outcome [4] 0 0
Evaluation of the therapeutic response of [131I] ICF01012.
Timepoint [4] 0 0
at 3 months
Secondary outcome [5] 0 0
Evaluation of personal dosimetry for the administration of [131I]ICF01012.
Timepoint [5] 0 0
Selection phase : Day 0, Day 1, Day 4, and Day 7; therapeutic phase : Day 15, Day 18 and Day 25, Day 74

Eligibility
Key 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.
* Creatinine = 1,5 x ULN or creatinine clearance = 60ml/min if creatinine > 1,5 x ULN , Neutrophil > 1,5.109L-1, Platellets > 100 x 109L-1, prothrombine time < 1,3 x control, Hemoglobin > 9 g/dL, facteur V > 80% (or AST, ALT = 3 x LNS (= 5 x ULN if liver metastasis)).
* Normal cardiac fonction (LVEF> 40%).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Clermont-Ferrand

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Jean Perrin
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Florent CACHIN, Pr
Address 0 0
Centre Jean Perrin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Florent CACHIN, Pr
Address 0 0
Country 0 0
Phone 0 0
0473278089
Fax 0 0
Email 0 0
florent.CACHIN@clermont.unicancer.fr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03784625