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MelanomaEarly Phase 1MELRIV-1NCT03784625

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

A Early Phase 1 study testing [131I]ICF01012 (therapeutic dose level 1), [131I]ICF01012 (therapeutic dose level 2) and [131I]ICF01012 (therapeutic dose level 3) in people with Melanoma, run by Centre Jean Perrin at 2 sites in France.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
[131I]ICF01012 (therapeutic dose level 1), [131I]ICF01012 (therapeutic dose level 2) and [131I]ICF01012 (therapeutic dose level 3)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesFrance
Study dates
18 Oct 2019to 17 Jan 2025
Phase
Early Phase 1
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

  • 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
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  • 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%).

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Jean Perrin

    Clermont-Ferrand

  • CHU Clermont-Ferrand

    Clermont-Ferrand

Other trials in France

About this study

Official title: Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study

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.

Read the detailed description

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)

Conditions
Melanoma
Being tested
[131I]ICF01012 (therapeutic dose level 1), [131I]ICF01012 (therapeutic dose level 2), [131I]ICF01012 (therapeutic dose level 3), [131I]ICF01012 (therapeutic dose level 4)
Keywords
metastatic melanoma, targeted radionuclide therapy
Medical subject headings
Melanoma

What participants receive

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

  • [131I]ICF01012 (therapeutic dose level 1)Drug

    • 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

  • [131I]ICF01012 (therapeutic dose level 2)Drug

    • 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

  • [131I]ICF01012 (therapeutic dose level 3)Drug

    • 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

  • [131I]ICF01012 (therapeutic dose level 4)Drug

    • 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
Study groups in NCT03784625
Study groupRoleWhat they receive
therapeutic dose activity (level 1)Experimental[131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)
Receives: Drug: [131I]ICF01012 (therapeutic dose level 1)
therapeutic dose activity (level 2)Experimental[131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)
Receives: Drug: [131I]ICF01012 (therapeutic dose level 2)
therapeutic dose activity (level 3)Experimental[131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)
Receives: Drug: [131I]ICF01012 (therapeutic dose level 3)
therapeutic dose activity (level 4)Experimental[131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)
Receives: Drug: [131I]ICF01012 (therapeutic dose level 4)

What is being measured

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

  1. Evaluation of the recommended therapeutic dose of [131I] ICF01012

    defined as the highest dose at which the percentage of DLT (dose limiting toxicity) is less than 33%. The DLT is defined as:

    • all non hematologic toxicities NCI-CTC grade 3-4 except for alopecia, nausea, vomiting and fever that can be controlled by appropriate measures.
    • hematologic toxicities as thrombopenia and anemia of grade 4, neutropenia of grade 4 for more than 5 days, thrombopenia of grade 3 with bleeding and all other hematologic toxicities of grade 3 clinically significant of more than 3 weeks

    Measured: Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT

Secondary outcomes (5)

  1. 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

    binding of [131I]ICF01012 compared to standard evaluation of metastatic lesion (standard imaging (CT Scan, TEP ...) or clinical evaluation)

    Measured: selection phase Day 0 - Day 7

  2. Evaluation of the tolerance of [131I] ICF01012 (adverse events assessed by NCI-CTC Version 4.03)

    adverse events assessed by NCI-CTC Version 4.03

    Measured: from the the first dose to the end of study (3 months after diagnostic dose)

  3. Pharmacokinetics of [131I] ICF01012 including the study of biodistribution and excretion (radiation counting of serum, whole blood and urinary samples)

    radiation counting of serum, whole blood and urinary samples

    Measured: selection phase Day 0 (diagnostic dose), Day 1, and Day 4, Day 7

  4. Evaluation of the therapeutic response of [131I] ICF01012.

    Response will be categorized according to the criteria from RECIST 1.1 and PERCIST criteria: complete response, partial response, stable disease and progressive disease

    Measured: at 3 months

  5. Evaluation of personal dosimetry for the administration of [131I]ICF01012.

    assessed by whole-body planar studies and tomographic imaging with single-photon emission computed tomography (SPECT)/CT

    Measured: Selection phase : Day 0, Day 1, Day 4, and Day 7; therapeutic phase : Day 15, Day 18 and Day 25, Day 74

Timeline

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

  1. First posted24 Dec 2018
  2. Study start18 Oct 2019
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
dose escalation model
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03784625
Sponsor's protocol ID
2016-002444-17
Other IDs
TRANSLA12-143, 2016
Acronym
MELRIV-1
Status last verified
Feb 2025
First submitted
18 Dec 2018
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thivat E, Rouanet J, Auzeloux P, Sas N, Jouberton E, Levesque S, Billoux T, Mansard S, Molnar I, Chanchou M, Fois G, Maigne L, Chezal JM, Miot-Noirault E, D'Incan M, Durando X, Cachin F. Phase I study of [131I] ICF01012, a targeted radionuclide therapy, in metastatic melanoma: MELRIV-1 protocol. BMC Cancer. 2022 Apr 15;22(1):417. doi: 10.1186/s12885-022-09495-3.

    PubMed 35428211

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [131I]ICF01012 (therapeutic dose level 1), [131I]ICF01012 (therapeutic dose level 2) and [131I]ICF01012 (therapeutic dose level 3) in people with Melanoma, run by Centre Jean Perrin at 2 sites in France.

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 9 inclusion and 12 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Evaluation of the recommended therapeutic dose of [131I] ICF01012 (time frame: Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT). 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 NCT03784625, 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 13 Feb 2025.

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