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Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012 (MELRIV-1)

Primary Purpose

Melanoma

Status

Recruiting

Phase

Early Phase 1

Locations

France

Study Type

Interventional

Intervention

[131I]ICF01012 (therapeutic dose level 1)

[131I]ICF01012 (therapeutic dose level 2)

[131I]ICF01012 (therapeutic dose level 3)

[131I]ICF01012 (therapeutic dose level 4)

About this trial

This is an interventional treatment trial for Melanoma focused on measuring metastatic melanoma, targeted radionuclide therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Jean PerrinRecruiting
CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

therapeutic dose activity (level 1)

therapeutic dose activity (level 2)

therapeutic dose activity (level 3)

therapeutic dose activity (level 4)

Arm Description

[131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)

[131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)

[131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)

[131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

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

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

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

Full Information

NCT ID

NCT03784625

First Posted

December 18, 2018

Last Updated

February 3, 2023

Sponsor

Centre Jean Perrin

1. Study Identification

Unique Protocol Identification Number

NCT03784625

Brief Title

Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

Acronym

MELRIV-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2019 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Jean Perrin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

metastatic melanoma, targeted radionuclide therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

dose escalation model

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

therapeutic dose activity (level 1)

Arm Type

Experimental

Arm Description

[131]ICF01012 at a therapeutic dose of 800 MBq/m² , single dose at D11 (intravenous administration)

Arm Title

therapeutic dose activity (level 2)

Arm Type

Experimental

Arm Description

[131]ICF01012 at a therapeutic dose of 1600 MBq/m² , single dose at D11 (intravenous administration)

Arm Title

therapeutic dose activity (level 3)

Arm Type

Experimental

Arm Description

[131]ICF01012 at a therapeutic dose of 2700 MBq/m² , single dose at D11 (intravenous administration)

Arm Title

therapeutic dose activity (level 4)

Arm Type

Experimental

Arm Description

[131]ICF01012 at a therapeutic dose of 4000 MBq/m² , single dose at D11 (intravenous administration)

Intervention Type

Drug

Intervention Name(s)

[131I]ICF01012 (therapeutic dose level 1)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

[131I]ICF01012 (therapeutic dose level 2)

Intervention Description

Intervention Type

Drug

Intervention Name(s)

[131I]ICF01012 (therapeutic dose level 3)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

[131I]ICF01012 (therapeutic dose level 4)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Description

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

Time Frame

selection phase Day 0 - Day 7

Title

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

Description

adverse events assessed by NCI-CTC Version 4.03

Time Frame

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

Title

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

Description

radiation counting of serum, whole blood and urinary samples

Time Frame

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

Title

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

Description

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

Time Frame

at 3 months

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Florent CACHIN, Pr

Phone

33473278089

florent.CACHIN@clermont.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florent CACHIN, Pr

Organizational Affiliation

Centre Jean Perrin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Jean Perrin

City

Clermont-Ferrand

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florent Cachin, Pr

First Name & Middle Initial & Last Name & Degree

Florent Cachin, Pr

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandrine Mansard, MD

First Name & Middle Initial & Last Name & Degree

Sandrine Mansard, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35428211

Citation

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.

Results Reference

derived

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Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

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