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ClinicalTrials.gov ID

NCT05691608

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,800Estimated

Last Update Posted

Aug 13, 2026Actual

Start Date

Sep 9, 2022Actual

Primary Completion Date

Sep 9, 2030Estimated

Completion Date

Sep 9, 2030Estimated

Official Title

MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2

Brief Summary

FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care.

Since 2012, the molecular profiling trials "MOlecular Screening for CAncer Treatment Optimization" (MOSCATO-01) and "MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification" (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX).

The FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge.

The program is articulated in two main parts that are closely interacting:

FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports.

The clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board (CMTB) reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies.

Due to the delay in opening of the MAPPYACTS 2 trial, clinical and molecular data for patients whose tumors were sequenced within FMG2025 or equivalent and not included in MAPPYACTS 2 before CMTB or equivalent, will be collected retrospectively after a specific patient/legal representative information and will contribute to the endpoints of the trial as adequate.

Detailed Description

MAPPYACTS 2 is an ambispective (prospective and retrospective) international multicentric clinical study to provide clinical therapeutic recommendations, to set up the molecular and comprehensive clinical database of patients with relapsed or refractory pediatric malignancies in FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects, to collect the follow-up data on treatment and patients' outcome, in order to determine the outcome of the program in regard to benefit to the single patient, all the patients and to health care. It will also serve as a central link to interventional study platforms and international precision medicine programs, and cover and coordinate ancillary research studies that lead to improve treatment and outcome for children with advanced malignancies.

Clinical recommendations and decisions following tumor sequencing are made based on discussions with biologists, scientists and physicians in the molecular and clinical molecular tumor boards run by the FMG2025 and MAPPYACTS 2 study teams.

Associated ancillary research studies and links to clinical interventional studies are essential components of the program to perform clinical, translational and basic research in order to generate scientific knowledge and develop new treatment strategies that improve outcome of these patients. Research projects are discussed and agreed on in the MAPPYACTS 2 study committee.

• Solid Tumor
• Leukemia

• Solid tumor and CT DNA

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Patient referred for sequencing of the tumor within the FMG2025 or equivalent program and written consent for FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent signed
• Written informed consent for MAPPYACTS 2 (or non-opposition for retrospective clinical data collection) according to local or national regulations
• Patient with confirmed solid tumor or leukemia which is relapsed or refractory to standard treatment and who is potentially eligible for an experimental treatment or an early phase clinical trial at the time of tumor sequencing
• Planned tumor biopsy, surgical resection, bone marrow or blood sample or recently (possibly within the last 3 months) archived frozen tumor material available of the current recurrent or refractory disease
• Patients aged ≤ 25 years at the time of initial diagnosis
• Performance status and life expectancy > 3 months at the time of tumor sequencing that allows enrolment into an experimental trial
• Patients affiliated with a Social Security Regimen or beneficiary of the same as per local regulatory requirements

Exclusion Criteria:

• Any concurrent illness or laboratory abnormality that, in the opinion of the investigator, is likely to interfere with the interpretation of study results
• Pregnant women

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

nadege.corradini@ihope.fr+33 (0)4 69 16 65 95