NCT05691608: MAPPYACTS2

MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2

Recruiting now NA Last updated 22 August 2025

What this trial tests

NA trial testing Solid tumor and CT DNA in Solid Tumor in 1,800 participants. Currently enrolling.

Timeline

9 September 2022

Primary endpoint
9 September 2030

9 September 2030

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1,800
Start date	9 September 2022
Primary completion	9 September 2030
Estimated completion	9 September 2030
Sites	29 locations across France

Drugs / interventions tested

• Solid tumor and CT DNA — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Leukemia — all drugs for Leukemia →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

Adults 6 to 25, any sex, with Solid Tumor or Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advancing Leukemia Management Through Liquid Biopsy: Insights into Biomarkers and Clinical Utility.
   Hollanda CN, Gualberto ACM, Motoyama AB, Pittella-Silva F. · · 2025 · cited 4× · PMID 40361366 · DOI 10.3390/cancers17091438