Solid TumorMAPPYACTS2NCT05691608
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
A study testing Solid tumor and CT DNA in people with Solid Tumor and Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris at 29 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Leukemia
- What is being tested?
- Solid tumor and CT DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 29 sitesFrance
- Study dates
- 9 Sep 2022to 9 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
France29 sites, 29 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, France, 80054
Antoine GOURMEL, Dr, +33 3 22 08 80 00, Gourmel.Antoine@chu-amiens.fr
Antoine GOURMEL, Dr
- Recruiting
CHU Angers
Angers, 49933 Cedex 9
Emilie DE CARLI, Dr, +33 (0)2 41 35 36 37, emdecarli@chu-angers.fr
- Recruiting
CHU Besançon
Besançon, 25030
Sébastien KLEIN, Dr, +33 (0)3 81 66 81 66, s1klein@chu-besancon.fr
- Recruiting
CHU Pellegrin
Bordeaux, 33076
Stéphane DUCASSOU, Dr, +33 (0)5 56 79 56 79, stephane.ducassou@chu-bordeaux.fr
- Recruiting
CHRU Morvan
Brest, 29200
Liana CARAUSU, Dr, +33 (0)2 98 22 33 33, liana.carausu@chu-brest.fr
- Recruiting
CHU de Caen
Caen, 14000
Damien BODET, Dr, +33 (0)2 31 06 31 06, bodet-d@chu-caen.fr
- Recruiting
CHU Estaing
Clermont-Ferrand, 63000
Justyna KANOLD, Dr, +33 (0)4 73 75 07 50, jkanold@chu-clermontferrand.fr
- Recruiting
CHU Dijon François Mitterand
Dijon, 21079
Florent NEUMANN, Dr, +33 (0)3 80 29 30 31, florent.neumann@chu-dijon.fr
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Anne PAGNIER, Dr, +33 (0)4 76 76 75 75, apagnier@chu-grenoble.fr
- Recruiting
Centre Oscar Lambret
Lille, 59020
Sandra RAIMBAULT, Dr, +33 (0)3 20 29 59 59, s-raimbault@o-lambret.fr
- Recruiting
Chu Limoges
Limoges, 87000
Thomas LAUVRAY, MD, +33 (0)5 55 05 55 55, Thomas.LAUVRAY@chu-limoges.fr
- Recruiting
IHOP
Lyon, 69373
Nadège Corradini, MD,PHD, +33 (0)4 69 16 65 95, nadege.corradini@ihope.fr
- Recruiting
CHU La Timone
Marseille, 13005
Nicolas ANDRE, Pr, +33 (0)4 91 38 00 00, Nicolas.ANDRE@ap-hm.fr
- Recruiting
CHU Arnaud de Villeneuve
Montpellier, 34295
Stéphanie HAOUY, Dr, +33 (0)4 67 33 67 33, s-haouy@chu-montpellier.fr
- Recruiting
CHU Nantes
Nantes, 44093
Morgane Clairec, Dr, +33 (0)2 40 08 33 33, morgane.clairec@chu-nantes.fr
- Recruiting
CHU de Nice
Nice, 06202
Pierre ROHRLICH, Dr, +33 (0)4 92 03 77 77, rohrlich.ps@chu-nice.fr
- Recruiting
Hopital Armand Trousseau
Paris, France, 75012
Arnaud PETIT, Dr, +33 1 44 73 74 75, arnaud.petit@aphp.fr
- Recruiting
Gustave Roussy
Paris, Villejuif, 94800
Birgit GEOERGER, MD, birgit.geoerger@gustaveroussy.fr
Gwenaelle BOUDIER, Mrs, +33 (0)142115838, gwenaelle.boudier@gustaveroussy.fr
- Recruiting
Institut Curie
Paris, 75005
Gudrun Schleiermacher, MD,PHD, +33 (0)1 56 24 55 00, gudrun.schleiermacher@curie.fr
- Recruiting
CHU Poitiers
Poitiers, 86022 Cedex
Frédéric MILLOT, Pr, +33 (0)5 49 44 44 44, Frederic.millot@chu-poitiers.fr
- Recruiting
CHU Reims- Hôpital Américain
Reims, 51100
Claire PLUCHART, Dr, +33 (0)3 26 78 78 78, cpluchart@chu-reims.fr
- Recruiting
CHU Rennes Hôpital Sud
Rennes, 35203
Chloé PUISEUX, Dr, +33 (0)2 99 28 43 21, Chloe.PUISEUX@chu-rennes.fr
- Recruiting
CHU de Rouen
Rouen, 76000
Aude MARIE-CARDINE, Dr, +33 2 32 88 89 90, aude.marie-cardine@chu-rouen.fr
- Recruiting
CHU de La Réunion site nord
Saint-Denis, 97400
Yves REGUERRE, Dr, +33 (0)2 62 90 50 50, yves.reguerre@chu-reunion.fr
- Recruiting
CHU Saint Etienne
Saint-Etienne, France, 42270
Sandrine THOUVENIN-DOULET, Dr, +33 4 77 82 80 00, sandrine.thouvenin@chu-st-etienne.fr
- Recruiting
Hôpital de Hautepierre
Strasbourg, 67200
Natacha ENTZ-WERLE, Dr, +33 (0)3 88 11 67 68, Natacha.Entz-Werle@chru-strasbourg.fr
- Recruiting
Hôpital des Enfants - CHU de Toulouse
Toulouse, 31059
Marion GAMBART, Dr, +33 (0)5 61 77 22 33, gambart.m@chu-toulouse.fr
- Recruiting
Hôpital Clocheville
Tours, 37000
Julien LEJEUNE, Dr, +33 (0)2 47 47 47 47, j.lejeune@chu-tours.fr
- Recruiting
CHRU Nancy Hôpital Enfants
Vandœuvre-lès-Nancy, 54500
Ludovic MANSUY, Dr, +33 (0)3 83 85 85 85, lu.mansuy@chru-nancy.fr
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Solid Tumor, Leukemia
- Being tested
- Solid tumor and CT DNA
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid tumor and CT DNABiological
Biopsy and blood sample
| Study group | Role | What they receive |
|---|---|---|
| Patient with solid tumor or leukemia (no treatment) | Experimental | Patient with solid tumor or leukemia (no treatment) Receives: Biological: Solid tumor and CT DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Defined as the time from study entry to death whatever the cause of death, after 3 years, for the whole cohort and according to cancer type.
Measured: 3 years
The number of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
The number of patients receiving matched targeted treatments The number of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The number of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
Measured: 3 years
The types of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
The type of patients receiving matched targeted treatments The type of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The type of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
Measured: 3 years
Secondary outcomes (3)
Objective response rate on treatment attributed by the molecular tumor board in the clinical trial, overall and according to the treatment decision
Objective tumor response measured according to the standard for each tumor entity (i.e. RECIST 1.1, INRC, RANO, etc.).
Assessed for the whole the prospective and retrospective cohorts, for each disease entity as well as for each suggested treatment and until last follow-up.
Measured: 5 years
Progression-free survival (PFS)
Defined as the time interval from start of attributed treatment (targeted or not) to progression or death.
They will be assessed for the whole the prospective and retrospective cohorts, for each disease entity as well as for each suggested treatment and until last follow-up.
Measured: 5 years
5-year overall survival
Defined as the time from study entry to death whatever the cause of death, after 5 years.
They will be assessed for the whole the prospective and retrospective cohorts,, for each disease entity as well as for each suggested treatment and until last follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start9 Sep 2022
- Primary completion9 Sep 2030 (estimated)
- Study completion9 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit GEOERGER, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691608
- Sponsor's protocol ID
- 2021-A02990-41
- Other IDs
- 2021-3321
- Acronym
- MAPPYACTS2
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol Informed Consent Form
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
- ClinicalTrials.gov ID
- NCT05691608
- Acronym / sponsor ID
- MAPPYACTS2 / 2021-A02990-41
- Conditions
- Solid Tumor, Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Sep 2030 (estimated)
- Study completion
- 9 Sep 2030 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with solid tumor or leukemia (no treatment) | Experimental | Biological: Solid tumor and CT DNAPatient with solid tumor or leukemia (no treatment) |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid tumor and CT DNABiopsy and blood sample | Biological | Patient with solid tumor or leukemia (no treatment) |
Primary outcome
Overall survival (OS)
Time frame: 3 years
Defined as the time from study entry to death whatever the cause of death, after 3 years, for the whole cohort and according to cancer type.
The number of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
Time frame: 3 years
The number of patients receiving matched targeted treatments The number of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The number of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
The types of additional technologies and new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program.
Time frame: 3 years
The type of patients receiving matched targeted treatments The type of new treatment strategies that are introduced in the care for advanced pediatric cancers through this research program The type of additional technologies that are introduced in the care for advanced pediatric cancers through this research program
3 secondary outcomes
Objective response rate on treatment attributed by the molecular tumor board in the clinical trial, overall and according to the treatment decision
Time frame: 5 years
Progression-free survival (PFS)
Time frame: 5 years
5-year overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Study protocol Informed Consent Form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgit GEOERGER, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid tumor and CT DNA in people with Solid Tumor and Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris at 29 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgit GEOERGER, MD (+33 (0)1 42 11 46 61, Birgit.GEOERGER@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.