Informations générales (source: ClinicalTrials.gov)
Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study
Interventional
Phase 3
Institut National de la Santé Et de la Recherche Médicale, France (Voir sur ClinicalTrials)
octobre 2019
octobre 2025
08 septembre 2025
MULTISARC is a randomized multicenter study assessing whether high throughput molecular
analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic
soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large
proportion of patients, with results available within reasonnable delays.
In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided
by high throughput molecular analysis (next generation sequencing exome, RNASeq [NGS]) in
patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line
treatment, participant's tumor profile of experimental Arm NGS (treatment strategy based
on NGS results) will be discussed within a multidisciplinary tumor board which aims at
discussing the genomic profiles and at providing a therapeutic decision for each
participant. Participants for whom a targetable genomic alteration has been identified
will be proposed to enter in one of the subsequent phase II single-arm sub-trial.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:15 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin VERRET | 21/02/2024 10:46:34 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Timone - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Site René Gauducheau - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| IUCT Oncopôle - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pitié Salpétrière - Paris - France | Contact (sur clinicalTrials) | ||||
| ICANS - Institut de Cancérologie Strasbourg - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Randomized phase
Inclusion Criteria:
- Age ≥ 18 years,
- Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the
French NCI
- Unresectable locally advanced and/or metastatic STS
- No previous systemic treatment for advanced disease,
- ECOG ≤ 1
- Adequate hematological and metabolic functions: Hemoglobin > 9 g/dL and albumin > 30
g/L
- Measurable disease according to RECIST 1.1. At least one site of disease must be
uni-dimensionally > 10 mm,
- Availability of suitable frozen archive tumor material obtained from a metastatic
lesion or advanced disease (not previously treated), or at least one lesion that can
be biopsied for research purpose,
- Archived FFPE block of specimen tumor sampling obtained anytime during disease
development for research purpose,
- Eligible to first-line systemic treatment,
- No prior or concurrent malignant disease diagnosed or treated in the last two years
before inclusion. Note that patients with in situ carcinoma of the cervix, or
adequately treated basal cell or squamous cell carcinoma of the skin, or adequately
treated localized prostate cancer, or other localized cancer under maintenance
therapy can be included as long as they don't limit assessment of efficacy of
first-line systemic therapy,
- Participant with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent prior to any study specific
procedure (ICF1)
Exclusion Criteria:
- Radiological evidence of symptomatic or progressive brain metastases,
- Inability to swallow,
- Major problem with intestinal absorption,
- Previous allogeneic bone marrow transplant,
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension,
active bleeding diatheses, or active Hepatitis B, C and HIV or active autoimmune
disease),
- Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol,
- Individuals deprived of liberty or placed under guardianship
- Pregnant or breast feeding women,
- Men or women refusing contraception,
- Previous enrolment in the present study,
- Any contraindication to first-line chemotherapy treatment.
Phase II Sub-trials
Inclusion Criteria:
- Participants already enrolled in MULTISARC and randomized/switched in Arm "NGS",
- ECOG performance status < 1,
- Measurable disease according to RECIST v1.1,
- Molecular alteration identified by molecular profiling,
- Participants who have received a first-line systemic treatment at the inclusion,
- Participants must have advanced disease and must not be a candidate for other
approved therapeutic regimen known to provide significant clinical benefit based on
investigator judgement,
- Participants will have had a minimum of 21 days gap from last chemotherapy or
immunotherapy or any other pharmacological therapy and/or radiotherapy prior to the
first dose of study treatment,
- Women of childbearing potential must have a negative serum pregnancy test within 3
days of enrolment and serum/urine pregnancy test within 24 hours prior to the
administration of the study drug,
- Female with child bearing potential and male participants with partners of child
bearing potential must be willing to use two effectives forms of contraception (1
highly effective method and 1 barrier method), from beginning 3 weeks before the
first dose of investigational product and until 3 months after discontinuing the
study.
- Participant with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent (ICF2) prior to any study
specific procedure.
Main exclusion Criteria:
- Previous treatment with the targeted therapy,
- No "targetable" genomic alteration generated during the screening phase either due
to the lack of alteration or due to ineligible samples for genomic analysis
(MULTISARC),
- Participants with total gastrectomy,
- Major surgery within 30 days prior to entry into the study (excluding placement of
vascular access) or minor surgery within 14 days of entry into the study,
- History of hypersensitivity to involved study drug(s) or of its excipients,
- Radiological evidence of symptomatic or progressive brain metastases,
- Participant with oral anticoagulation therapy,
- Inability to swallow,
- Major problem with intestinal absorption,
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria. Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case
basis after consultation with the Sponsor.
- Previous allogeneic bone marrow transplant,
- Altered hematopoietic or organ function,
- Mean resting corrected QT interval (QTcF)>470msec obtained from 3 consecutive ECGs
- Previous or current maligancies of other histologies within the last 2 years, with
the exception of in situ carcinoma of the cervix, and adequately treated basal cell
or squamous cell carcinoma of the skin and prostate cancer,
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension,
active bleeding diatheses), active uncontrolled systemic bacterial, viral, or fungal
infection > Grade 2 as per NCI CTCAE v5.0
- Chronic or active hepatitis B or hepatitis C. Testing for hepatitis B surface
antigen (HBs Ag) and hepatitis B core antibody (anti HBc) will be performed at
screening,
- Human immunodeficiency virus (HIV) positive,
- Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol,
- Individuals deprived of liberty or placed under guardianship,
- Pregnant or breast feeding women.
Inclusion Criteria:
- Age ≥ 18 years,
- Histology: soft-tissue sarcoma confirmed by the RRePS Network, as recommended by the
French NCI
- Unresectable locally advanced and/or metastatic STS
- No previous systemic treatment for advanced disease,
- ECOG ≤ 1
- Adequate hematological and metabolic functions: Hemoglobin > 9 g/dL and albumin > 30
g/L
- Measurable disease according to RECIST 1.1. At least one site of disease must be
uni-dimensionally > 10 mm,
- Availability of suitable frozen archive tumor material obtained from a metastatic
lesion or advanced disease (not previously treated), or at least one lesion that can
be biopsied for research purpose,
- Archived FFPE block of specimen tumor sampling obtained anytime during disease
development for research purpose,
- Eligible to first-line systemic treatment,
- No prior or concurrent malignant disease diagnosed or treated in the last two years
before inclusion. Note that patients with in situ carcinoma of the cervix, or
adequately treated basal cell or squamous cell carcinoma of the skin, or adequately
treated localized prostate cancer, or other localized cancer under maintenance
therapy can be included as long as they don't limit assessment of efficacy of
first-line systemic therapy,
- Participant with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent prior to any study specific
procedure (ICF1)
Exclusion Criteria:
- Radiological evidence of symptomatic or progressive brain metastases,
- Inability to swallow,
- Major problem with intestinal absorption,
- Previous allogeneic bone marrow transplant,
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension,
active bleeding diatheses, or active Hepatitis B, C and HIV or active autoimmune
disease),
- Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol,
- Individuals deprived of liberty or placed under guardianship
- Pregnant or breast feeding women,
- Men or women refusing contraception,
- Previous enrolment in the present study,
- Any contraindication to first-line chemotherapy treatment.
Phase II Sub-trials
Inclusion Criteria:
- Participants already enrolled in MULTISARC and randomized/switched in Arm "NGS",
- ECOG performance status < 1,
- Measurable disease according to RECIST v1.1,
- Molecular alteration identified by molecular profiling,
- Participants who have received a first-line systemic treatment at the inclusion,
- Participants must have advanced disease and must not be a candidate for other
approved therapeutic regimen known to provide significant clinical benefit based on
investigator judgement,
- Participants will have had a minimum of 21 days gap from last chemotherapy or
immunotherapy or any other pharmacological therapy and/or radiotherapy prior to the
first dose of study treatment,
- Women of childbearing potential must have a negative serum pregnancy test within 3
days of enrolment and serum/urine pregnancy test within 24 hours prior to the
administration of the study drug,
- Female with child bearing potential and male participants with partners of child
bearing potential must be willing to use two effectives forms of contraception (1
highly effective method and 1 barrier method), from beginning 3 weeks before the
first dose of investigational product and until 3 months after discontinuing the
study.
- Participant with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent (ICF2) prior to any study
specific procedure.
Main exclusion Criteria:
- Previous treatment with the targeted therapy,
- No "targetable" genomic alteration generated during the screening phase either due
to the lack of alteration or due to ineligible samples for genomic analysis
(MULTISARC),
- Participants with total gastrectomy,
- Major surgery within 30 days prior to entry into the study (excluding placement of
vascular access) or minor surgery within 14 days of entry into the study,
- History of hypersensitivity to involved study drug(s) or of its excipients,
- Radiological evidence of symptomatic or progressive brain metastases,
- Participant with oral anticoagulation therapy,
- Inability to swallow,
- Major problem with intestinal absorption,
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria. Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case
basis after consultation with the Sponsor.
- Previous allogeneic bone marrow transplant,
- Altered hematopoietic or organ function,
- Mean resting corrected QT interval (QTcF)>470msec obtained from 3 consecutive ECGs
- Previous or current maligancies of other histologies within the last 2 years, with
the exception of in situ carcinoma of the cervix, and adequately treated basal cell
or squamous cell carcinoma of the skin and prostate cancer,
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension,
active bleeding diatheses), active uncontrolled systemic bacterial, viral, or fungal
infection > Grade 2 as per NCI CTCAE v5.0
- Chronic or active hepatitis B or hepatitis C. Testing for hepatitis B surface
antigen (HBs Ag) and hepatitis B core antibody (anti HBc) will be performed at
screening,
- Human immunodeficiency virus (HIV) positive,
- Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol,
- Individuals deprived of liberty or placed under guardianship,
- Pregnant or breast feeding women.