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Soft Tissue SarcomaPhase 3MULTISARCNCT03784014

Molecular Profiling of Advanced Soft-tissue Sarcomas

A Phase 3 study testing Nilotinib, Ceritinib and Capmatinib in people with Soft Tissue Sarcoma, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Nilotinib, Ceritinib and Capmatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
17 sitesFrance
Study dates
19 Oct 2019to 20 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 45Show fewer
  • 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)
  • 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.

Who cannot join

  • 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,
Show all 12Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Institut Bergonie

    Bordeaux

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Institut de Cancérologie de Montpellier

    Montpellier

  • Centre Antoine Lacassagne

    Nice

  • Hôpital Cochin

    Paris

  • Hôpital Pitié Salpétrière

    Paris

  • Institut Curie

    Paris

  • CHU Poitiers

    Poitiers, 86000

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain

  • ICANS - Institut de Cancérologie Strasbourg

    Strasbourg, 67033

  • IUCT Oncopôle

    Toulouse

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

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.

Read the detailed description

Screening phase: frozen tumor sample (archived or newly obtained) and blood sample will be used for genetic profiling. Patients can be considered as pre-eligible for the randomized phase when all genetic material have been received by the Platform.

Randomization phase: the randomization will allocate the following arms with a ratio 1:1:

  • experimental Arm NGS : treatment strategy based on NGS results [exome, RNASeq]
  • standard Arm No NGS: treatment strategy not based on NGS (Note that for these participants and under specific conditions, subsequent NGS analyses may be allowed within the scope of the trial)

Single-arm phase II sub-trial: at the end of the first-line treatment and regardless of tumor response as per RECIST v1.1, patients randomized in Arm NGS and for whom a targetable alteration has been identified by the Molecular Tumor Board will be considered as pre-eligible for the targeted sub-study. The mandatory post-chemotherapy wash-out period of 21 days will provide time to achieve all the required tests and examinations.

Being tested
Nilotinib, Ceritinib, Capmatinib, Lapatinib, Trametinib
Keywords
advanced disease, metastatic disease, Next generation sequencing exome
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NilotinibDrug

    Also called TASIGNA

    Target: KIT, PDGFRA, CSF1R Nilotinib will be administered orally, 400 mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • CeritinibDrug

    Also called ZYKADIA

    Target: ALK, ROS. Ceritinib will be administered orally, 450mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • CapmatinibDrug

    Target: MET. Capmatinib will be administered orally, 400mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • LapatinibDrug

    Also called TYVERB

    Target: ERBB2, EGFR. Lapatinib will be administered orally, 1500mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • TrametinibDrug

    Also called MEKINIST

    Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K. Trametinib will be administered orally, 2 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • Trametinib and DabrafenibCombination product

    Also called MEKINIST and TAFINLAR

    Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K, BRAF. Trametinib will be administered orally, 2mg once daily on a continuous basis. Dabrafenib will be administered orally, 150mg twice daily, on a continuous basis.

    A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • Olaparib and DurvalumabCombination product

    Also called LYNPARZA, MEDI4736

    Target: PDL1, PARP. Olaparib will be administered orally, 300mg twice daily on a continuous basis. Dabrafenib will be administered intraveinously, 1500mg on day 1 every 4 weeks. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • PalbociclibDrug

    Also called IBRANCE, PD-0332991

    Target: CDK4, CDK6. Palbociclib will be administered orally, 125mg once daily, 3 weeks on/1 week off.

    A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • GlasdegibDrug

    Also called PF-04449913

    Target: SMO. Glasdegib will be administered orally, 300 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.

  • TAS-120Drug

    Target: FGFR. TAS-120 will be administered orally, 20 mg once daily on a continuous basis. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.

  • Next Generation sequencing exomeOther

    Also called RNA Seq, NGS, High throughput sequencing

    Both frozentumor material (archived or newly obtained) and blood sample collection will be used for genetic profiling

Study groups in NCT03784014
Study groupRoleWhat they receive
Arm No NGSNo interventionPatients will be treated by standard first-line systemic treatment and tumor assessment will be performed every 2 cycles during treatment. Thereafter, disease will be managed as per standard care depending on tumor response observed at the end of the first-line treatment. Note that for these participants and under specific conditions, subsequent NGS analyses may be allowed within the scope of the trial
Arm NGSExperimentalPatients will be treated by standard first-line systemic treatment and tumor assessment will be performed every 2 cycles during treatment. After tumor assessment at the end of first-line systemic treatment and regardless of tumor response as per RECIST v1.1, participants will be discussed within a multidisciplinary tumor board (molecular tumor board-MTB) which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Patients for whom a targetable genomic alteration has been highlighted will be proposed to enter in a subsequent single-arm phase II sub-trials. Otherwise, thereafter, disease will be managed as per standard care depending on tumor response observed at the end of the first-line treatment
Receives: Other: Next Generation sequencing exome
Arm NGS - Targeted therapyExperimentalTargeted therapy from a list of 10 targeted treatment strategies, guided by the genomic analyses: Nilotinib capsule per os 400 mg bd, continuous dosing ; Ceritinib capsule per os 450 mg od, continuous dosing; Capmatinib tablet per os 400 mg bd, continuous dosing; Lapatinib tablet per os 1500 mg od, continuous dosing; Trametinib tablet per os 2 mg od, continuous dosing; association of Trametinib tablet per os 2 mg od and Dabrafenib capsule per os 150 mg bd, continuous dosing; association of Olaparib tablet per os 300 mg bd, continuous dosing and Durvalumab intra-veinous 1500 mg on day 1, Q4W; Palbociclib capsule 125 mg od, 3 weeks on/1 week off; Glasdegib tablet per os 300 mg od, continuous dosing; TAS-120 tablet per os 20 mg od, continuous dosing.
Receives: Drug: Nilotinib; Drug: Ceritinib; Drug: Capmatinib; Drug: Lapatinib; Drug: Trametinib; Combination Product: Trametinib and Dabrafenib; Combination Product: Olaparib and Durvalumab; Drug: Palbociclib; Drug: Glasdegib; Drug: TAS-120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the feasibility of high throughput molecular analysis (next generation sequencing exome [NGS]

    Feasibility will be defined as the proportion of participants for whom results from NGS are (i) interpretable and (ii) for whom a validated report of exome sequencing including a clinical recommendation from the molecular tumor board is available within 7 weeks (i.e. within at most 49 calendar days) after reception of blood and tumor samples by one of the molecular platform.

    Measured: 7 weeks

Secondary outcomes (25)

  1. Comparison of the efficacy of the 2 treatment strategies (NGS vs No NGS) in terms of 1-year progression-free survival (PFS)

    PFS will be defined as the delay from the date of randomization to the date of progression as per RECIST v1.1 (or death, whichever occurs first)

    Measured: 1 year

  2. Comparison of the efficacy of the 2 treatment strategies (NGS vs No NGS) in terms of 2-year progression-free survival (PFS)

    PFS will be defined as the delay from the date of randomization to the date of progression as per RECIST v1.1 (or death, whichever occurs first)

    Measured: 2 years

  3. Comparison of the efficacy of the 2 treatment strategies (NGS vs No NGS) in terms of 1-year overall survival (OS)

    OS will be defined as the delay from the date of randomization to the date of death (whatever the cause)

    Measured: 1 year

  4. Comparison of the efficacy of the 2 treatment strategies (NGS vs No NGS) in terms of 2-year overall survival (OS)

    OS will be defined as the delay from the date of randomization to the date of death (whatever the cause)

    Measured: 2 years

  5. Assessment of the feasibility of high throughput molecular analysis in terms of delay to obtain a clinical recommendation from the molecular tumor board for patients randomized in arm NGS with interpretable NGS

    Delay from the date of signature of the informed consent to the date of the molecular tumor board

    Measured: an average of 7 weeks

  6. Assessment of the proportion of patients with Advanced STS presenting at least one targetable genomic alteration

    A participant will be considered as "presenting at least one targetable genomic alteration", if the MTB considers that at least one genetic alteration identified can be matched with one of the drugs available through the MULTISARC study

    Measured: An average of 7 weeks

  7. Assessment of the efficacy of first-line systemic treatment in terms of 1-year progression-free survival

    PFS will be defined as the delay from the date of onset of first-line treatment to the date of progression as per RECIST v1.1 (or death, whichever occurs first)

    Measured: 1 year

  8. Assessment of the efficacy of first-line systemic treatment in terms of 2-year progression-free survival

    PFS will be defined as the delay from the date of onset of first-line treatment to the date of progression as per RECIST v1.1 (or death, whichever occurs first)

    Measured: 2 years

  9. Assessment of the efficacy of first-line systemic treatment in terms of 1-year overall survival

    OS will be defined as the delay from the date of onset of first-line treatment to the date of death (whatever the cause).

    Measured: 1 year

  10. Assessment of the efficacy of first-line systemic treatment in terms of 2-year overall survival

    OS will be defined as the delay from the date of onset of first-line treatment to the date of death (whatever the cause).

    Measured: 2 years

  11. Assessment of the efficacy of first-line systemic treatment in terms of best overall response under first-line treatment

    Best response is recorded from the date of onset of first-line treatment until the end of first-line treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria

    Measured: Throughout the treatment period, an average of 18 weeks

  12. Assessment of the efficacy of first-line systemic treatment in terms of 6-month objective response

    Objective response is defined as complete or partial response (CR, PR) as per RECIST v1.1 under first-line treatment

    Measured: 6 months

  13. Assessment of the efficacy of first-line systemic treatment in terms of 6-month non progression

    Non progression is defined as complete or partial response (CR, PR) or stable disease (SD) under first-line treatment as defined as per RECIST v1.1

    Measured: 6 months

  14. Assessment of the efficacy of each targeted treatment in terms of 6-month non progression

    Non progression is defined as complete or partial response (CR, PR) or stable disease (SD) under targeted treatment as defined as per RECIST v1.1

    Measured: 6 months

  15. Assessment of the efficacy of each targeted treatment in terms of 1-year progression-free survival

    PFS will be defined as the delay from the date of targeted treatment initiation to the date of progression as per RECIST v1.1 or death, whichever occurs first

    Measured: 1 year

  16. Assessment of the efficacy of each targeted treatment in terms of 1-year overall survival

    OS is defined as the delay from the date of targeted treatment initiation to the date of death (whatever the cause)

    Measured: 1 year

  17. Assessment of the efficacy of each targeted treatment in terms of best overall response under treatment

    Best response (partial or complete, as per RECIST v1.1) recorded from date of targeted treatment initiation taking into account any requirement for confirmation as per RECIST v1.1 criteria

    Measured: Throughout the treatment period, an average of 6 months

  18. Assessment of the efficacy of each targeted treatment in terms of objective response under treatment

    Complete response or partial response under targeted treatment as defined as per RECIST evaluation criteria v1.1

    Measured: Throughout the treatment period, an average of 6 months

  19. Assessment of the efficacy of each targeted treatment in terms of change in tumor size (CTS)

    CTS is defined as the difference (in percentage) in tumor size burden from the date of targeted treatment initiation (baseline) to the tumor assessment

    Measured: Throughout the treatment period, an average of 6 months

  20. Assessment of the safety profile of each targeted treatment using the CTCAE v5

    Safety will be assessed as per CTCAE v5

    Measured: Throughout the treatment period, an average of 6 months

  21. Impact of the results of immunosequencing during first-line treatment

    Correlation of TCR-sequencing data with objective response (OR), OR), progression-free survival (PFS) and overall survival (OS).

    Evaluation of the association between immune profiles derived from ancillary analyses (VISIUM HD, multiplex IF, SomaScan proteomics) and treatment response, within an integrated immunosequencing framework.

    Measured: At cycle 2 day 1 of targeted treatment

  22. To estimate the cost-effectiveness of the strategy usdin NGS as compared to the strategy without NGS

    The outcome will be the incremental cost-utility ratio or the incremental cost per incremental Quality Adjusted Life Year (QALY)

    Measured: Trhoughout the study period, an average of 2 years

  23. To assess the feasibility of NGS in participants who have switched treatment arm for NGS arm in terms of proportion of participants with interpretable NGS results

    Proportion of participants with interpretable NGS results

    Measured: an average of 7 weeks

  24. To assess the feasibility of NGS in participants who have switched treatment arm for NGS arm in terms of delays

    Delay from the date of treatment failure (progression, investigator decision, end of last treatment line) to the date of the molecular tumor board

    Measured: an average of 7 weeks

  25. To assess the feasibility of NGS in participants who have switched treatment arm for NGS arm in terms of proportion of participants with interpretable NGS results

    Proportion of participants presenting at least one targetable genomic alteration

    Measured: an average of 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2018
  2. Study start19 Oct 2019
  3. Primary completion1 Dec 2023
  4. Study completion20 Jan 2026

Resources

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 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced soft tissue sarcoma participants. In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis, in participants with advanced soft-tissue sarcomas. Randomization 1:1 with 1 participant randomized in experimental Arm NGS (treatment strategy based on NGS) and 1 participant randomized in standard Arm No NGS (treatment strategy not based on NGS). At the end of first-line treatment, participant's tumor profile of experimental Arm NGS 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.
Masking
None (open label)
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03784014
Sponsor's protocol ID
C16-40
Other IDs
2024-514873-22-00, 2017-002851-27, 2017
Acronym
MULTISARC
Status last verified
Apr 2026
First submitted
19 Dec 2018
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from the MULTISARC study will be integrated into the Data Collector and Analyzer (CAD) provided for the Plan for Personalized Genomic Medicine 2025, where they will be stored for use in diagnostic and prognostic decision support, the development of therapeutic strategies, and health-related research, studies and evaluations. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of scientific and ethic commitee of the CAD.

Publications

  • Italiano A. Is There Value in Molecular Profiling of Soft-Tissue Sarcoma? Curr Treat Options Oncol. 2018 Dec 7;19(12):78. doi: 10.1007/s11864-018-0589-y.

    PubMed 30523434

  • FGM 2025 Workflow Study Group (Alliance nationale des Sciences de la Vie et de la Sante); Auzanneau C, Bacq D, Bellera C, Blons H, Boland A, Boucheix M, Bourdon A, Chollet E, Chomienne C, Deleuze JF, Delmas C, Dinart D, Esperou H, Geillon F, Geneste D, Italiano A, Jean D, Khalifa E, Laizet Y, Laurent-Puig P, Lethimonnier F, Levy-Marchal C, Lucchesi C, Malle C, Mancini P, Mathoulin-Pelissier S, Meyer V, Marie-Ange P, Perkins G, Sellan-Albert S, Soubeyran I, Wallet C. Feasibility of high-throughput sequencing in clinical routine cancer care: lessons from the cancer pilot project of the France Genomic Medicine 2025 plan. ESMO Open. 2020 Jul;5(4):e000744. doi: 10.1136/esmoopen-2020-000744.

    PubMed 32713836

  • Italiano A, Dinart D, Soubeyran I, Bellera C, Esperou H, Delmas C, Mercier N, Albert S, Poignie L, Boland A, Bourdon A, Geneste D, Cavaille Q, Laizet Y, Khalifa E, Auzanneau C, Squiban B, Truffaux N, Olaso R, Gerber Z, Wallet C, Benard A, Blay JY, Laurent-Puig P, Deleuze JF, Lucchesi C, Mathoulin-Pelissier S; MULTISARC study group. Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial. BMC Cancer. 2021 Nov 5;21(1):1180. doi: 10.1186/s12885-021-08878-2.

    PubMed 34740331

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nilotinib, Ceritinib and Capmatinib in people with Soft Tissue Sarcoma, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 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 45 inclusion and 12 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the feasibility of high throughput molecular analysis (next generation sequencing exome [NGS] (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784014, which also lists 3 linked publications.

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 29 Apr 2026.

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