Molecular Profiling of Advanced Soft-tissue Sarcomas (MULTISARC)

  • STATUS
    Recruiting
  • End date
    Oct 28, 2024
  • participants needed
    960
  • sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
Updated on 16 February 2022
cancer
measurable disease
carcinoma
BRAF
KIT
EGFR
cancer chemotherapy

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 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.

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.

Details
Condition Soft Tissue Sarcoma
Treatment Lapatinib, Nilotinib, Palbociclib, Trametinib, TAS-120, Ceritinib, Glasdegib, capmatinib, Trametinib and Dabrafenib, Olaparib and Durvalumab, Next Generation sequencing exome
Clinical Study IdentifierNCT03784014
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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

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
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