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    Summary
    EudraCT Number:2019-004388-37
    Sponsor's Protocol Code Number:69HCL19_0457
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-004388-37
    A.3Full title of the trial
    A Three-Cohort Phase II trial to Assess the Efficacy of a Maintenance Treatment with TALAzoparib following First Line Platinum-based Chemotherapy in Pleural and Malignant Peritoneal MESOthelioma Patients: TALAMESO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Three-Cohort Phase II trial to Assess the Efficacy of a Maintenance Treatment with TALAzoparib following First Line Platinum-based Chemotherapy in Pleural and Malignant Peritoneal MESOthelioma Patients: TALAMESO
    A.3.2Name or abbreviated title of the trial where available
    TALAMESO
    A.4.1Sponsor's protocol code number69HCL19_0457
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointIUNG Annie
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number330472406824
    B.5.5Fax number330472115190
    B.5.6E-maildrci_promo@chu-lyon.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TALZENNA
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study involves adults subjects with advanced malignant pleural (cohort A) or peritoneal (cohorts B1 and B2) mesothelioma.
    The cohorts B1 will be patient populations with non-resected or incompletely resected disease and cohort B2, with completely resected disease.
    E.1.1.1Medical condition in easily understood language
    This study involves adults subjects with advanced malignant pleural (cohort A) or peritoneal (cohorts B1 and B2) mesothelioma.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10035605
    E.1.2Term Pleural mesothelioma malignant advanced
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10034669
    E.1.2Term Peritoneal mesothelioma malignant advanced
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy, assessed by the proportion of patients who are free of progression 6 months after starting talazoparib maintenance treatment, that will follow 4 to 6 cycles of platinum-based first line chemotherapy, in patients with advanced malignant pleural (cohort A) or peritoneal mesothelioma (cohorts B1 and B2).
    E.2.2Secondary objectives of the trial
    To assess other efficacy parameters, and survivals
    To assess the safety
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To identifying predictive biomarkers of response to talazoparib
    To characterize genes involved in homologous recombination DNA repair pathway
    To sequence BAP1 gene and assess its protein expression by immunohistochemistry
    To search blood biomarker, predictor of the efficacy
    E.3Principal inclusion criteria
    - Patients older than 18 years old
    - Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    - Histologically - or cytologically- confirmed malignant mesotheliomas: epithelioid, sarcomatoid, biphasic : Developed from pleura (cohort A) or from peritoneum (cohorts B1 and B2); Previously treated with first-line platinum based-chemotherapy (including minimum one cycle of pemetrexed) for 4 to 6 cycles, with no sign of disease progression during chemotherapy.
    - No previous treatment with bevacizumab and PARP inhibitor
    - Minimum 6 weeks and maximum 8 weeks interval between last chemotherapy cycle and talazoparib start : For pleural mesotheliomas (cohort A), primary or interval debulking surgery with or without hyperthermic intrapleural or intrathoracic chemotherapy (HITHOC) will be authorized, in the case of non-complete cytoreductive surgery only; For peritoneal mesotheliomas :
    * In cohort B1, primary or interval debulking surgery ± hyperthermic intraperitoneal chemotherapy (HIPEC) will be authorized in the case of non-complete cytoreductive surgery (CC2 or CC3) only. This cohort will also include patients with non-operated diseases
    * In cohort B2, complete macroscopic (CC0 or CC1) primary or interval debulking surgery ± HIPEC will be required.
    Intraperitoneal treatments with pressurized intraperitoneal aerosol chemotherapy sessions (PIPAC) are not allowed.
    - Measurable or non-measurable (but radiologically evaluable) disease
    - Availability at the study site of a representative Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample in a block or at least 30 unstained slides from biopsy or surgery specimen, aged less than 6 months.
    - Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment
    - Patients with adequate renal function
    - Patients with adequate hepatic function
    - Patients must have a life expectancy ≥ 16 weeks.
    - Confirmation of non-childbearing status (pregnancy test) for women of childbearing potential.
    - A highly effective method of contraception is required for female patients during treatment of talazoparib, and for at least 7 months after completing therapy. Advise male patients with female partners of reproductive potential and pregnant partners to use a condom, during treatment with talazoparib and for at least 4 months after the final dose.
    - Patients who gave its written informed consent to participate to the study.
    - Patients affiliated to a social insurance regime.
    - Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    E.4Principal exclusion criteria
    - Uncontrolled intercurrent illness, including but not limited to, such as congestive heart failure; respiratory distress; liver failure; allergy, or psychiatric illness/social situations that would limit compliance with study requirement according to the investigator, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
    - Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
    - All subjects with brain metastases or meningeal involvement.
    - Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 6 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
    - Persistent toxicities (CTCAE ≥ grade 2) with the exception of alopecia and sensory neuropathy, caused by previous cancer therapy.
    - Treatment with other investigational agents.
    - Bowel occlusive syndrome, inflammatory bowel disease, immune colitis, or other gastro-intestinal disorder that does not allow oral medication such as malabsorption.
    - Known severe hypersensitivity reactions to PARP inhibitors.
    - Known HIV or AIDS related illness.
    - Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
    - Treatment with oral anticoagulant anti-vitamin K such Coumadin®.
    - Prior organ transplantation, including allogeneic stem cell transplantation (excluding autologous bone marrow transplant).
    - Patients under guardianship.
    - Women who are breastfeeding (during treatment with talazoparib and for at least 1 month after the final dose).
    - Participation in other interventional clinical research that may interfere with the experimental drugs efficacy.
    E.5 End points
    E.5.1Primary end point(s)
    Non-progression proportion 6 months after starting talazoparib in TALAMESO trial.
    The non-progression proportion is defined as the proportion of patients free of progression 6 months after talazoparib start. Disease progression will be based on (i) tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, (ii) non-equivocal clinical symptom of disease progression according to the investigator; (iii) death related to disease progression
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after starting talazoparib in TALAMESO trial.
    E.5.2Secondary end point(s)
    Related to progression free-survival based on RECIST 1.1 criteria
    The Progression-Free Survival (PFS) is defined as the time from inclusion to first documented disease progression or death related to disease progression, whichever occurs first or, end of follow-up. If the treatment is stopped for another cause, the event will be censored to the date of the end of the treatment. Disease progression will be based on tumor assessment made by the investigators according to the RECIST 1.1 and/or, non-equivocal clinical symptom of disease progression according to the investigator, and/or death related to disease progression.

    Related to progression free-survival based on mRECIST criteria
    The Progression-Free Survival (PFS) is defined as the time from inclusion to first documented disease progression or death related to disease progression, whichever occurs first or, end of follow-up. If the treatment is stopped for another cause, the event will be censored to the date of the end of the treatment. Disease progression will be based on tumor assessment made by the investigators according to the mRECIST and/or, non-equivocal clinical symptom of disease progression according to the investigator, and/or death related to disease progression.

    Related to overall survival
    The Overall Survival (OS) will be estimated from the date of inclusion to the date of death or to the end of follow-up. The follow-up will end at the date of death, the date of last news or the data cutoff, whichever will come first. Data on patients lost to follow-up or without death at the data cutoff will be censored.
    Related to safety
    Safety is defined as the nature, number and grade of adverse events observed throughout the study and assessed using NCI-CTCAE v.5.0 criteria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The Progression-Free Survival (PFS) is defined as the time from inclusion to first documented disease progression or death related to disease progression, whichever occurs first or, end of follow-up
    The Overall Survival (OS) will be estimated from the date of inclusion to the date of death or to the end of follow-up. The follow-up will end at the date of death, the date of last news or the data cutoff, whichever will come first.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months49
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected treatment following patients' condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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