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    Clinical Trial Results:
    A MolEcularly Guided Anti-Cancer Drug Off-Label Trial – a multicenter, basket and umbrella explorative trial on the efficacy and safety of molecular profile selected commercially available targeted anti-cancer drugs in patients with advanced cancers progressive on standard therapy

    Summary
    EudraCT number
    		 2018-004623-36
    Trial protocol
    		 SE  
    Global end of trial date
    30 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jan 2026
    First version publication date
    28 Jan 2026
    Other versions
    Summary report(s)
    		 Publication Megalit

    Trial information

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    Trial identification
    Sponsor protocol code
    MEGALiT1901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala university hospital
    Sponsor organisation address
    Sjukhusvägen, Uppsala, Sweden, 75185
    Public contact
    KFUE, Uppsala University Hospital, +46 0186115275, kfue@akademiska.se
    Scientific contact
    Peter Nygren, Uppsala University Hospital, +46 0186110000, peter.nygren@igp.uu.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the anti-tumor activity of the genomics guided therapy. • To describe and assess the clinical feasibility, including safety, of therapy selection based on genomic profiling of fresh tumor tissue.
    Protection of trial subjects
    The study was conducted in accorrdance with ICH GCP and the Helsinki declaration.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    16 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 153
    Worldwide total number of subjects
    153
    EEA total number of subjects
    153
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    153
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 153 patients with cancer, where all treatment options had been exhausted, were included (i.e. treatment targets were evaluated). Actionable targets were discovered for 49 patients. 44 patients were allocated a treatment option, and of these 38 patiens were treated in the trial.

    Pre-assignment
    Screening details
    		 Adult (age >18 years) Retrievable or available tissue allowing for molecular analysis; tumor tissue procured specifically for the trial or archived tumor tissue and/or ctDNA according to triage Figure 2. ECOG performance status 0-2 with expected stable disease for the up to 6 weeks run-in period prior to treatment decision

    Period 1
    Period 1 title
    Treatment cohort (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment cohort
    Arm description
    		 Subjects treated based on genetic markers in the trial
    Arm type
    		 Experimental

    Investigational medicinal product name
    niraparib
    Investigational medicinal product code
    L01XK02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to SnPC

    Investigational medicinal product name
    atezolizumab
    Investigational medicinal product code
    L01FF05
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to SmPC

    Investigational medicinal product name
    cobimetinib
    Investigational medicinal product code
    L01EE02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to SmPC

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    L01EG02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to SmPC

    Number of subjects in period 1 [1]
    		Treatment cohort
    Started
    38
    Completed
    0
    Not completed
    38
         Physician decision
    38
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 153 patients were tested in the trial, and 38 were treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment cohort
    Reporting group description
    		 Patients with actionable target for treatment based on genetic tumor analysis

    Reporting group values
    		 Treatment cohort Total
    Number of subjects
    		 38 38
    Age categorical
    Age 18 or more
    Units: Subjects
        18 or more
    		 38 38
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients where oncologic treatment could be administered based on actionable genetic target

    Subject analysis sets values
    		 Treated patients
    Number of subjects
    38
    Age categorical
    Age 18 or more
    Units: Subjects
        18 or more
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    13

    End points

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    End points reporting groups
    Reporting group title
    Treatment cohort
    Reporting group description
    		 Subjects treated based on genetic markers in the trial

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients where oncologic treatment could be administered based on actionable genetic target

    Primary: Overall response rate

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    End point title
    		 Overall response rate [1]
    End point description
    Objective Response Rate (ORR) and tumor control rate [Time Frame: From first dose up to 24 months]. The proportion of patients that have a best overall response of complete response (CR), partial response (PR) or stable disease ≥16 weeks, as assessed by RECIST 1.1 criteria (and/or, as applicable, tumor type specific criteria as defined by diagnose-specific APPENDIX VIII and efficacy evaluation criteria in APPENDIX II).
    End point type
    Primary
    End point timeframe
    up to 24 months after first treatment.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is done by descriptive analysis.
    End point values
    		 Treated patients
    Number of subjects analysed
    Units: Recist 1.1
        number (not applicable)
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Treated patients
    Reporting group description
    		 Patients who were treated based on actionable genetic target in the trial

    Serious adverse events
    		 Treated patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 38 (39.47%)
         number of deaths (all causes)
    33
         number of deaths resulting from adverse events
    1
    Investigations
    Hospitalisation
    Additional description: Unplanned hospitalization due to syncope
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Vomiting
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Embolism
    Additional description: Thromboembolic event
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Myositis
    Additional description: Immune-related myositis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Perforation
    Additional description: Perforation of intestine due to carcinomatosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatitis
    Additional description: Autoimmune Hepatitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver disorder
    Additional description: High liver values
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: Prolongued hospitalization and death
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pleural effusion
    Additional description: Pleaura fluid
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Headache
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
    Additional description: Fever
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treated patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 38 (86.84%)
    Investigations
    Laboratory test abnormal
    Additional description: increased liver enzes, hypoalbumiemi, Low LPK, Creatinin koinase increase, Hopo-natremia,
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    8
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Embolism
    Additional description: Thromboembolic event
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nervous system disorders
    Cognitive disorder
    Additional description: Cognitive disturbance
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hydrocephalus
    Additional description: Worsening hydrocephalus
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Balance disorder
    Additional description: balance worsening
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    10
    General disorders and administration site conditions
    Pain
    Additional description: Abdominal pain, joint pain, myalgia, increased cancer pain, arthralgia, intermittent headache, pain after biopsy
         subjects affected / exposed
    8 / 38 (21.05%)
         occurrences all number
    11
    Ascites
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Dehydration
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    8 / 38 (21.05%)
         occurrences all number
    8
    Syncope
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Immune system disorders
    Immune system disorder
    Additional description: Bullous Phemphigiod, Immune related reaction
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Gastrointestinal disorders
    Gastrointestinal disorder
    Additional description: Abd pain, nausea, diarrhea, vomiting, stomatitis, anorexia
         subjects affected / exposed
    14 / 38 (36.84%)
         occurrences all number
    23
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
    Additional description: Pleural effusion left lung, chough, dyspnoea
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Skin disorder
    Additional description: puritus, rash, ateroma, photosemnsitivity, scalp pain, genital blisters, hematoma around nails
         subjects affected / exposed
    8 / 38 (21.05%)
         occurrences all number
    12
    Endocrine disorders
    Diabetes mellitus
    Additional description: Diabetes, diabetes worsening
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Infections and infestations
    Infection
    Additional description: Fever, Covid-19, Flu-like sumptoms, common cold, infection other
         subjects affected / exposed
    9 / 38 (23.68%)
         occurrences all number
    11
    Metabolism and nutrition disorders
    Weight decreased
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Sep 2020
    Amendment 01 IB Atezolizumab v15 & v15 add 2, Cobimetinib v12 5.1-2020-67147
    16 Jan 2021
    Amendment 02 delayed opening of 4th treatment cohort 5.1-2020-86074
    12 Apr 2022
    Amendment 03 IB Niraparib v 13, IB Atezolizumab Version 18, IB Cobimetinib Version 14 5.1-2022-27257
    19 Aug 2022
    Amendment 04 protokoll v 2.0 5.1-2022-55217
    04 Jan 2023
    Amendment 05 IB Niraparib V. 14 5.1-2022-91841
    03 May 2023
    Amendment 06 protokoll v 3.0 5.1-2023-28319

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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