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    Clinical Trial Results:
    A single arm Phase I-II multicenter trial with avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients.

    Summary
    EudraCT number
    		 2016-003838-24
    Trial protocol
    		 ES  
    Global end of trial date
    15 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2023
    First version publication date
    10 Mar 2023
    Other versions
    Summary report(s)
    		 ICH3 CSR AVEVAC

    Trial information

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    Trial identification
    Sponsor protocol code
    GEMCAD-1602
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03152565
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GEMCAD
    Sponsor organisation address
    C/ Balmes 243 5º 1º, Barcelona, Spain, 08006
    Public contact
    Pau Doñate, MFAR Clinical Research, investigacion@mfar.net
    Scientific contact
    Pau Doñate, MFAR Clinical Research, investigacion@mfar.net
    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
    26 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase I: To determine the recommended phase II dose (RP2D) of avelumab in combination with ADC vaccine in previously treated MSS CRC patients who have progressed at least to 2 chemotherapy lines. Phase II: To increase the percentage (from 20% to 40%) of pre-treated MSS mCRC patients free of progression at 6 months.
    Protection of trial subjects
    The protocol and the patient information sheet as weel as the informed consent contain all measures needed to reduce and mitigate risks for trial subjects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    10
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 28 patients were screened

    Pre-assignment period milestones
    Number of subjects started
    		 28 [1]
    Number of subjects completed
    		 19

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not elegible patient: 8
    Reason: Number of subjects
    		 Apheresis not feasible: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 28 patients were screened in the pre-assignment period. Only 19 comply eligibility and were enrolled in the study and allocated to receive the study treatment
    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Avelumab plus dendritic cell vaccine
    Arm description
    		 Avelumab biweekly intravenous during a maximum of 12 months and biweekly 10x106 ADC vaccine (intradermal) for five doses (days 1, 14, 28, 42 and 56) followed by a maximum of 6 doses every 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab will be administered intravenously at a dose of 10 mg per kilogram of body weight, every 14 days until disease progression or unacceptable toxicity.

    Investigational medicinal product name
    Dendritic cell vaccine (autologous)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10x106 ADC vaccine (intradermal) for five doses (days 1, 14, 28, 42 and 56) followed by a maximum of 6 doses every 6 months

    Number of subjects in period 1
    		Avelumab plus dendritic cell vaccine
    Started
    19
    Completed
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 10 10
    IMMETCOLS
    Number of patients that consume competitively inhibitors of HMG-CoA reductase, an enzyme that limits the rate of cholesterol biosynthesis, and inhibits cholesterol synthesis in the liver.
    Units: Subjects
        Yes
    		 5 5
        No
    		 10 10
        Not evaluable
    		 4 4
    GEP
    Number of patients with expression of Granulin epithelin precursor (GEP), which is reported to function as a growth factor stimulating proliferation and migration, and conferring chemoresistance in many cancer types.
    Units: Subjects
        Yes
    		 5 5
        No
    		 10 10
        Not evaluable
    		 4 4
    LDH
    Measure Description: Number of patients with lactate dehydrogenase (LDH) blood levels in the normal (<234) or higher (>234) range.
    Units: Subjects
        Values < 234
    		 11 11
        Values > 234
    		 8 8
    Local diagnosis
    Number of patients stratified according to the local region of the primary tumor
    Units: Subjects
        Rectum
    		 6 6
        Sigma
    		 13 13
    Local tumor surgery
    Number of patients that had their primary tumor surgically removed
    Units: Subjects
        Yes
    		 13 13
        No
    		 6 6
    Previous treatment lines
    Number of patients classified by the number of previous treatment lines they had received atinclusion. The patients were clustered in 1-2 previous lines or more than 2 previous lines
    Units: Subjects
        Previous lines ≤2
    		 3 3
        Previous lines >2
    		 16 16
    Genotype
    Number of patients with mutations in typical candidate genes for colorectal cancer
    Units: Subjects
        All native
    		 5 5
        KRAS mutant
    		 13 13
        BRAF mutant
    		 1 1
    ECOG
    Number of patients stratified by their East Cooperative Oncology Group (EGOG) performance status (PS). The ECOG PS measures the performance and independence of patients to develop activities of daily living. The score ranges from 0 (fully functional) to 5 (exitus)
    Units: Subjects
        Score 0
    		 13 13
        Score 1
    		 6 6
    Number of affected organs
    Units: Subjects
        1 organ
    		 4 4
        >1 organ
    		 15 15
    Neo/adjuvant chemotherapy
    Number of patients thar received a neo/adjuvant chemotherapy regimen
    Units: Subjects
        Yes
    		 2 2
        No
    		 17 17
    Tumor stage at diagnosis
    Tumor stage measures the level of spread of cancer. Stage 0: This is called cancer in situ. Stage I: The cancer has grown through the mucosa and has invaded the muscular layer of the colon or rectum. Stage II: The cancer has grown through the wall of the colon or rectum but has not spread to nearby tissue or to the nearby lymph nodes. Stage III: The cancer has grown through the inner lining or into the muscle layers of the intestine. It has spread. Stage IV: The cancer has spread to distant part of the body.
    Units: Subjects
        Stage II
    		 1 1
        Stage III
    		 2 2
        Stage IV
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Avelumab plus dendritic cell vaccine
    Reporting group description
    		 Avelumab biweekly intravenous during a maximum of 12 months and biweekly 10x106 ADC vaccine (intradermal) for five doses (days 1, 14, 28, 42 and 56) followed by a maximum of 6 doses every 6 months.

    Primary: Dose of Avelumab in Combination With Autologous Dendritic Cells

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    End point title
    		 Dose of Avelumab in Combination With Autologous Dendritic Cells [1]
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    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: This is a phase I/II trial with a single arm, non randomized, open-label design. There were no control or comparison arms contemplated by the study design. Thus, statistical comparisons are not applicable
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    6 [2]
    Units: miligram / kilogram
        number (not applicable)
    10
    Notes
    [2] - Only those patients in the dose escalation phase
    No statistical analyses for this end point

    Primary: Progression free survival (PFS) rate

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    End point title
    		 Progression free survival (PFS) rate [3]
    End point description
    Percentage of patients without progression of disease at 6 months
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [3] - 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: This is a phase I/II trial with a single arm, non randomized, open-label design. There were no control or comparison arms contemplated by the study design. Thus, statistical comparisons are not applicable
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Patients
        Progression-free patients
    0
        Progression
    19
    No statistical analyses for this end point

    Primary: Progression free survival

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    End point title
    		 Progression free survival [4]
    End point description
    Estimation by kaplan meier of the median PFS. The PFS is defined as time from treatment start until radiological progression disease according to RECIST criteria
    End point type
    Primary
    End point timeframe
    Throughout the study period, average 12 months
    Notes
    [4] - 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: This is a phase I/II trial with a single arm, non randomized, open-label design. There were no control or comparison arms contemplated by the study design. Thus, statistical comparisons are not applicable
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Months
        median (full range (min-max))
    3.1 (2.1 to 5.3)
    No statistical analyses for this end point

    Secondary: KRAS mutational status

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    End point title
    		 KRAS mutational status
    End point description
    KRAS mutation status at baseline and during treatment.
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Patients
        Native
    6
        Mutant
    13
        Not evaluable
    0
    No statistical analyses for this end point

    Secondary: NRAS mutational status

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    End point title
    		 NRAS mutational status
    End point description
    NRAS mutation status at baseline and during treatment.
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Patients
        Native
    17
        Mutated
    0
        Not evaluable
    2
    No statistical analyses for this end point

    Secondary: BRAF mutational status

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    End point title
    		 BRAF mutational status
    End point description
    BRAF mutation status at baseline and during treatment.
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Patients
        Native
    16
        Mutated
    1
        Not evaluable
    2
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Median value of overall survival estimated by kaplan meier. Defined as time from treatment start to death from any cause
    End point type
    Secondary
    End point timeframe
    Throughout the study period, average 12 months
    End point values
    		 Avelumab plus dendritic cell vaccine
    Number of subjects analysed
    19
    Units: Months
        median (full range (min-max))
    12.1 (3.2 to 22.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period, up to 24 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Avelumab plus dendritic cell vaccine
    Reporting group description
    		 Avelumab biweekly intravenous during a maximum of 12 months and biweekly 10x106 ADC vaccine (intradermal) for five doses (days 1, 14, 28, 42 and 56) followed by a maximum of 6 doses every 6 months.

    Serious adverse events
    		 Avelumab plus dendritic cell vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 19 (42.11%)
         number of deaths (all causes)
    18
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Clinical deterioration
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute injury
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle weakness left-sided
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Port-a-cath infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Avelumab plus dendritic cell vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 19 (100.00%)
    General disorders and administration site conditions
    Cough
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    11 / 19 (57.89%)
         occurrences all number
    11
    Fever
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    5
    Infected cyst
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Chills
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pelvic pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Perineal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    chest wall pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Memory impairment
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Mood disorder due to a general medical condition
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Investigations
    Hypocalcaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    ALT increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    AST increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    LDH increased
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    bilirrubin increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    creatinine increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    low hematocrit
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    peripheral neuropathy
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Erythema
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    platelet cound decrease
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    decline of vision
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Flank pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Intestinal obstruction
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Small intestinal obstruction
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    anal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Mucositis oral
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    rectal hemorrage
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    flu like symptoms
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Skin toxicity
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    bollous dermatitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Renal and urinary disorders
    hematuria
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Bone pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    tendinitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    upper respiratory infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    ALK increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Anorexia and bulimia syndrome
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    hyperglycaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2019
    changes in elegibility criteria

    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.
    The study was ended prematurely due to lack of efficacy
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