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    Clinical Trial Results:
    First-in-human, dose titration and expansion trial to evaluate safety, immunogenicity and preliminary efficacy of W_pro1 (BNT112) monotherapy and in combination with cemiplimab in patients with prostate cancer

    Summary
    EudraCT number
    		 2018-004321-86
    Trial protocol
    		 GB   HU   DE  
    Global end of trial date
    23 Jan 2024

    Results information
    Results version number
    		 v1
    This version publication date
    07 Feb 2025
    First version publication date
    07 Feb 2025
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    RN5609C00
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04382898
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech SE, BioNTech SE, 0049 613190840, patients@biontech.de
    Scientific contact
    BioNTech SE, BioNTech SE, 0049 613190840, patients@biontech.de
    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
    10 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives for the study were: For Part 1 and Part 2: To assess safety and tolerability profile of W_pro1 (BNT112-01) monotherapy or in combination with cemiplimab. For Part 2 Arms 1a and 1b: To evaluate preliminary antitumor activity of W_pro1 (BNT112-01) monotherapy and in combination with cemiplimab in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) based on objective response rate (ORR).
    Protection of trial subjects
    The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2019
    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
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 18
    Worldwide total number of subjects
    75
    EEA total number of subjects
    40
    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)
    26
    From 65 to 84 years
    48
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial consisted of 2 parts: Part 1 (dose titration) and Part 2 (dose expansion; consisted of four arms).

    Pre-assignment
    Screening details
    		 Part 1 and Part 2 (Arms 1A and 1B) enrolled subjects with metastatic castration-resistant prostate cancer (mCRPC). Part 2: Arms 2 and 3 enrolled subjects with newly diagnosed high-risk localized prostate cancer (LPC). A total of 75 subjects were enrolled in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1 (mCRPC): BNT112
    Arm description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT112
    Investigational medicinal product code
    BNT112
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    BNT112 administered as five slow IV bolus injections.

    Arm title
    		 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab
    Arm description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cemiplimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cemiplimab administered as IV infusion.

    Investigational medicinal product name
    BNT112
    Investigational medicinal product code
    BNT112
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    BNT112 administered as five slow IV bolus injections.

    Arm title
    		 Part 2 (mCRPC): Arm 1b: BNT112
    Arm description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT112
    Investigational medicinal product code
    BNT112
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    BNT112 administered as five slow IV injections.

    Arm title
    		 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab
    Arm description
    		 Subjects with high-risk, localised prostate cancer (LPC) received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT112
    Investigational medicinal product code
    BNT112
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    BNT112 administered as five slow IV injections.

    Investigational medicinal product name
    Cemiplimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cemiplimab administered as IV infusion.

    Arm title
    		 Part 2 (LPC): Arm 3: BNT112
    Arm description
    		 Subjects with high-risk LPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT112
    Investigational medicinal product code
    BNT112
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    BNT112 administered as five slow IV injections.

    Number of subjects in period 1
    		Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Started
    9
    28
    27
    5
    6
    Completed
    2
    10
    9
    4
    5
    Not completed
    7
    18
    18
    1
    1
         Consent withdrawn by subject
    1
    -
    1
    -
    -
         Study Terminated By Sponsor
    -
    1
    1
    -
    1
         Death
    6
    17
    13
    1
    -
         Progressive Disease
    -
    -
    1
    -
    -
         Unspecified
    -
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1 (mCRPC): BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1b: BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (LPC): Arm 2: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with high-risk, localised prostate cancer (LPC) received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Reporting group title
    Part 2 (LPC): Arm 3: BNT112
    Reporting group description
    		 Subjects with high-risk LPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Reporting group values
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112 Total
    Number of subjects
    		 9 28 27 5 6 75
    Age categorical
    Units: Subjects
        < 50 years
    		 0 0 0 0 0 0
        >= 50 - < 65 years
    		 1 7 11 3 4 26
        >= 65 - < 85 years
    		 8 20 16 2 2 48
        >= 85 years
    		 0 1 0 0 0 1
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0 0 0
        Male
    		 9 28 27 5 6 75
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 1 0 0 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 1 1 2 1 5
        White
    		 8 27 26 3 5 69
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 4 0 0 0 4
        Not Hispanic or Latino
    		 9 23 27 4 6 69
        Unknown or Not Reported
    		 0 1 0 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Part 1 (mCRPC): BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1b: BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (LPC): Arm 2: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with high-risk, localised prostate cancer (LPC) received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Reporting group title
    Part 2 (LPC): Arm 3: BNT112
    Reporting group description
    		 Subjects with high-risk LPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Primary: Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs)

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    End point title
    		 Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs) [1] [2]
    End point description
    DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to [>=] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome [CRS], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade >=3 non-hematological TEAE at least possibly related which occurs during the first BNT112 cancer vaccine treatment cycle). Analysis was performed on the DLT evaluation set that included all subjects who received IMP and completed the DLT evaluation period and met the minimum exposure criterion or experienced a DLT during Cycle 1.
    End point type
    Primary
    End point timeframe
    Cycle 1 (21 days)
    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: As the primary endpoint was descriptive in nature, no statistical testing was planned.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for Part 2 arms due to early termination of the study.
    End point values
    		 Part 1 (mCRPC): BNT112
    Number of subjects analysed
    9
    Units: subjects
    2
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure [3]
    End point description
    TEAE: any adverse event (AE) with an onset date on or after the first administration of investigational medicinal product (IMP) or worsened after first administration of IMP. AEs with an onset date more than 30 days after last dose of BNT112 or 90 days after last dose of cemiplimab (Part 2: Arm 1a and Arm 2) were only considered as TEAEs if assessed as related to IMP by investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; Grade 5: Death related to AE. Safety set.
    End point type
    Primary
    End point timeframe
    From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arms 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month)
    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: As the primary endpoint was descriptive in nature, no statistical testing was planned.
    End point values
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Number of subjects analysed
    9
    28
    27
    5
    6
    Units: subjects
        TEAEs
    8
    28
    26
    5
    6
        Serious TEAE
    5
    5
    9
    2
    2
        Grade >= 3 TEAEs
    7
    15
    15
    1
    4
        Grade 5 TEAEs
    2
    0
    1
    0
    0
        TEAEs related to trial procedure
    1
    1
    0
    1
    2
    No statistical analyses for this end point

    Primary: Part 2 Arm 1b: Objective Response Rate (ORR)

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    End point title
    		 Part 2 Arm 1b: Objective Response Rate (ORR) [4] [5]
    End point description
    ORR was defined as the percentage of subjects with a CR or PR as per PCWG3 criteria as determined by the investigator. Subjects not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to <10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. Analysis was performed on mITT population.
    End point type
    Primary
    End point timeframe
    From start of treatment up to 104 weeks
    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: Statistical Analysis data is added in chart form for ORR: Part 2: Arm 1b.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for Part 2: Arms 2 and 3.
    End point values
    		 Part 2 (mCRPC): Arm 1b: BNT112
    Number of subjects analysed
    25
    Units: percentage of subjects
        number (confidence interval 95%)
    12.0 (2.5 to 31.2)
    Attachments
    		 Statistical Analysis 1 for Part 2 Arms 1b
    No statistical analyses for this end point

    Primary: Part 2 Arms 1a: Objective Response Rate (ORR)

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    End point title
    		 Part 2 Arms 1a: Objective Response Rate (ORR) [6] [7]
    End point description
    ORR was defined as the percentage of subjects with a complete response (CR) or partial response (PR) as per Prostate Cancer Working Group 3 (PCWG3) criteria as determined by the investigator. Subjects not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to <10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. Analysis was performed on modified Intent to Treat population (mITT) population that included all subjects who were randomised to the IMP and had a baseline and at least one post-baseline (i.e., one on-treatment or post-treatment) tumor assessment (clinical or imaging assessment).
    End point type
    Primary
    End point timeframe
    From start of treatment up to 46 weeks
    Notes
    [6] - 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 data is added in chart form for ORR: Part 2: Arm 1a.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for Part 2: Arms 2 and 3.
    End point values
    		 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab
    Number of subjects analysed
    27
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 12.8)
    Attachments
    		 Statistical Analysis 1 for Part 2 Arms 1a
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels

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    End point title
    		 Number of Subjects Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels
    End point description
    Subjects blood samples were tested for levels of PSA to track the progression of prostate cancer. PSA decline categories of No decline, 0 to 25%, >25% to 50%, and >50% compared to baseline during treatment according to PCWG3 (as reported by the investigator) are reported in this endpoint. Analysis was performed on mITT population. Here, “number of subjects analysed” = subjects with available data for this endpoint and "n" signifies subjects with available data for each specified category at respective visit and “99999” in the data field signifies that no subjects were available for analysis at the specified visit.
    End point type
    Secondary
    End point timeframe
    Day 8 (Cycles 1 and 2 only), Day 1 Cycle 2 and Day 15 (Cycles 1, 2 and 8 only) (each cycle of 21-days), and End of treatment ([EOT]; up to 24 months)
    End point values
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Number of subjects analysed
    8
    24
    23
    5
    6
    Units: subjects
        Cycle 1 Day 8: No decline (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    1
        Cycle 1 Day 8: 0 to 25% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 8:Greater than(>) 25%-50%(n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 8: >50% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 15: No decline (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 15: 0 to 25% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 15:> 25% to 50% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    1
        Cycle 1 Day 15:> 50% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 2 Day 1: No decline (n=8,24,23,5,6)
    6
    21
    19
    1
    0
        Cycle 2 Day 1: 0 to 25% (n=8,24,23,5,6)
    2
    3
    2
    1
    1
        Cycle 2 Day 1: >25% to 50% (n=8,24,23,5,6)
    0
    0
    1
    0
    1
        Cycle 2 Day 1: >50% (n=8,24,23,5,6)
    0
    0
    1
    3
    4
        Cycle 2 Day 8: No decline (n=1,0,0,0,1)
    1
    99999
    99999
    99999
    0
        Cycle 2 Day 8: 0 to 25% (n=1,0,0,0,1)
    0
    99999
    99999
    99999
    0
        Cycle 2 Day 8: >25% to 50% (n=1,0,0,0,1)
    0
    99999
    99999
    99999
    0
        Cycle 2 Day 8: >50% (n=1,0,0,0,1)
    0
    99999
    99999
    99999
    1
        Cycle 2 Day 15: No decline (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 2 Day 15: 0 to 25% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 2 Day 15: >25% to 50% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 2 Day 15: >50% (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    1
        Cycle 8 Day 15: No decline (n=0,0,1,0,0)
    99999
    99999
    1
    99999
    99999
        Cycle 8 Day 15: 0 to 25% (n=0,0,1,0,0)
    99999
    99999
    0
    99999
    99999
        Cycle 8 Day 15: >25% to 50% (n=0,0,1,0,0)
    99999
    99999
    0
    99999
    99999
        Cycle 8 Day 15: >50% (n=0,0,1,0,0)
    99999
    99999
    0
    99999
    99999
        EOT: No decline (n=7,19,19,4,3)
    7
    17
    19
    0
    0
        EOT: 0 to 25% (n=7,19,19,4,3)
    0
    2
    0
    0
    0
        EOT: >25% to 50% (n=7,19,19,4,3)
    0
    0
    0
    0
    0
        EOT: >50% (n=7,19,19,4,3)
    0
    0
    0
    4
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Change From Baseline in PSA Doubling Time (PSADT)

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    End point title
    		 Number of Subjects Reporting Change From Baseline in PSA Doubling Time (PSADT)
    End point description
    Subjects blood samples were tested for levels of PSA to track the progression of prostate cancer. PSADT was calculated using a linear regression model of the natural logarithm of PSA values and time. PSA doubling time compared to baseline during the treatment period for the following categories: 0 - 3 months; >3 - 6 months; >6 - 9 months; >9 – 12 months; >12 - 18 months; >18 - 24 months; >24 months and declining are reported in this endpoint. Analysis was performed on mITT population. Here, “number of subjects analysed” = subjects with available data for this endpoint and "n" signifies subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Cycle 4 Day 1, Cycle 8 Day 1, Cycle 12 Day 1 (each cycle duration=21 days)
    End point values
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Number of subjects analysed
    6
    21
    19
    5
    6
    Units: subjects
        Cycle 4 Day 1: 0 - 3 months (n=6,21,19,5,5)
    5
    16
    11
    1
    0
        Cycle 4 Day 1: >3 - 6 months (n=6,21,19,5,5)
    0
    2
    2
    0
    0
        Cycle 4 Day 1: >6 -9 months (n=6,21,19,5,5)
    1
    1
    2
    0
    0
        Cycle 4 Day 1: >9 -12 months (n=6,21,19,5,5)
    0
    0
    0
    0
    0
        Cycle 4 Day 1: >12 -18 months (n=6,21,19,5,5)
    0
    0
    0
    0
    0
        Cycle 4 Day 1: >18 -24 months (n=6,21,19,5,5)
    0
    0
    1
    0
    0
        Cycle 4 Day 1: >24 months (n=6,21,19,5,5)
    0
    0
    0
    0
    0
        Cycle 4 Day 1: Declining (n=6,21,19,5,5)
    0
    2
    3
    4
    5
        Cycle 8 Day 1: 0 - 3 months (n=4,13,15,5,6)
    3
    6
    8
    0
    0
        Cycle 8 Day 1: >3 - 6 months (n=4,13,15,5,6)
    0
    5
    1
    0
    0
        Cycle 8 Day 1: >6 - 9 months (n=4,13,15,5,6)
    0
    1
    0
    0
    0
        Cycle 8 Day 1: >9 - 12 months (n=4,13,15,5,6)
    0
    0
    2
    0
    0
        Cycle 8 Day 1: >12 - 18 months (n=4,13,15,5,6)
    0
    0
    1
    0
    0
        Cycle 8 Day 1: >18 - 24 months (n=4,13,15,5,6)
    0
    0
    0
    0
    0
        Cycle 8 Day 1: >24 months (n=4,13,15,5,6)
    1
    0
    1
    0
    0
        Cycle 8 Day 1: Declining (n=4,13,15,5,6)
    0
    1
    2
    5
    6
        Cycle 12 Day 1: 0 - 3 months (n=3,7,6,4,3)
    3
    2
    0
    0
    0
        Cycle 12 Day 1: >3 - 6 months (n=3,7,6,4,3)
    0
    3
    1
    0
    0
        Cycle 12 Day 1: >6 - 9 months (n=3,7,6,4,3)
    0
    1
    2
    0
    0
        Cycle 12 Day 1: >9 - 12 months (n=3,7,6,4,3)
    0
    0
    1
    0
    0
        Cycle 12 Day 1: >12 - 18 months (n=3,7,6,4,3)
    0
    0
    0
    0
    0
        Cycle 12 Day 1: >18 - 24 months (n=3,7,6,4,3)
    0
    0
    0
    0
    0
        Cycle 12 Day 1: >24 months (n=3,7,6,4,3)
    0
    0
    0
    0
    0
        Cycle 12 Day 1: Declining (n=3,7,6,4,3)
    0
    1
    2
    4
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With PSA Decline of >=50%

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    End point title
    		 Number of Subjects With PSA Decline of >=50%
    End point description
    Subjects blood samples were tested for levels of PSA to track the progression of prostate cancer. Subjects with PSA decline of >=50% compared to baseline according to PCWG3 (as reported by the investigator) are reported in this endpoint. Analysis was performed on mITT population. Here, “number of subjects analysed” = subjects with available data for this endpoint and "n" signifies subjects with available data for each specified category at respective visit and “99999” in the data field signifies that no subjects were available for analysis at the specified visit.
    End point type
    Secondary
    End point timeframe
    Day 8 (Cycles 1 and 2 only), Day 1 Cycle 2 and Day 15 (Cycles 1, 2 and 8 only) of each 21-day cycle, and EOT (up to 24 months)
    End point values
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Number of subjects analysed
    8
    24
    23
    5
    6
    Units: subjects
        Cycle 1 Day 8 (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 1 Day 15 (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    0
        Cycle 2 Day 1 (n=8,24,23,5,6)
    0
    0
    1
    3
    4
        Cycle 2 Day 8 (n=1,0,0,0,1)
    0
    99999
    99999
    99999
    1
        Cycle 2 Day 15 (n=0,0,0,0,1)
    99999
    99999
    99999
    99999
    1
        Cycle 8 Day 15 (n=0,0,1,0,0)
    99999
    99999
    0
    99999
    99999
        EOT (n=7,19,19,4,3)
    0
    0
    0
    4
    3
    No statistical analyses for this end point

    Secondary: Part 1: Objective Response Rate (ORR)

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    End point title
    		 Part 1: Objective Response Rate (ORR) [8]
    End point description
    ORR was defined as the percentage of subjects with a CR or PR as per PCWG3 criteria as determined by the investigator. Subjects not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to <10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to 27 weeks
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for Part 2: Arms 2 and 3.
    End point values
    		 Part 1 (mCRPC): BNT112
    Number of subjects analysed
    9
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Secondary: Part 2: Arms 2 and 3: Number of Subjects With Tumor Response Post-Treatment

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    End point title
    		 Part 2: Arms 2 and 3: Number of Subjects With Tumor Response Post-Treatment [9]
    End point description
    Best overall response was defined as single best response status at any tumor response assessment after first administration of IMP and prior to or at the start date of first subsequent anti-cancer therapy. Overall response of progressive disease within 14 days after the start date of first subsequent anti-cancer therapy was considered. The following order of tumor response categories were used, where “Complete Response” is best category: Complete Response (CR) – Partial Response (PR) – Stable Disease (SD) – Progressive Disease (PD) – Not Evaluable (NE) – Missing. CR: disappearance of all target lesions, with reduction in short axis to <10 mm in any pathological lymph nodes and no new lesions. PR:30% decrease in the sum of the longest diameter of target lesions. PD: progression of target lesions (sum of diameter increase to nadir of >=20% and by >=5 mm), progression of existing non-target lesions, or appearance of 1 or more new lesions.SD: no evidence of PD, CR or PR. mITT population.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to 25 weeks (Arm 2) and up to 26 weeks (Arm 3)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for Part 1 and Part 2: Arms 1a and 1b.
    End point values
    		 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Number of subjects analysed
    5
    6
    Units: subjects
        Complete Response (CR)
    0
    0
        Partial Response (PR)
    3
    3
        Stable Disease (SD)
    2
    2
        Progressive Disease (PD)
    0
    0
        Not Evaluable (NE)
    0
    0
        Missing
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to 30 days after last dose of BNT112 (Part 1 & Part 2 Arms 1b & 3), or up to 90 days after last dose of cemiplimab (Part 2: Arm 1a & Arm 2) (up to 4 years and 1 month)
    Adverse event reporting additional description
    Analysis was performed on safety set. 1 subject in Part 1 (mCRPC): BNT112 arm withdrew from study 13 days after receiving their last dose & is reported in participant flow section as having withdrawn from study (ITT population). The subject died within 30 days of their last dose so here included in the all-cause mortality count.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Part 1 (mCRPC): BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (mCRPC): Arm 1b: BNT112
    Reporting group description
    		 Subjects with mCRPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.

    Reporting group title
    Part 2 (LPC): Arm 2: BNT112 + Cemiplimab
    Reporting group description
    		 Subjects with high-risk, localised prostate cancer (LPC) received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Reporting group title
    Part 2 (LPC): Arm 3: BNT112
    Reporting group description
    		 Subjects with high-risk LPC received IV administration of BNT112 on Days 1, 8 and 15 of Cycle 1 and Cycle2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.

    Serious adverse events
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 9 (55.56%)
    5 / 28 (17.86%)
    9 / 27 (33.33%)
    2 / 5 (40.00%)
    2 / 6 (33.33%)
         number of deaths (all causes)
    7
    17
    13
    1
    0
         number of deaths resulting from adverse events
    2
    0
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    4 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1 (mCRPC): BNT112 Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Part 2 (mCRPC): Arm 1b: BNT112 Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Part 2 (LPC): Arm 3: BNT112
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    28 / 28 (100.00%)
    26 / 27 (96.30%)
    5 / 5 (100.00%)
    6 / 6 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 9 (44.44%)
    4 / 28 (14.29%)
    5 / 27 (18.52%)
    1 / 5 (20.00%)
    3 / 6 (50.00%)
         occurrences all number
    11
    6
    21
    1
    4
    Hot flush
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    0
    2
    2
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    3 / 27 (11.11%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    Flushing
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 9 (22.22%)
    10 / 28 (35.71%)
    5 / 27 (18.52%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    12
    6
    1
    2
    Chills
         subjects affected / exposed
    1 / 9 (11.11%)
    16 / 28 (57.14%)
    6 / 27 (22.22%)
    1 / 5 (20.00%)
    4 / 6 (66.67%)
         occurrences all number
    1
    39
    22
    1
    5
    Chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 28 (17.86%)
    5 / 27 (18.52%)
    3 / 5 (60.00%)
    2 / 6 (33.33%)
         occurrences all number
    10
    7
    9
    3
    2
    Asthenia
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    Pyrexia
         subjects affected / exposed
    6 / 9 (66.67%)
    17 / 28 (60.71%)
    16 / 27 (59.26%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    15
    31
    37
    3
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 28 (10.71%)
    2 / 27 (7.41%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    3
    2
    1
    1
    Injection site reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    5
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 28 (14.29%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    2
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 28 (10.71%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 28 (10.71%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 28 (14.29%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    4
    1
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    0
    2
    1
    2
    Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 28 (10.71%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    26
    0
    0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 28 (10.71%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    1
    0
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    0
    2
    Presyncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 28 (10.71%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    1
    1
    3
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 28 (10.71%)
    2 / 27 (7.41%)
    2 / 5 (40.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    7
    2
    4
    3
    Neuropathy peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 9 (44.44%)
    8 / 28 (28.57%)
    4 / 27 (14.81%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    5
    8
    4
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    0
    2
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
    6 / 28 (21.43%)
    6 / 27 (22.22%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    4
    11
    7
    2
    1
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 28 (10.71%)
    4 / 27 (14.81%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    6
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 28 (7.14%)
    3 / 27 (11.11%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    6
    4
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 28 (7.14%)
    6 / 27 (22.22%)
    0 / 5 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    3
    8
    0
    2
    Constipation
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 28 (7.14%)
    3 / 27 (11.11%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Pyelocaliectasis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    0
    1
    2
    Haematuria
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 28 (14.29%)
    6 / 27 (22.22%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    7
    1
    0
    Arthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    3
    0
    1
    Back pain
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 28 (14.29%)
    3 / 27 (11.11%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    4
    4
    1
    1
    Bone pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Gouty arthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    2
    Joint swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Mobility decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    4 / 27 (14.81%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    5
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 28 (14.29%)
    5 / 27 (18.52%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    5
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 28 (7.14%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 28 (3.57%)
    2 / 27 (7.41%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    3
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2019
    A new protocol template was implemented, and inconsistencies in the previous protocol version were corrected.
    05 Mar 2020
    The dose-limiting toxicity section was updated, and inconsistencies in the previous protocol version were corrected.
    01 Oct 2020
    Amendment 3 implemented primarily cemiplimab-relevant information and changes reflecting feedback from the pre-IND meeting with the US Food and Drug Administration (FDA) regarding the newly diagnosed localized prostate cancer clinical setting. The company product code BNT112 for BNT112 cancer vaccine was introduced. Also, information relevant to Part 2 was corrected and actualized including the dose range confirmation.
    06 Apr 2021
    Amendment 4 implemented the option for patients with mCRPC on BNT112 monotherapy to switch to cemiplimab monotherapy after disease progression. Additional changes were incorporated following regulatory agency feedback.
    23 Feb 2022
    Amendment 5 included the following substantial changes: Change of the immunogenicity secondary endpoint to an exploratory endpoint; Additional exclusion criterion regarding mentally incapacitated patients, as previously requested by the United States and German authorities; Schedule of Assessments was adapted to allow for additional blood draws at C1D8, C1D15, C2D8, and C2D15 for prostate-specific antigen level assessment. Other changes included a terminology change from W_pro1 to BNT112 and the correction of inconsistencies.

    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
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    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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