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    Clinical Trial Results:
    A multicenter, pilot study evaluating immune impact and safety of nivolumab in combination with ipilimumab (immune combination) before initial RT-CT treatment for cervix cancer. COLIBRI Study

    Summary
    EudraCT number
    		 2019-002271-34
    Trial protocol
    		 FR  
    Global end of trial date
    04 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2026
    First version publication date
    12 Feb 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GINECO-CE108b
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04256213
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ARCAGY-GINECO
    Sponsor organisation address
    8 Rue Lamennais, Paris, France, 75008
    Public contact
    Project Manager, Sidonie ADAM, ARCAGY-GINECO, 33 184 85 20 18, reglementaire@arcagy.org
    Scientific contact
    Project Manager, Sidonie ADAM, ARCAGY-GINECO, 33 184 85 20 18, reglementaire@arcagy.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Feb 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the evolution of the CD8+/FOXP3+ ratio of lymphocytes in pre- versus post-treatment biopsies in patients treated with a combination of Nivolumab and Ipilimumab in a window study, just before starting standard RT-CT.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements. Only patients who signed the written informed consent (including updated versions and addenda) were included in the study. Before the enrollment of any patient, the final study protocol and informed consent were approved by the the comptent authority, the French National Agency for Medicines and Health Products Safety (ANSM), on 23/10/2019 and the assigned Etthics committte (Comité de Protection des Personnes, CPP) on 04/12/2019. Before the implementation of any modifications to the approved study protocol, informed consent and / or any other study documents, the approval of the Ethics committee and the comptente authority were acquired.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 40 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 40
    Worldwide total number of subjects
    40
    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)
    32
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment period: Country: France

    Pre-assignment
    Screening details
    		 Screening assessments conducted within 28 days before treatment initiation include a complete physical and gynecological examination, ECOG performance status, vital signs, and evaluation of clinical signs and symptoms, with particular focus on enterocolitis, dermatitis, neuropathy, and endocrinopathy.

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab, 3mg/kg, administered as a 30 minutes IV infusion on day 1 and day 15 of the induction period (Cycle 1). Nivolumab injection is to be administered as an IV infusion through a 0.2-micron to 1.2-micron pore size, low-protein binding (polyethersulfone membrane) in-line filter at the protocol-specified doses and infusion times. It is not to be administered as an IV push or bolus injection. When the dose is based on patient weight (ie, mg/kg), nivolumab injection can be infused undiluted (10 mg/mL) or diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to protein concentrations as low as 0.35 mg/mL.

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab, 1mg/kg, is to be administered as a 30 minutes IV infusion on Day 1 of the induction period (Cycle 1). Ipilimumab injection (5 mg/mL) is to be administered as an intravenous (IV) infusion without dilution after transferring to a polyvinyl chloride (PVC), non PVC/non di (2 ethylhexyl) phthalate (DEHP), or glass container and is stable for 24 hours at 2°C to 8°C or room temperature/room light. Ipilimumab injection must not be administered as an IV push or bolus injection. Ipilimumab injection may be diluted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to concentrations between 1 mg/mL and 4 mg/mL and store On Day 1 of Cycle 1, both nivolumab and ipilimumab are administered. Separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first and then promptly followed by a saline flush to clear the line before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes.

    Number of subjects in period 1
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40
    Period 2
    Period 2 title
    Induction
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab, 3mg/kg, administered as a 30 minutes IV infusion on day 1 and day 15 of the induction period (Cycle 1). Nivolumab injection is to be administered as an IV infusion through a 0.2-micron to 1.2-micron pore size, low-protein binding (polyethersulfone membrane) in-line filter at the protocol-specified doses and infusion times. It is not to be administered as an IV push or bolus injection. When the dose is based on patient weight (ie, mg/kg), nivolumab injection can be infused undiluted (10 mg/mL) or diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to protein concentrations as low as 0.35 mg/mL.

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab, 1mg/kg, is to be administered as a 30 minutes IV infusion on Day 1 of the induction period (Cycle 1). Ipilimumab injection (5 mg/mL) is to be administered as an intravenous (IV) infusion without dilution after transferring to a polyvinyl chloride (PVC), non PVC/non di (2 ethylhexyl) phthalate (DEHP), or glass container and is stable for 24 hours at 2°C to 8°C or room temperature/room light. Ipilimumab injection must not be administered as an IV push or bolus injection. Ipilimumab injection may be diluted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to concentrations between 1 mg/mL and 4 mg/mL and store On Day 1 of Cycle 1, both nivolumab and ipilimumab are administered. Separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first and then promptly followed by a saline flush to clear the line before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes.

    Number of subjects in period 2
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40
    Period 3
    Period 3 title
    RT-CT
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab, 3mg/kg, administered as a 30 minutes IV infusion on day 1 and day 15 of the induction period (Cycle 1). Nivolumab injection is to be administered as an IV infusion through a 0.2-micron to 1.2-micron pore size, low-protein binding (polyethersulfone membrane) in-line filter at the protocol-specified doses and infusion times. It is not to be administered as an IV push or bolus injection. When the dose is based on patient weight (ie, mg/kg), nivolumab injection can be infused undiluted (10 mg/mL) or diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to protein concentrations as low as 0.35 mg/mL.

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab, 1mg/kg, is to be administered as a 30 minutes IV infusion on Day 1 of the induction period (Cycle 1). Ipilimumab injection (5 mg/mL) is to be administered as an intravenous (IV) infusion without dilution after transferring to a polyvinyl chloride (PVC), non PVC/non di (2 ethylhexyl) phthalate (DEHP), or glass container and is stable for 24 hours at 2°C to 8°C or room temperature/room light. Ipilimumab injection must not be administered as an IV push or bolus injection. Ipilimumab injection may be diluted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to concentrations between 1 mg/mL and 4 mg/mL and store On Day 1 of Cycle 1, both nivolumab and ipilimumab are administered. Separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first and then promptly followed by a saline flush to clear the line before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes.

    Number of subjects in period 3
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40
    Period 4
    Period 4 title
    Delay of 4-6 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab, 3mg/kg, administered as a 30 minutes IV infusion on day 1 and day 15 of the induction period (Cycle 1). Nivolumab injection is to be administered as an IV infusion through a 0.2-micron to 1.2-micron pore size, low-protein binding (polyethersulfone membrane) in-line filter at the protocol-specified doses and infusion times. It is not to be administered as an IV push or bolus injection. When the dose is based on patient weight (ie, mg/kg), nivolumab injection can be infused undiluted (10 mg/mL) or diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to protein concentrations as low as 0.35 mg/mL.

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab, 1mg/kg, is to be administered as a 30 minutes IV infusion on Day 1 of the induction period (Cycle 1). Ipilimumab injection (5 mg/mL) is to be administered as an intravenous (IV) infusion without dilution after transferring to a polyvinyl chloride (PVC), non PVC/non di (2 ethylhexyl) phthalate (DEHP), or glass container and is stable for 24 hours at 2°C to 8°C or room temperature/room light. Ipilimumab injection must not be administered as an IV push or bolus injection. Ipilimumab injection may be diluted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to concentrations between 1 mg/mL and 4 mg/mL and store On Day 1 of Cycle 1, both nivolumab and ipilimumab are administered. Separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first and then promptly followed by a saline flush to clear the line before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes.

    Number of subjects in period 4
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40
    Period 5
    Period 5 title
    Maintenance
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the maintenance phase, nivolumab 480 mg will be administered Q4W for 6 months At day 1 of the maintenance phase, Nivolumab 480 mg should be administered as a 60 minutes IV infusion. At the next administrations (C3D1 to C7D1), Nivolumab may be administered as a 30 minutes IV infusion if there was no infusion-related reaction during the previous infusion.

    Number of subjects in period 5
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40
    Period 6
    Period 6 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Nivolumab + Ipilimumab
    Arm description
    		 -
    Arm type
    		 Follow-up

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 6
    		Nivolumab + Ipilimumab
    Started
    40
    Completed
    40

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 -

    Reporting group values
    		 Screening Total
    Number of subjects
    		 40 40
    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)
    		 20 20
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 55 (31 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 40 40
        Male
    		 0 0
    ECOG
    Units: Subjects
        Zero
    		 26 26
        One
    		 14 14
        Two
    		 0 0
        Three
    		 0 0
        Four
    		 0 0
        Five
    		 0 0
    Aspect of the cervix
    Units: Subjects
        Normal
    		 4 4
        Ulcered
    		 9 9
        Infilterating
    		 10 10
        Vegetating
    		 6 6
        Missing data
    		 11 11
    Aspect of the vaginal fornix
    Units: Subjects
        Normal
    		 12 12
        Infiltrating
    		 15 15
        Missing data
    		 13 13
    Cervix maximal diameter
    Units: Subjects
        40
    		 4 4
        45
    		 3 3
        50
    		 6 6
        51
    		 1 1
        55
    		 1 1
        60
    		 3 3
        70
    		 1 1
        80
    		 2 2
        Missing data
    		 19 19
    Parametrial infilteration
    Units: Subjects
        No
    		 5 5
        Yes
    		 18 18
        Missing data
    		 17 17
    Adnexa
    Units: Subjects
        Missing data
    		 23 23
        Normal
    		 17 17
    Lymph nodes
    Units: Subjects
        Normal
    		 37 37
        Not done
    		 2 2
        Missing data
    		 1 1
    Abdomen
    Units: Subjects
        Abnormal (Sensible and Pain)
    		 1 1
        Normal
    		 37 37
        Not done
    		 1 1
        Missing data
    		 1 1
    Lumbar fossa
    Units: Subjects
        Abnormal (Pain left lumbar)
    		 1 1
        Normal
    		 31 31
        Not done
    		 7 7
        Missing data
    		 1 1
    HIV antibody
    Units: Subjects
        Negative
    		 38 38
        Unknown
    		 2 2
    HIV Antigen
    Units: Subjects
        Negative
    		 37 37
        Unknown
    		 3 3
    HBs antigen
    Units: Subjects
        Negative
    		 40 40
    HBc antibody
    Units: Subjects
        Negative
    		 37 37
        Positive
    		 3 3
    HCV antibody
    Units: Subjects
        Negative
    		 37 37
        Positive
    		 2 2
        Unknown
    		 1 1
    HCV RNA
    Units: Subjects
        Not detected
    		 18 18
        Unknown
    		 22 22
    Medical history - Cardiac disorders
    Units: Subjects
        Mitral valve incompetence
    		 1 1
        Rest
    		 39 39
    Medical history - Congenital, familial and genetic disorders
    Units: Subjects
        Syringomyelia
    		 1 1
        Rest
    		 39 39
    Medical history - Ear and labyrinth disorders
    Units: Subjects
        Deafness
    		 1 1
        Rest
    		 39 39
    Medical history - Eye disorders
    Units: Subjects
        Eye disorder
    		 1 1
        Rest
    		 39 39
    Medical History - Eye disorders
    Units: Subjects
        Glaucoma
    		 3 3
        Rest
    		 37 37
    Medical History - Eye disorders
    Units: Subjects
        Ocular hypertension
    		 1 1
        rest
    		 39 39
    Medical History - Eye disorders
    Units: Subjects
        Retinal vascular disorders
    		 1 1
        Rest
    		 39 39
    Medical History - Gastrointestinal disorders
    Units: Subjects
        Abdominal pain
    		 1 1
        Rest
    		 39 39
    Medical History - Gastrointestinal disorders
    Units: Subjects
        Constipation
    		 1 1
        Rest
    		 39 39
    Medical History - Gastrointestinal disorders
    Units: Subjects
        Diarrhea
    		 1 1
        Rest
    		 39 39
    Medical history - Gastrointestinal disorders
    Units: Subjects
        Gastroesophageal reflux disease
    		 1 1
        Rest
    		 39 39
    Medical history - Gastrointestinal disorders
    Units: Subjects
        Inguinal hernia
    		 1 1
        Rest
    		 39 39
    Medical history - Gastrointestinal disorders
    Units: Subjects
        Volvulus
    		 1 1
        Rest
    		 39 39
    Medical history - Hepatobiliary diosrders
    Units: Subjects
        Cholelithiasis
    		 1 1
        Rest
    		 39 39
    Medical history - Hepatobiliary diosrders
    Units: Subjects
        Hepatitis
    		 1 1
        Rest
    		 39 39
    Medical history - Immune system diosrders
    Units: Subjects
        Drug hypersensitivity
    		 1 1
        Rest
    		 39 39
    Medical history - Immune system disorders
    Units: Subjects
        Hypersensitivity
    		 2 2
        Rest
    		 38 38
    Medical history - Infections and infestations
    Units: Subjects
        Bronchitis
    		 1 1
        Rest
    		 39 39
    Medical history - Infections and infestations
    Units: Subjects
        Hepatitis C
    		 1 1
        Rest
    		 39 39
    Medical history - Infections and infestations
    Units: Subjects
        Pilonidal cyst
    		 1 1
        Rest
    		 39 39
    Medical histoy - Infections and infestations
    Units: Subjects
        Pyelonephritis
    		 1 1
        Rest
    		 39 39
    Medical history - Infections and infestations
    Units: Subjects
        Syphilis
    		 1 1
        Rest
    		 39 39
    Medical history - Infections and infestations
    Units: Subjects
        Urinary tract infection
    		 1 1
        Rest
    		 39 39
    Medical History - Injury, poisoning and procedural complications
    Units: Subjects
        Spinal compression fracture
    		 1 1
        Rest
    		 39 39
    Medical history - Investigations
    Units: Subjects
        Lipase increased
    		 1 1
        Rest
    		 39 39
    Medical history - Metabolism and Nutrition disorders
    Units: Subjects
        Diabetes Mellitus
    		 2 2
        Rest
    		 38 38
    Medical history - Metabolism and nutrition disorders
    Units: Subjects
        Dyslipidemia
    		 3 3
        Rest
    		 37 37
    Medical history - Metabolism and nutrition disorders
    Units: Subjects
        Hypercholesterolemia
    		 1 1
        Rest
    		 39 39
    Medical history - Metabolism and nutrition disorders
    Units: Subjects
        Obesity
    		 1 1
        Rest
    		 39 39
    Medical history - Metabolism and nutrition disorders
    Units: Subjects
        Type 2 Diabetes Mellitus
    		 1 1
        Rest
    		 39 39
    Medical history - Mucoskeletal and connective tissue disorders
    Units: Subjects
        Arthralgia
    		 1 1
        Rest
    		 39 39
    Medical history - Mucoskeletal and connective tissue disorders
    Units: Subjects
        Back pain
    		 2 2
        Rest
    		 38 38
    Medical history - Mucoskeletal and connective tissue disorders
    Units: Subjects
        Fibromyalgia
    		 1 1
        Rest
    		 39 39
    Medical history - Musculoskeletal and connective tissue disorders
    Units: Subjects
        Osteoarthritis
    		 2 2
        Rest
    		 38 38
    Medical history - Musculoskeletal and connective tissue disorders
    Units: Subjects
        Osteoporosis
    		 3 3
        Rest
    		 37 37
    Medical history - Musculoskeletal and connective tissue disorders
    Units: Subjects
        Rheumatoid arthritis
    		 1 1
        Rest
    		 39 39
    Medical history - Musculoskeletal and connective tissue disorders
    Units: Subjects
        Scoliosis
    		 1 1
        Rest
    		 39 39
    Medical History - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
    Units: Subjects
        ANOGENITAL WARTS
    		 1 1
        Rest
    		 39 39
    Medical HIstory - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
    Units: Subjects
        MALIGNANT MELANOMA
    		 1 1
        Rest
    		 39 39
    Medical History - PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS
    Units: Subjects
        ECTOPIC PREGNANCY
    		 1 1
        Rest
    		 39 39
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        ANXIETY
    		 1 1
        Rest
    		 39 39
    Medical HIstory - PSYCHIATRIC DISORDERS
    Units: Subjects
        BIPOLAR DISORDER
    		 1 1
        Rest
    		 39 39
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        DEPRESSION
    		 2 2
        Rest
    		 38 38
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        DEPRESSION
    		 2 2
        Rest
    		 38 38
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        DRUG DEPENDENCE
    		 1 1
        Rest
    		 39 39
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        INSOMNIA
    		 1 1
        Rest
    		 39 39
    Medical History - PSYCHIATRIC DISORDERS
    Units: Subjects
        NICOTINE DEPENDENCE
    		 1 1
        Rest
    		 39 39
    Medical History - RENAL AND URINARY DISORDERS
    Units: Subjects
        HYDRONEPHROSIS
    		 1 1
        Rest
    		 39 39
    Medical History - RENAL AND URINARY DISORDERS
    Units: Subjects
        NEPHROLITHIASIS
    		 1 1
        Rest
    		 39 39
    Medical History - RENAL AND URINARY DISORDERS
    Units: Subjects
        POLLAKIURIA
    		 1 1
        Rest
    		 39 39
    Medical History - RENAL AND URINARY DISORDERS
    Units: Subjects
        RENAL FAILURE
    		 1 1
        Rest
    		 39 39
    Medical Hiistory - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        BREAST CYST
    		 1 1
        Rest
    		 39 39
    Medical History - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        CERVIX HAEMORRHAGE UTERINE
    		 1 1
        Rest
    		 39 39
    Medical History - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        ENDOMETRIOSIS
    		 2 2
        Rest
    		 38 38
    Medical History - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        OVARIAN CYST
    		 1 1
        Rest
    		 39 39
    Medical History - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        PELVIC PAIN
    		 5 5
        Rest
    		 35 35
    Medical HIstory - REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    Units: Subjects
        PERINEAL DISORDER
    		 1 1
        Rest
    		 39 39
    Medical History - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    Units: Subjects
        ASTHMA
    		 1 1
        Rest
    		 39 39
    Medical History - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    Units: Subjects
        CHRONIC OBSTRUCTIVE PULMONARY DISEASE
    		 3 3
        Rest
    		 37 37
    Medical History - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    Units: Subjects
        EMPHYSEMA
    		 1 1
        Rest
    		 39 39
    Medical History - SOCIAL CIRCUMSTANCES
    Units: Subjects
        TOBACCO USER
    		 11 11
        Rest
    		 29 29
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        APPENDICECTOMY
    		 8 8
        Rest
    		 32 32
    Medical History -
    Units: Subjects
        BONE OPERATION
    		 1 1
        Rest
    		 39 39
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        CERVICAL CONISATION
    		 5 5
        Rest
    		 35 35
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        CHOLECYSTECTOMY
    		 4 4
        Rest
    		 36 36
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        HIP ARTHROPLASTY
    		 1 1
        Rest
    		 39 39
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        MAMMOPLASTY
    		 2 2
        Rest
    		 38 38
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        MYOPIA CORRECTION
    		 1 1
        Rest
    		 39 39
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        NASAL POLYPECTOMY
    		 1 1
        Rest
    		 39 39
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        PLASTIC SURGERY
    		 1 1
        Rest
    		 39 39
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        THYROIDECTOMY
    		 3 3
        Rest
    		 37 37
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        TONSILLECTOMY
    		 3 3
        Rest
    		 37 37
    Medical History - SURGICAL AND MEDICAL PROCEDURES
    Units: Subjects
        VARICOSE VEIN OPERATION
    		 1 1
        Rest
    		 39 39
    Medical History - VASCULAR DISORDERS
    Units: Subjects
        HYPERTENSION
    		 9 9
        Rest
    		 31 31
    Medical History - VASCULAR DISORDERS
    Units: Subjects
        VARICOSE VEIN
    		 1 1
        Rest
    		 39 39
    Medical History - NERVOUS SYSTEM DISORDERS
    Units: Subjects
        CARPAL TUNNEL SYNDROME
    		 1 1
        Rest
    		 39 39
    Medical History - NERVOUS SYSTEM DISORDERS
    Units: Subjects
        EPILEPSY
    		 1 1
        Rest
    		 39 39
    Medical History - NERVOUS SYSTEM DISORDERS
    Units: Subjects
        MIGRAINE
    		 1 1
        Rest
    		 39 39
    Medical History - NERVOUS SYSTEM DISORDERS
    Units: Subjects
        SCIATICA
    		 1 1
        Rest
    		 39 39
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 62.7 ( 11.4 ) -
    Systolic blood pressure
    Units: millimetre(s) of mercury
        arithmetic mean (standard deviation)
    		 133.9 ( 19.4 ) -
    Diastolic blood pressure
    Units: Millimetres(s) of mercury
        arithmetic mean (standard deviation)
    		 78.5 ( 11.8 ) -
    Cardiac frequency
    Units: Beats per minute
        arithmetic mean (standard deviation)
    		 85.2 ( 16.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -

    Primary: CD8+/FOXP3+ relative change of lymphocytes before and after the induction

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    End point title
    		 CD8+/FOXP3+ relative change of lymphocytes before and after the induction [1]
    End point description
    End point type
    Primary
    End point timeframe
    Induction
    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: The statistical analysis of the primary endpoint was only descriptive.
    End point values
    		 Nivolumab + Ipilimumab
    Number of subjects analysed
    40
    Units: N/A
        arithmetic mean (standard deviation)
    2.57 ( 6.46 )
    No statistical analyses for this end point

    Secondary: Overall disease response evaluated based on RECIST 1.1 criteria

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    End point title
    		 Overall disease response evaluated based on RECIST 1.1 criteria
    End point description
    End point type
    Secondary
    End point timeframe
    Induction (1 week before RT-CT) 4 weeks after RT-CT End of treatment visit (At the end of the maintenance phase)
    End point values
    		 Nivolumab + Ipilimumab Nivolumab + Ipilimumab Nivolumab + Ipilimumab
    Number of subjects analysed
    40
    40
    40
    Units: Participants
        Partial response
    5
    0
    7
        Stable disease
    33
    1
    0
        Progressive disease
    2
    15
    4
        Complete response
    0
    24
    29
    No statistical analyses for this end point

    Secondary: Overall response rate evaluated based on RECIST 1.1 stratified by patient’s FIGO stage (Figo I and II)

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    End point title
    		 Overall response rate evaluated based on RECIST 1.1 stratified by patient’s FIGO stage (Figo I and II)
    End point description
    End point type
    Secondary
    End point timeframe
    Induction (1 week before RT-CT) Maintenance End of treatment visit
    End point values
    		 Nivolumab + Ipilimumab Nivolumab + Ipilimumab Nivolumab + Ipilimumab
    Number of subjects analysed
    14
    14
    14
    Units: Participants
        Complete response
    0
    10
    11
        Partial response
    1
    4
    3
        Stable disease
    11
    0
    0
        Progressive disease
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Overall response rate evaluated based on RECIST 1.1 stratified by patient’s FIGO stage (III and IV)

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    End point title
    		 Overall response rate evaluated based on RECIST 1.1 stratified by patient’s FIGO stage (III and IV)
    End point description
    End point type
    Secondary
    End point timeframe
    Induction 4 weeks after RT-CT End of treatment of visit
    End point values
    		 Nivolumab + Ipilimumab Nivolumab + Ipilimumab Nivolumab + Ipilimumab
    Number of subjects analysed
    26
    26
    26
    Units: Participants
        Complete response
    0
    14
    18
        Partial response
    4
    11
    4
        Stable disease
    22
    1
    0
        Progressive disease
    0
    0
    4
    No statistical analyses for this end point

    Secondary: 1-year progression free survival

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    End point title
    		 1-year progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Follow-up (1 year from inclusion)
    End point values
    		 Nivolumab + Ipilimumab
    Number of subjects analysed
    40
    Units: Participants
        Progression
    4
        No progression
    36
    No statistical analyses for this end point

    Secondary: 3-year overall survival

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    End point title
    		 3-year overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Follow-up (3 years from inclusion)
    End point values
    		 Nivolumab + Ipilimumab
    Number of subjects analysed
    40
    Units: Participants
        Alive
    36
        Dead
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported during the induction, RT-CT, and maintenance phases.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Nivolumab + Ipilimumab
    Reporting group description
    		 -

    Serious adverse events
    		 Nivolumab + Ipilimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 40 (15.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    UROSTOMY COMPLICATION
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    LOSS OF CONSCIOUSNESS
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    HYPERSENSITIVITY
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    HYPOTHYROIDISM
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    		 Nivolumab + Ipilimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    Vascular disorders
    LYMPHOEDEMA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Lymphocele
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Hot flush
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    25 / 40 (62.50%)
         occurrences all number
    46
    PYREXIA
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    FATIGUE
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    8
    Oedema
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Hyperthermia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Vaccination site reaction
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Reproductive system and breast disorders
    GENITAL HAEMORRHAGE
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    VULVOVAGINAL PAIN
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    METRORRHAGIA
         subjects affected / exposed
    9 / 40 (22.50%)
         occurrences all number
    10
    VAGINAL DISCHARGE
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    PELVIC PAIN
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    Vulvovaginal inflammation
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Uterine adhesions
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Vulval eczema
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    EPISTAXIS
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    COUGH
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Dysphonia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Anxiety
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Investigations
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    6
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Radiation vulvovaginitis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Radiation skin injury
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Cardiac disorders
    TACHYCARDIA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    PARAESTHESIA
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    SCIATICA
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Neuropathy peripheral
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Presyncope
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    ANAEMIA
         subjects affected / exposed
    22 / 40 (55.00%)
         occurrences all number
    27
    Lymphopenia
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    13
    Neutropenia
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Thrombocytopenia
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    13
    Leukopenia
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    10
    Ear and labyrinth disorders
    TINNITUS
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Hypoacusis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Eye disorders
    XEROPHTHALMIA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    28 / 40 (70.00%)
         occurrences all number
    35
    CONSTIPATION
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    15
    Nausea
         subjects affected / exposed
    23 / 40 (57.50%)
         occurrences all number
    25
    Abdominal pain
         subjects affected / exposed
    9 / 40 (22.50%)
         occurrences all number
    10
    Abdominal pain upper
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Proctalgia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    6
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Abdominal rigidity
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Rectal tenesmus
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    6
    PRURITUS
         subjects affected / exposed
    10 / 40 (25.00%)
         occurrences all number
    10
    URTICARIA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    XERODERMA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    RASH ERYTHEMATOUS
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    ERYTHEMA
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Onycholysis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Alopecia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Renal and urinary disorders
    RENAL IMPAIRMENT
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Pollakiuria
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    9
    Stress urinary incontinence
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Urinary tract disorder
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Renal failure
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Urinary tract discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Endocrine disorders
    HYPERTHYROIDISM
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    7
    Hypothyroidism
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    14
    Anorectal discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Flank pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Oral fungal infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    6
    Oral candidiasis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Acinetobacter infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 40 (22.50%)
         occurrences all number
    10
    Hyperkalaemia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Cell death
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Hyperglycaemia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Hypercreatininaemia
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Aug 2020
    - Modification or correction of selection criteria, - Modification of the description of secondary endpoints analyses and efficacy assessments - Corrections to typographical errors and discrepancies between the summary and the protocol and/or the Investigator’s brochure - Modification of the composition of the steering committee - Administrative update
    26 Jan 2021
    - Modification of the infusion duration for Nivolumab 480 mg at C2D1 and subsequent administrations if necessary
    20 Aug 2021
    Appendix 3 and 4 updated according to the Nivolumab IB v20 and Ipilimumab IB v24 - Administrative update: change of biostatistician
    04 Jul 2022
    Modification of the patient participation and the definition of the end of the study

    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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