Clinical Trials Register

Summary
EudraCT Number:	2016-001928-54
Sponsor's Protocol Code Number:	CA209-650
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-06-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-001928-54

A.3

Full title of the trial

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Sperimentazione di fase 2 su nivolumab più ipilimumab, ipilimumab in monoterapia o cabazitaxel in uomini con carcinoma prostatico metastatico resistente alla castrazione

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men, with Metastatic Castration-Resistant Prostate Cancer

Uno studio di Nivolumab più Ipilimumab, Ipilimumab o cabazitaxel in uomini con carcinoma prostatico metastatico resistente alla castrazione.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CA209-650

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02985957

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1182-4341

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	900150160
B.5.6	E-mail	clinical.trials@bms.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ipilimumab
D.3.2	Product code	[BMS-734016]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ipilimumab
D.3.9.1	CAS number	477202-00-9
D.3.9.2	Current sponsor code	BMS-734016
D.3.9.3	Other descriptive name	BMS734016
D.3.9.4	EV Substance Code	SUB22577
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	JEVTANA 60 mg concentrate and solvent for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis groupe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cabazitaxel concentrate
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Powder and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CABAZITAXEL
D.3.9.1	CAS number	183133-96-2
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB31282
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Opdivo (100 mg/10 ml)
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NIVOLUMAB - 10ml vial-commercial
D.3.2	Product code	[BMS-936558]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nivolumab
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558
D.3.9.3	Other descriptive name	BMS936558
D.3.9.4	EV Substance Code	SUB32944
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Opdivo (40 mg/4 ml)
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NIVOLUMAB-4 ml vial - COMMERCIAL
D.3.2	Product code	[BMS-936558]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nivolumab
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558
D.3.9.3	Other descriptive name	BMS936558
D.3.9.4	EV Substance Code	SUB32944
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Prednison HEXAL
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Prednison HEXAL 5 mg
D.3.2	Product code	[ooo]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PREDNISONE
D.3.9.2	Current sponsor code	ooo
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic Castration-Resistant Prostate Cancer

Carcinoma metastatico alla prostata resistente alla castrazione

E.1.1.1

Medical condition in easily understood language

Metastatic Castration-Resistant Prostate Cancer

Carcinoma metastatico alla prostata resistente alla castrazione

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

- Evaluate objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 assessed by Blinded Independent Central Review (BICR) in subjects with mCRPC and measurable disease at baseline.
- Assess Radiographic Progression Free Survival (rPFS) assessed by BICR in all treated subjects with mCRPC using RECIST V1.1 for soft tissue disease progression and PCWG2 for bone disease progression.

• Valutare il tasso di risposta obiettiva (Objective Response Rate, ORR) secondo i Criteri di valutazione della risposta nei tumori solidi (Response Evaluation Criteria in Solid Tumors, RECIST) v1.1, in base alla valutazione mediante revisione centrale indipendente in cieco (Blinded Independent Central Review, BICR) in soggetti con mCRPC e malattia misurabile al basale.
• Valutare la sopravvivenza libera da progressione radiografica (radiographic Progression Free Survival, rPFS) valutata mediante BICR in tutti i soggetti trattati con mCRPC secondo i criteri RECIST v1.1 per la progressione della malattia a carico dei tessuti molli e i criteri del Prostate Cancer Clinical Trials Working Group 2 (PCWG2) per la progressione della malattia ossea

E.2.2

Secondary objectives of the trial

- Assess radiographic/clinical Progression Free Survival (rcPFS)
- Assess overall survival (OS).
- Evaluate PSA response rate (PSA-RR)
- Determine the safety and tolerability in all treated subjects .
- Estimate changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)
- Estimate changes in cancer-related symptoms and quality of life (QoL) using the FACT-P questionnaire
- Estimate changes in health status and health utility as measured by the 3-level EQ-5D-3L questionnaire

• Valutare sopravvivenza libera da progressione radiografica/clinica (radiographic/clinical Progression Free Survival, rcPFS)
• Valutare sopravvivenza globale (Overall Survival, OS)
• Valutare tasso risposta antigene prostatico specifico (Prostate-Specific Antigen-Response Rate, PSA-RR)
• Determinare sicurezza e tollerabilità in tutti i soggetti trattati
• Stimare variazioni nel dolore misurate mediante questionario breve per valutazione dolore (Brief Pain Inventory-Short Form, BPI-SF)
• Stimare variazioni nei sintomi correlati al tumore e nella qualità della vita (Quality of Life, QoL) utilizzando questionario valutazione funzionale terapia antitumorale pazienti affetti da carcinoma prostatico (Functional Assessment of Cancer Therapy-Prostate, FACT-P) (solo nella Coorte D)
• Stimare variazioni stato salute e nell’utilizzo risorse sanitarie come misurate mediante questionario europeo su qualità della vita a 5 dimensioni e 3 livelli (EuroQoL 5 Dimensions 3 Levels, EQ-5D-3L).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-ECOG performance status 0-1
- Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL).
For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

-ECOG 0-1
-Evidenza corrente di malattia metastatica dcoumentata tramite lesioni ossee valutate con scintigrafia ossea e/o lesioni dei tessuti molli valutate con tomografia computerizzata/ risonanza magnetica (CT/MRI)
-Terapia di deprivazione androgenica (Androgen Deprivation Therapy, ADT) in corso con
un analogo dell’ormone di rilascio delle gonadotropine (Gonadotropin-Releasing Hormone,
GnRH) o orchiectomia bilaterale (ovvero, castrazione medica o chirurgica) confermata da
livelli di testosterone <=1,73 nmol/l (50 ng/dl) alla visita di screening
Per la fase di Cross-over per i soggetti randomizzati originariamente al Braccio D3 o Braccio D4: conferma istologica di adenocarcinoma della prostata ed evidenza di malattia allo stadio IV( definita secondo i criteri dell’ American Joint Committee on Cancer, (AJCC), 8° edizione) prima della randomizzazione

E.4

Principal exclusion criteria

- Presence of visceral metastases in the liver
- Active brain metastases or leptomeningeal metastases
- Active, known, or suspected autoimmune disease or infection
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab.
- Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).

- Metastasi viscerali nel fegato
-Metastasi attive al cervello o leptominengee
- Attiva, conosciuta o sospetta malattina on infezione autoimmune
-Precedente trattamento con un anticorpo anti-PD1, anti-PD-L1, anti-PD-L2, o anti CTLA-4, o qualsiasi altro anticorpo o farmaco che agisce in maniera specifica sui pathway di check-point o di co-stimolazione delle cellule T
Per la fase di Cross-over per i soggetti randomizzati originariamente al Braccio D3 o Braccio D4:
-Precedente radioterapia entro 14 giorni dal prima dose di nivolumab in combinazione con ipilimumab
-Che hanno ricevuto una terapia sistemica anticancro dopo l’ultima dose del farmaco in studio (ipilimumab o cabazitaxel)

E.5 End points

E.5.1

Primary end point(s)

1) Objective Response Rate (ORR) in Cohort B, C, and Cohort D - Part 2
2) Objective Response Rate (ORR) in Cohort D - Part 1 period 3/Radiographic Progression-Free Survival (rPFS)
3) Radiographic Progression-Free Survival (rPFS)

1) Il tasso di risposta obiettiva (ORR) nella coorte B,C nella coorte D-Parte2
2) Il tasso di risposta obiettiva (ORR) nella coorte D-Parte 1
3) La sopravvivenza libera da progressione radiografica (rPFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

1) Approximately 24 weeks from treatment initiation
2) Approximately 24 weeks from treatment initiation
3) Approximately 12 months from treatment initiation

1) Circa 24 Settimane dall’inizio del trattamento
2) Circa 24 Settimane dall’inizio del trattamento
3) Circa 12 mesi dall’inizio del trattamento

E.5.2

Secondary end point(s)

1/Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B,C, and Cohort D - Part 2 period
2/Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period
3/Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period
4/Overall Survival (OS) in Cohort D - Part 1 period
5/Incidence of Adverse Events (AEs)
6/Incidence of Serious Adverse Events (SAEs)
7/Incidence of Adverse Events (AEs) leading to discontinuation
8/Incidence of Immune-mediated Adverse Events (IMAEs)
9/Incidence of deaths
10/Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function
11/Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)
12/Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L)
13/Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire
14/Prostate Specfic Antigen (PSA) Response Rate; 1) La sopravvivenza libera da progressione radiografica/clinica (rcPFS) nella Coorte B, C, e Coorte D-Parte 2
2) La sopravvivenza libera da progressione radiografica/clinica (rcPFS) nella Coorte D-Parte 1
3) Sopravvivenza globale (OS) nella Coorte B, C, e Coorte D-Parte 2
4) Sopravvivenza globale (OS) nella Coorte D-Parte 1
5) Incidenza degli eventi avversi (AEs)
6) Incidenza degli eventi avversi seri (SAEs)
7) Incidenza di eventi avversi (AEs) che portano alla discontinuazione
8) Incidenza degli eventi avversi immuno-mediati (IMAEs)
9) Incidenza dei decessi
10) Incidenza di test di laboratorio non nella norma: Hematologia, Chimica Clinica, Coagulazione, Funzione epatica, Funzione tiroidea, Funzione surrenale, Funzione renale
11) Numero di soggetti con modifiche del dolore misurabili tramite Brief Pain Inventory- Short Form ( BPI-SF)
12) Cambiamenti misurabili dello stato di salute e qualità della vita, utilizzando il 3-level EuroQol Five Dimension (EQ-5D-3L)
13) Modifiche dei sintomi correlati alla malattia e qualità della vita utilizzando il Functional Assessmnent Of Cancer Therapy- Prostate questionario (FACT-P)
14) Tassi di risposta del Prostate Specific Antigen (PSA)

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Approximately 12 months from treatment initiation
2) Approximately 12 months from randomization
3) Up to 5 years from treatment initiation
4) Up to 5 years from randomization
5-10) From first dose up to and including 100 days post last dose
11) Approximately 12 months from treatment initiation
12) Approximately 12 months from treatment initiation
13) Approximately 24 months from treatment initiation
14) Up to 24 weeks from treatment initiation

1) Circa 12 mesi dall’inizio del trattamento
2) Circa 12 mesi dall’inizio del trattamento
3) Fino a 5 anni dall’inizio del trattamento
4) Fino a 5 anni dall’inizio del trattamento
5-10) Dalla prima dose fino a ed includendo 100 giorni dopo la dose
11) Circa 12 mesi dall’inizio del trattamento
12) Circa 12 mesi dall’inizio del trattamento
13) Circa 24 mesi dall’inizio del trattamento
14) Fino a 24 settimane dall’inizio del trattamento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity Assessments, Biomarker Assessments, Outcomes Research Assessments

Valutazioni di immunogenicità, valutazioni dei biomarker, risultati Valutazioni di ricerca

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Randomised:, open

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

United States

Austria

Denmark

France

Germany

Italy

Poland

Spain

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last follow-up visit of the last patient

Ultima Visita dell’ultimo paziente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

199

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

298

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

497

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS. See section 3.2 of the protocol for more details.

Alla conclusione dello studio, i soggetti che continuano ad avere un beneficio clinico saranno eleggibbili a ricevere il farmaco in studio fornito da BMS. Il farmaco verrà fornito tramite o un’ estensione dello studio o il rinnovo dello studio Il farmaco in studio che richiede l'approvazione da parte dell'autorità competente e dal comitato etico o tramite un altro meccanismo a discrezione del BMS. Vedere sezione 3.2 del protocollo per maggiori dettagli.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-18

P. End of Trial
P.	End of Trial Status	Trial now transitioned

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials