Clinical Trials Register

Summary
EudraCT Number:	2015-004816-39
Sponsor's Protocol Code Number:	CA012-004
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-04
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-004816-39

A.3

Full title of the trial

A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination
with Nivolumab or Ipilimumab in Subjects with Advanced Solid Tumors

Uno Studio di Fase 1/2a di BMS-986178 somministrato in mono terapia o in combinazione con Nivolumab o con Ipilimumab in soggetti con tumori solidi avanzati

A.3.1

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

Study of BMS-986178 Monotherapy or in Combination With Nivolumab
and/or Ipilimumab in Subjects With Advanced Solid Tumors.

Studio di BMS-986178 in Monoterapia o in Combinazione con Nivolumab e/o Ipilimumab in Soggetti con tumori solidi avanzati.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CA012-004

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02737475

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1175-8335

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	000
B.5.5	Fax number	000
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	NA
D.3.2	Product code	BMS-986178
D.3.4	Pharmaceutical form	Solution for injection
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.3.9.2	Current sponsor code	BMS-986178
D.3.9.3	Other descriptive name	BMS986178
D.3.9.4	EV Substance Code	SUB181367
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	25
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	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
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.3.4	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-936558-01
D.3.9.3	Other descriptive name	BMS-936558, MDX1106, ONO-4538
D.3.9.4	EV Substance Code	SUB122750
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: 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	YERVOY
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.3.4	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	00323000
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	BMS-734016
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: 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	TRIAXIS - 1 DOSE DA 0.5 ML SOSPENSIONE INIETTABILE 1 FLACONCINO IN VETRO DA UNA DOSE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR MSD S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DIPHTHERIA, TETANUS, PERTUSSIS vaccine
D.3.9.2	Current sponsor code	Tdap
D.3.9.3	Other descriptive name	DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
D.3.9.4	EV Substance Code	SUB180576
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0
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)	Yes
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

Advanced Solid Tumors

Tumori Solidi Avanzati

E.1.1.1

Medical condition in easily understood language

Advanced Solid Tumors

Tumori Solidi Avanzati

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	LLT
E.1.2	Classification code	10065252
E.1.2	Term	Solid tumor
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the safety, tolerability, dose-limiting toxicities (DLTs), and
maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of
BMS-986178 administered alone or in combination with nivolumab
and/or ipilimumab in subjects with advanced solid tumors.

Determinare la sicurezza, tollerabilità, tossicità limitante la dose (DLTs), massima dose tollerata (MTD)/dose raccomandata per la Fase 2 di BMS-986178 somministrato da solo o in combinazione con nivolumab e/o ipilimumab in soggetti con tumori solidi avanzati

E.2.2

Secondary objectives of the trial

To investigate the preliminary anti-tumor activity of BMS-986178
administered alone or in combination with nivolumab and/or ipilimumab
in subjects with advanced solid tumors; To characterize the
pharmacokinetics (PK) of BMS-986178 administered alone or in
combination with nivolumab and/or ipilimumab; To characterize the
immunogenicity of BMS-986178 administered alone or in combination
with nivolumab and/or ipilimumab and the immunogenicity of nivolumab
or ipilimumab administered with BMS-
986178.
To assess the proportion of subjects showing a change in
pharmacodynamic biomarkers of BMS-986178 administered in
combination with nivolumab or nivolumab monotherapy (Part 8).

Investigare la preliminare attività anti-tumorale di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab in soggeti con tumori solidi avanzati. Caratterizzare la farmacocinetica (PK) di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab.
Caratterizzare la immunogenicità di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab, e la immunogenicità di nivolumab o ipilimumab somministrato con BMS-986178
Determinare la proporzione di soggetti che mostrano cambiamenti nella farmacodinamica di biomarcatori di BMS-986178 somminstrato in combinazione con nivolumab o nivolumab in monoterapia (Parte 8)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects must be refractory to or intolerant of established therapy known to provide clinical benefit for their condition, i.e., subjects must not be candidates for regimens known to provide clinical benefit
• ECOG (Eastern Cooperative Oncology Group) 0-1
• Men and women 18 years old or older
• At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1

• I soggetti devono essere refrattari o intolleranti a terapie stabilite note per provvedere beneficio clinico alla loro condizione, ovvero i soggetti non devono essere candidati a regimi noti per provvedere beneficio clinico
• ECOG 0-1
• Soggetti maggiorenni (maschili e femminili)
• Almeno una lesione misurabile alla baseline mediante CT (tomografia computerizzata) o MRI (risonanza magnetica) come da RECIST v. 1.1

E.4

Principal exclusion criteria

• Known central nervous system metastases or central nervous system as the only source of disease
• Concomitant malignancies
• Active known or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• Major surgery less than 4 weeks before the start of the study

• Metastasi note al sistema nervoso centrale o sistema nervoso centrale come unica sede di malattia
• Neoplasie concomitanti
• Nota attiva o sospetta malattia autoimmune
• Malattia cardiovascolare non controllata o significativa
• Chirurgia importante entro 4 settimane prima dell’inizio dello Studio

E.5 End points

E.5.1

Primary end point(s)

Incidence of AE's (adverse events) and SAE's (serious adverse events),
AE's leading to discontinuation, deaths and clinical laboratory test abnormalities

primario Incidenza di Eventi Avversi (AEs) e Eventi Avversi Seri (SAEs), AE che portano a discontinuazione, morte e anormalità in risultati di test di di laboratorio

E.5.1.1

Timepoint(s) of evaluation of this end point

Over 4 years

Oltre 4 anni

E.5.2

Secondary end point(s)

• Cmax (maximum observed serum concentration) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Tmax (time of maximum observed concentration) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Ctau (the observed concentration at the end of a dosing interval) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • CLT (total body clearance) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC (TAU), Cmax and Ctau)] for BMS- 986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Ctrough [trough observed plasma concentrations (this includes predose concentrations (C0) and Ctau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Immunoassay of anti-nivolumab antibody in combination with anti- BMS-986178 antibody • Immunoassay of anti-ipilimumab antibody in combination with anti- BMS-986178 antibody • Objective Response Rate (ORR) • Progression Free Survival Rate (PFSR) • Immunoassay of anti-BMS-986178 antibody alone

End point secondario - Cmax (concentrazione di siero massima osservata) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Tmax (tempo di concentrazione massima osservata) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AUC (0-t) (area sotto la curva tempo-concentrazione idal tempo 0 al tempo t) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AUC (TAU) ((area sotto la curva tempo-concentrazione in 1 intervallo di dose) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Ctau (la concentrazione osservata alla fine di un intervallo di dose) BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - CLT (clearance corporea totale) BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Css-avg [concentrazione media oltre l’intervallo di dose (AUC(TAU)/tau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AI [rapporto di una misura di esposizione allo stato stazionario rispetto a quella dopo la prima dose (misura di esposizione include AUC (TAU), Cmax e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - T-HALFeff [emività di eliminazione effettiva per spiegare il grado di accumulazione per una specifica misura di esposizione (misura di esposizione include AUC(TAU), Cmax e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Ctrough [concentrazioni osservate mediante plasma (include concentrazioni predose (C0) e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Immunoassay di anticorpi anti-nivolumab in combinazione con anticorpi anti-BMS-986178 - immunoassay di anticorpi anti-ipilimumab in combinazione con anticorpi anti-BMS-986178 - Tasso di Risposta Obiettivo (ORR) - Tasso di Sopravvivenza Libera da Malattia (PFSS) - Immunoassay di anticorpi anti-BMS986178 da solo

E.5.2.1

Timepoint(s) of evaluation of this end point

• Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Css-avg; AI; T-HALFeff; Ctrough; Immunoassay of anti-nivolumab antibody in combination with anti-BMS-986178 antibody; Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody : Approximately 100 days after the final study drug administration (end of treatment) • ORR; PFSR: Approximately 2 years • Immunoassay of anti-BMS-986178 antibody alone: Approximately 100 days after 6 months of treatment

Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Css-avg; AI; T-HALFeff; Ctrough; Immunoassay di anticorpi anti-nivolumab in combinazione con anticorpi anti-BMS-986178; Immunoassay di anticorpi anti-ipilimumab in combinazione con anticorpi anti-BMS-986178: approssimativamente 100 giorni sopo l’ultima somministrazione di farmaco sperimentale (fine del trattamento) • ORR; PFSR: approssimativamente 2 anni • Immunoassay di anticorpi anti-BMS986178 da solo: approssimativamente 100 giorni dopo 6 mesi di 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

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: The secondary objective of immunogenicity will be assessed by the frequency of positive ADA to BMS-986178 or nivolumab or ipilimumab.

Immunogenicitià: l'obiettivo secondario di immunogenicitià sarà determinato dalla frequeza di ADA positivi a BMS986178 o nivolumab o ipilimumab

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

E.8.1.2

Open

Yes

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

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

Canada

Israel

United States

France

Italy

Netherlands

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

LPLV

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:

247

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

357

F.2 Gender

F.2.1

Female

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

107

F.4.2.2

In the whole clinical trial

604

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 end of the study, BMS will not continue to provide BMS-supplied study drug to subjects and investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.

Alla fine dello Studio, BMS non continuerà a fornire famarci sperimenatli BMS a soggetti e investigatori a meno che BMS decida di estendere lo Studio. L'Investigatore dovrà assicurarsi che il soggetto riceva l'appropriato trattamento in base agli standard of care per la condizione in studio.

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

2017-05-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-23

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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