Clinical Trials Register

Summary
EudraCT Number:	2021-004807-42
Sponsor's Protocol Code Number:	CA116001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-10-19
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-004807-42

A.3

Full title of the trial

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, versus Investigator’s Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Estudio en fase II abierto y aleatorizado de farletuzumab ecteribulina (MORAb-202), un conjugado de anticuerpo y fármaco dirigido al receptor de folato alfa frente a la quimioterapia elegida por el investigador en mujeres con cáncer seroso de alto grado (SAG) resistente al platino, de ovario peritoneal primario o de trompas de Falopio.

A.3.1

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

A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Estudio en fase II de MORAb-202 en el cáncer seroso de alto grado resistente al platino, de ovario peritoneal primario o de trompas de Falopio

A.4.1

Sponsor's protocol code number

CA116001

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1269-0669

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 Belgium
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	Head of the GSM-CT
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.5.6	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	MORAb-202
D.3.2	Product code	BMS-986445
D.3.4	Pharmaceutical form	Lyophilisate 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	Farletuzumab ecteribulin
D.3.9.2	Current sponsor code	BMS-986445
D.3.9.4	EV Substance Code	SUB215766
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	MORAb-202
D.3.2	Product code	BMS-986445
D.3.4	Pharmaceutical form	Lyophilisate 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	Farletuzumab ecteribulin
D.3.9.2	Current sponsor code	BMS-986445
D.3.9.4	EV Substance Code	SUB215766
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	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	Paclitaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Bendalis GmbH
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	Paclitaxel
D.3.2	Product code	L01C D01
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	Paclitaxel
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	6
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 4
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	Pegylated Liposomal Doxorubicin
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Holding B.V.
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	Pegylated Liposomal Doxorubicin
D.3.2	Product code	L01DB01
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	doxorubicin
D.3.9.1	CAS number	C50664300
D.3.9.3	Other descriptive name	DOXORUBICIN, LIPOSOMAL, PEGYLATED
D.3.9.4	EV Substance Code	SUB33393
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	2
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 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	topotecan
D.2.1.1.2	Name of the Marketing Authorisation holder	medac
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.3.4	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	Topotecan
D.3.9.1	CAS number	123948-87-8
D.3.9.4	EV Substance Code	SUB11191MIG
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	1
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 6
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	topotecan
D.2.1.1.2	Name of the Marketing Authorisation holder	medac
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.3.4	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	Topotecan
D.3.9.1	CAS number	123948-87-8
D.3.9.4	EV Substance Code	SUB11191MIG
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	1
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Cáncer seroso de alto grado resistente al platino, de ovario peritoneal primario o de trompas de Falopio

E.1.1.1

Medical condition in easily understood language

Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Cáncer de ovario, peritoneal primario o de trompas de Falopio

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10033128
E.1.2	Term	Ovarian cancer
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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10016180
E.1.2	Term	Fallopian tube cancer
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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10052171
E.1.2	Term	Peritoneal carcinoma
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

1. To compare objective response rate of MORAb-202 vs Investigator’s Choice (IC) chemotherapy (in all randomized participants)
2. To evaluate the proportion of participants with treatment-related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated participants

1. Comparar la tasa de respuesta objetiva (TRO) de MORAb-202 frente a la quimioterapia EI (en todas las participantes aleatorizadas).
2. Evaluar la proporción de participantes con acontecimientos adversos relacionados con el tratamiento (AART) que provoquen la interrupción en cada grupo en los 6 meses posteriores a la administración de la primera dosis del fármaco del estudio en todas las participantes tratadas.

E.2.2

Secondary objectives of the trial

1. To evaluate Disease Control Rate (DCR) of MORAb-202 and IC chemotherapy in all randomized participants
2. To evaluate Duration of Response (DoR) of MORAb-202 and IC chemotherapy in all randomized participants
3. To evaluate Progression-Free Survival (PFS) of MORAb-202 and IC chemotherapy in all randomized participants

1. Evaluar la seguridad y la tolerabilidad de MORAb-202 y la quimioterapia EI en todas las participantes tratadas.
2. Evaluar la tasa de control de la enfermedad (TCE) de MORAb-202 y la quimioterapia EI en todas las participantes aleatorizadas.
3. Evaluar la duración de la respuesta (DR) de MORAb-202 y la quimioterapia EI en todas las participantes aleatorizadas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Participants must be 18 years old or local age of majority at the time of signing the informed consent
2) Female participants with histologically confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
3) Platinum-resistant disease, defined as:
- For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles.
- For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
4) Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
- Participants must have received prior treatment with bevacizumab or must be deemed medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
NOTES:
Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy.
Therapy changed in the absence of progression will be considered part of the same line.
5) Disease progression per RECIST v1.1 (by Investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
6) Either formalin-fixed, paraffin-embedded (FFPE) tissue or newly-obtained biopsies must be available for FRα assessment prior to randomization.
7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Participantes de sexo femenino con diagnóstico confirmado histológicamente de cáncer de ovario, peritoneal primario o de trompas de Falopio SAG.
Enfermedad resistente al platino, definida como:
-Para las participantes que solo recibieron 1 línea de tratamiento con platino: progresión entre >1 mes y ≤6 meses después de la última dosis de tratamiento con platino de al menos 4 ciclos.
Para las participantes que solo recibieron 2 o 3 líneas de tratamiento con platino:
progresión ≤6 meses después de la última dosis de tratamiento con platino.
Las participantes han recibido al menos 1 pero no más de 3 líneas previas de tratamiento sistémico y para quienes el tratamiento en monoterapia es adecuado como siguiente línea de tratamiento. Las participantes pueden haber sido tratadas con hasta 1 línea de tratamiento después de la determinación de la resistencia al platino.
Las participantes deben haber recibido tratamiento previo con bevacizumab o haber sido médicamente inapropiadas o no aptas/intolerantes para recibir bevacizumab, haberse negado a recibir bevacizumab o no poder recibir bevacizumab debido a la falta de acceso.

NOTAS:
La quimioterapia prequirúrgica ± adyuvante se considerará 1 línea de tratamiento.
El tratamiento de mantenimiento (p. ej., bevacizumab, inhibidores de la poli [adenosín difosfato-ribosa] polimerasa [PARP]) se considerará parte de la línea de tratamiento precedente.
El tratamiento modificado en ausencia de progresión se considerará parte de la misma línea.

Progresión de la enfermedad según los criterios RECIST v1.1 (según la evaluación del investigador) de al menos 1 lesión medible durante o después del tratamiento más reciente.
Antes de la aleatorización debe disponerse de tejido fijado en formol e incluido en parafina (hasta 5 años de antigüedad) o de biopsias recién obtenidas para la evaluación de FRα. La muestra tumoral (bloque de tejido [preferible] o un mínimo de 15 cortes sin teñir) debe ser evaluable para el análisis de IHQ del FRα para cumplir los criterios de aptitud. Se permitirá la repetición del envío de muestras a las participantes con FRα por IHQ no evaluable que, por lo demás, sean aptas.

Estado funcional de 0 o 1 según el Grupo Oncológico Cooperativo de la Costa Este de Estados Unidos.
La participante debe tener ≥18 años (o la edad legal para dar el consentimiento en la jurisdicción en la que se realiza el estudio) en el momento de firmar el formulario de consentimiento informado.

E.4

Principal exclusion criteria

Main Exclusion Criteria:
- Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer
- Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
- Pulmonary function test (PFT) abnormalities
- Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
- Recent chest radiotherapy received under 6 months before starting study treatment
- Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement
- Uncontrolled or significant cardiovascular conditions within 6 months prior
- Uncontrolled medical disorders that, in the opinion of the Investigator or Sponsor, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results
- Prior treatment with an investigational FRα-targeting agent and FRα-targeting ADC

- Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- Inadequate liver function evidenced by abnormal levels of total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or serum albumin

- Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients
- History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C
- Participants currently in other interventional trials may not participate in BMS clinical trials until the protocol specific washout period is achieved

-Histología de células claras, de histología mucinosa, endometrioide o sarcomatosa, o tumores mixtos que contengan componentes de alguna de estas histologías, o cáncer de ovario de bajo grado o límite.
-Cáncer de ovario primario resistente al platino, definido como progresión de la enfermedad en el mes posterior a la última dosis del tratamiento de primera línea con platino.
-Anomalías en la prueba de la función pulmonar: FEV1 <70 % o CVF <60 % y DLCO <80 %.
-EPI/neumonitis actual evaluada por el investigador, o sospecha de EPI/neumonitis en la selección o antecedentes de EPI/neumonitis de cualquier
intensidad, incluidas las EPI/neumonitis por un tratamiento antineoplásico previo.
-Neumonía infecciosa actual, antecedentes de neumonía vírica (incluida la infección relacionada con la enfermedad del coronavirus de 2019 [COVID-19]) con indicios de anomalías radiológicas persistentes.
-Retención significativa de líquidos en el tercer espacio (p. ej., ascitis o derrame pleural) que requiere drenaje repetido.
-Derrame pericárdico de importancia clínica que requiere drenaje.
Neumonectomía previa. Se permiten la lobectomía y la segmentectomía previas >12 meses antes del tratamiento.
Radioterapia torácica reciente. Se pueden permitir participantes con radiación en el pecho o la pared torácica (p.ej., antecedentes de cáncer de mama) si la radiación torácica se documenta >6 meses antes de iniciar el tratamiento del estudio.
-Cualquier trastorno autoinmunitario, del tejido conectivo o inflamatorio (p. ej., artritis reumatoide, síndrome de Sjögren, sarcoidosis, etc.) en el que se documente (o se sospeche) afectación pulmonar.
-Compresión de la médula espinal o metástasis sintomáticas del sistema nervioso central (SNC) no tratadas. Las participantes son aptas si las metástasis en el SNC son asintomáticas y no requieren tratamiento inmediato, o se han tratado, y si las participantes han retornado neurológicamente a los valores iniciales (excepto signos o síntomas residuales relacionados con el tratamiento del SNC). Además, las participantes deben haber interrumpido el tratamiento con anticonvulsivos y deben haber interrumpido los corticoesteroides o estar recibiendo una dosis estable o descendente de ≤10 mg al día de prednisona (o equivalente)

E.5 End points

E.5.1

Primary end point(s)

1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment
2. Occurence of TRAEs leading to discontinuation.

1. TRO según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), v1.1, y la evaluación del investigador.
2. AART que provoquen la interrupción.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Up to 2 years
2. Up to 2 years

1. Hasta 2 años
2. Hasta 2 años

E.5.2

Secondary end point(s)

1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities
2. DoR by RECIST v1.1 per investigator Assessment among responders
3. PFS by RECIST v1.1 per Investigator Assessment
4. DCR by RECIST v1.1 per Investigator Assessment

-Incidencia e intensidad de acontecimientos adversos (AA)/acontecimientos adversos graves (AAG), AA relacionados con el tratamiento, AAG que motivaron la interrupción, AA de especial interés (AAEI), muertes y anomalías analíticas.
-TCE según los criterios RECIST v1.1 y la evaluación del investigador.
-DR según los criterios RECIST v1.1 y la evaluación del investigador

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Up to 2 years
2. Up to 2 years
3. Up to 2 years
4. Up to 2 years

1. Hasta 2 años
2. Hasta 2 años
3. Hasta 2 años
4. Hasta 2 años

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

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

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

Yes

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)

Yes

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

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

Chile

Israel

Japan

Korea, Republic of

United States

France

Spain

Italy

Belgium

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

End of study is defined as the last participant’s last visit.

El final del estudio se define como la última visita del último participante.

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

F.4.2.2

In the whole clinical trial

150

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)

Continuous safety and tumor assessment evaluation will guide the decision to treat a participant with additional cycles of study therapy beyond 2 years, if the participant has a confirmed clinical benefit.

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

2023-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-11-14

P. End of Trial
P.	End of Trial Status	Ongoing

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Orphan Designation Number:
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