Clinical Trials Register

Summary
EudraCT Number:	2016-004603-31
Sponsor's Protocol Code Number:	PH1603
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-10-02
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

Spain - AEMPS

A.2

EudraCT number

2016-004603-31

A.3

Full title of the trial

A pilot trial of PEGPH20 (pegylatedhyaluronidase) in combination with avelumab (anti-PD-L1 MSB0010718C) in chemotherapy resistant pancreatic cancer

Estudio piloto de PEGPH20 (hialuronidasa pegilada) en combinación con Avelumab (anti-PD-L1 MSB0010718C) en carcinoma de páncreas (PDAC, del inglés: Pancreatic Ductal Adenocarcinoma) resistente a quimioterapia

A.3.1

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

A study using two medications, PEGPH20 (pegylatedhyaluronidase) and avelumab (anti-PD-L1 MSB0010718C), taken at the same time in patients with chemotherapy resistant pancreatic cancer

Estudio que utiliza dos medicamentos, PEGPH20 (pegylatedhyaluronidase) and avelumab(anti-PD-L1 MSB0010718C) tomados de manera simultánea por pacientes con cáncer de páncreas resistente a quimioteapia

A.4.1

Sponsor's protocol code number

PH1603

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	PH Research
B.1.3.4	Country	Spain
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	Halozyme, Inc
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Pfizer
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PH Research
B.5.2	Functional name of contact point	Clinical Trial Coordinator
B.5.3	Address:
B.5.3.1	Street Address	555 Fayetteville St, Ste 300
B.5.3.2	Town/ city	Raleigh
B.5.3.3	Post code	27601
B.5.3.4	Country	United States
B.5.6	E-mail	morgan@phresearchoncology.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1394
D.3 Description of the IMP
D.3.1	Product name	PEGylated Recombinant Human Hyaluronidase
D.3.2	Product code	PEGPH20
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	pegvorhyluronidase alfa
D.3.9.1	CAS number	1620390068
D.3.9.2	Current sponsor code	PEGPH20
D.3.9.3	Other descriptive name	PEGylated Recombinant Human Hyaluronidase
D.3.9.4	EV Substance Code	SUB33062
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	0.30
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	Avelumab
D.3.2	Product code	MSB0010718C
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	Avelumab
D.3.9.2	Current sponsor code	MSB0010718C
D.3.9.4	EV Substance Code	SUB176547
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	20
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.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

chemotherapy resistant advanced or locally advanced pancreatic ductal adenocarcinoma

Carcinoma ductal de páncreas avanzado o localmente avanzado resistente a quimioterapia

E.1.1.1

Medical condition in easily understood language

chemotherapy resistant advanced or locally advanced pancreatic cancer

Cáncer de páncreas avanzado o localmente avanzado resistente a quimioterapia

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	LLT
E.1.2	Classification code	10033604
E.1.2	Term	Pancreatic cancer
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

1. Determine objective response rate (ORR) per RECIST v1.1 criteria of this regimen
2. Assess the safety of this combination in patients with pancreatic ductal adenocarcinoma (PDAC)
3. Determine overall survival (OS), progression free survival (PFS), and CA19-9 tumor marker response

1. Determinar la Tasa Objetiva de Respuesta (ORR, del inglés: Objective Response Rate) de acuerdo a los criterios RECIST v1.1
2. Evaluar la seguridad de la combinación en pacientes con PDAC
3. Determinar la Supervivencia Global (OS, del inglés: Overall Survival), Supervivencia Libre de Progresión (PFS, del inglés: Progression Free Survival) y respuesta del marcador tumoral CA19-9

E.2.2

Secondary objectives of the trial

1. Determine immune ORR as per IR-RECIST v1.1
2. Determine effect of PEGPH20 in tumor hyaluronic acid content in plasma and paired tumor biopsies of patients with PDAC treated with this regimen
3. Determine effects of PEGPH20 in other tissue parameters including collagen content, cancer associated fibroblasts, and immune infiltrate
4. Determine the effect of PEGPH20 in tumor stiffness as measured by elastography

1. Determinar la ORR inmune, de acuerdo a los criterios IR-RECIST v1.1
2. Determinar el efecto de PEGPH20 en el contenido de ácido hialurónico (HA, del inglés: Hyaluronic Acid) del tumor en plasma y biopsias pareadas de tumor en pacientes con PDAC tratados con la combinación
3. Determinar los efectos de PEGH20 en otros parámetros tisulares incluido contenido de colágeno, fibroblastos asociados al tumor (CAF, del inglés: Cancer Associated Fibroblasts) e infiltrado inmune
4. Determinar el efecto de PEGPH20 en la rigidez del tumor, medido mediante elastografía

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form.
2. Histologically or cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC).
3. Accessible tumor for repeated tumor biopsies.
4. Progression to first line treatment for locally advanced or advanced disease. Prior adjuvant chemotherapy or chemoradiation therapy for early disease is allowed.
5. Male or female subjects age ≥18 years.
6. Radiologically measurable disease per RECIST v1.1.
7. Performance-status ECOG 0 or 2.
8. Life expectancy ≥ 3 months.
9. Resolved acute effects of any prior therapy to baseline or Grade ≤1 severity except for AEs not constituting a safety risk by investigator judgment.
10. Screening laboratory:
a. Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).
b. Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). .
c. Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula or serum creatinine ≤ 2.0 mg/dL.
d. Albumin ≥ 2.5 g/dL.
e. Coagulation: prothrombin time and international normalized ratio within normal limits (+/-15%). Partial thromboplastin time (PTT) within normal limits (+/-15%).
11. If a subject requires anticoagulation, treatment must be modified to enoxaparin.
12. Negative serum pregnancy test within 7 days before day 0 (first dose of study medication) if female subject is of childbearing potential.
13. Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for 30 days after the last dose of assigned treatment.
14. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, biopsies when required, and other procedures.

1. Firma del Consentimiento Informado aprobado por el CEIm (Comité Ético de Investigación Clínica)
2. PDAC confirmado mediante histolgía o citología
3. Existencia de metastasis accesibles que permitanrealizar dos biopsias
4. Haber progresado a la primera línea de tratamiento para enfermedad localmente avanzada o enfermedad avanzada. Está permitida la administración previa de quimioterapia adyuvante o quimio-radioterapia para enfermedad en estadio temprano.
5. Hombres o mujes de edad ≥ 18 años
6. Tumor medible radiológicamente de acuerdo a los criterios per RECIST v1.1.
7. Estado Funcional ECOG 0 -2.
8. Esperanza de vida ≥ 3 meses
9. Que todos los efectos adversos (AEs, del inglés: adverse events)agudos de tratamientos previos se hayan resuelto a nivel basal o por lo menos sean clasificados como grado ≤1 excepto aquellos AEs que no constituyan un riesgo de acuerdo al criterio del investigador
10. Parámetros de laboratorio:
a. Hematología: Recuento absoluto de neutrófilos (ANC, del inglés: Absolute neutrophil count) ≥ 1,5 × 109/L; recuento plaquetas ≥ 100 × 109/L, y hemoglobina≥ 9 g/dL (pueden haber sido transfundidos)
b. Hepáticos: Bilirrubina total ≤ 1,5 × Límite Superior de la Normalidad (UPN, del inglés: upper limit of normal) y niveles de AST y ALT levels ≤ 2,5 × ULN oniveles de AST y ALT ≤ 5 X ULN (en pacientes con enfermedad metastásica en hígado documentada)
c. Renal: Aclaramiento de creatinina ≥ 30 mL/min de acuerdo a la fórmula de Cockcroft-Gault formula o creatinina sérica ≤ 2,0 mg/dL.
d. Albúmina ≥ 2,5 g/dL.
e. Coagulación: Tiempo de protrombina y razón normalizada internacional en niveles normales (+/-15%). Tiempo parcial de tromboplastina (PTT, del inglés: Partial thromboplastin time) dentro de los niveles normales (+/-15%).
11. Si el paciente requiere estar anticuagulado, el tratamiento debe ser con enoxaparina.
12. Prueba de embarazo negativa durante los 7 días previos al día 0 (primera dosis de la medicación de estudio) en mujeres en edad reproductiva.
13. Tanto los pacientes varones como las mujeres en edad reproductiva y con riesgo de embarazo deben utilizar dos métodos efectivos de contracepción durante el estudio así como durante los 60 días posteriores a la administración de la última dosis de tratamiento. Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for 30 days after the last dose of assigned treatment.
14. Los pacientes deben estar dispuestos y cumplir con todas las visitas establecidas en el estudio, así como con los planes de tratamiento, los tests de laboratorio, las biopsias cuando sean necesarias, así como el resto de procedimientos necesarios.

E.4

Principal exclusion criteria

1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), prior history of CVA or history of TIA within 12 months or other known TE event present during the screening period.
2. Current use of megestrol acetate (use within 10 days of Day 1).
3. Contraindication to heparin as per institutional guidelines.
4. Women currently pregnant or breastfeeding.
5. Another primary cancer within the last 3 years currently requiring antineoplastic treatment with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
6. Current use of immunosuppressive medication within 2 weeks of study participation EXCEPT for the following: intranasal, inhaled, or topical steroids, or local steroid injection (e.g., intra-articular injection).
7. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent: Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
8. Prior organ transplantation including allogenic stem-cell transplantation.
9. Active infection requiring systemic therapy.
10. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
11. Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with testing per institutional guidelines.
12. Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
13. Known prior severe hypersensitivity to investigational product, hyaluronidase, or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
14. Any history of anaphylaxis or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
15. Clinically significant (i.e., active) cardiovascular disease:, myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
16. Prior cerebrovascular accident/stroke.
17. Clinically significant carotid artery disease (e.g prior carotid surgery, symptomatic and/or requires treatment)
18. Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator’s judgment are acceptable.
19. Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
20. Inability to comply with study and follow-up procedures as judged by the Investigator.
21. Known alcohol or drug abuse.
22. All subjects with brain metastases, except those meeting the following criteria:
• Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
• No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
• Subjects must not be receiving any treatment for the brain metastases (e.g. steroids, anticonvulsants) for at least 2 weeks prior to enrollment.

1. Evidencia clínica de Trombosis Venosa Profunda (DVT, del inglés: deep vein thrombosis (DVT); embolismo pulmonary (PE, del inglés: pulmonary embolism); historia previa de accidente cerebrovascular (CVA, del inglés: cerebrovascular accident) o ictus (TIA, del inglés: transient ischemic attack) durante los 12 meses previos a la inclusión en el estudio, o cualquier otro episodio tromboembólico presente durante el periodo de screening.
2. Uso de acetato de megestrol (administración previa durante los 10 días previos al Día 1)
3. Uso contraindicado de heparina, de acuerdo a las Guías Locales.
4. Mujeres embarazadas o en período de lactancia
5. Haber presentado otro tumor primario durante los 3 años previos al inicio del estudio que hubiera requerido la administración de antineoplásicos con la excepción de carcinoma de piel no melanoma, cáncer de próstata en estadios iniciales o carcinoma in situ (tratado con éxito)
6. Administración de fármacos inmunosupresores (durante las dos semanas previas al inicio del estudio) EXCEPTO: a) administración de corticoids for vía intranasal, inhalados, vía tópica, o inyección local (p. ej. Inyección intraarticular); b) corticoides sistémicos a dosis fisiológicas ≤ 10 mg/día de prednisona o equivalente; c) administración de esteroides como premedicación para prevenir reacciones de hipersensibildad (p. ej. Premedicación previa a la realización de un escáner)
7. Enfermedad autoinmune activa que pudiera deteriorar si se administra un fármaco inmunoestimulador. Pacientes con Diabetes Mellitus tipo 1, vitíligo, psoriasis, hipo o hipertiroidismo que no requieren la administración de tratamiento inmunosupresor son elegibles para participar en el estudio.
8. Trasplante de órgano previo, incluido trasplante alogénico de células madre
9. Infección activa que requiera tratamiento sistémico
10. Test positivo para HIV o síndrome de inmunodeficiencia adquirida.
11. Hepatitis B o Hepatitis C activa, siguiendo los protocolos de los hospitalesparticipantes..
12. Está prohibida la administración de vacunas durante las 4 semanas previas a la administración de la primera dosis de avelumab así como a lo largo del estudio, excepto para las vacunas inactivadas
13. Hipersensibilidad grave conocida tanto al fármaco en investigación, como a la hialuronidasa o cualquier componente de la formulación, incluidas las reacciones de hipersensibilidad graves a anticuerpos monoclonales (Grado ≥ 3 NCI CTCAE v 4.03)
14. Historia previa de anafilaxia o episodios de asma no controlada (esto es, 3 o más de los criterios de asma parcialmente controlada)
15. Enfermedad cardiovascular clínicamente significativa (p.ej. active): Infarto miocardio (durante < 6 meses al inicio del estudio); angina inestable; insuficiencia cardíaca congestive (≥ New York Heart Association Classification Class II), o arritmia cardíaca grave que requiere medicación
16. Accidente cerebrovascular previo
17. Afectación de la arteria carótida clínicamente significativa (p. ej. Cirugía previa arteria carótida, enfermedad sintomática o que requiera tratamiento)
18. Toxicidad persistente de tratamientos previos (Grado > 1 NCI CTCAE v. 4.03); sin embargo se permite alopecia, neuropatía sensorial (Grado ≤ 2) u otras toxicidades ≤ 2 que no constituyan riesgo de acuerdo al criterio del investigador
19. Otras enfermedades agudas o crónicas incluyendo colitis inmune, enfermedad inflamatoria intestinal, neumonitis inmune, fibrosis pulmonar o enfermedades psiquiátricas incluyendo ideas o comportamientos suicidas recientes (durante el año previo); alteraciones analíticas que puedan aumentar el riesgo asociado a la participación en el estudio o que puedan interferir con la interpretación de los resultados del estudio , y que, a juicio del investigador, haga que el candidato no sea adecuado para participar en el estudio.
20. Incapacidad por parte del paciente de cumplir con las exigencias del estudio así como con los procedimientos durante el periodo de seguimiento, a criterio del investigador. Inability to comply with study and follow-up procedures as judged by the Investigator.
21. Abuso de alcohol o drogas conocido
22. Todos los pacientes con metástasis cerebrales, excepto aquellos que cumplen los siguientes criterios:
• Metástasis cerebrales tratadas con tratamientos locales y están clínicamente estables durante las dos semanas previas a la inclusión en el estudio
• Ausencia de síntomas neurológicos relacionados con la localización cerebral de la enfermedad (se aceptan las secuelas que son consecuencia del tratamiento de las metástasis cerebrales)
• Los sujetos no pueden estar recibiendo ningún tratamiento para las metástasis cerebrales (p. ej. Esteroides, anticonvulsivantes) durante al menos las 2 semanas previas a la inclusion en el estudio

E.5 End points

E.5.1

Primary end point(s)

1. To determine the objective response rate (ORR) as per RECIST v1.1 criteria of this regimen.
2. To assess the safety of this combination in patients with PDAC.
3. To determine the overall survival (OS), progression free survival (PFS) and CA19-9 tumor marker response.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Every 8 weeks via CT or MRI
2. Monthly
3. Monthly

1. Cada 8 semanas via TAC / resonancia magnética
2. Mensualmente
3. Mensualmente

E.5.2

Secondary end point(s)

1. To determine the immune ORR as per IR-RECIST v1.1
2. To determine the effect of PEGPH20 in tumor hyaluronic acid (HA) content in plasma and paired tumor biopsies of patients with PDAC treated with this regimen.
3. To determine the effects of PEGPH20 in other tissue parameters including collagen content, cancer associated fibroblasts (CAF), and immune infiltrate.
4. To determine the effect of PEGPH20 in tumor stiffness as measured by elastography.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Every 8 weeks via CT or MRI
2. Cycle 1 Days 1,4,8,11,15
3. Cycle 1, Day 15
4. Cycle 1, between Day 2 - Day 15

1. Cada 8 semanas via TAC / resonancia magnética
2. Ciclo 1, días 1, 4, 8, 11, 15
3. Ciclo 1, día 15
4. Ciclo 1, entre los días 2 y 15

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

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

E.8.1.1

Randomised

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

LVLS (UPUV)

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

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

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.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 treatment, the subject will be entered into long-term follow up during which information on the subject’s survival status and subsequent anti-cancer therapy will be obtained by the site every month. Long-term follow-up will continue until the subject dies, is lost to follow-up, or withdraws consent. Safety follow up will be performed up to 90 days after the last dose of avelumab.

Al final del tratamiento, el paciente entrará en un periodo de seguimiento a largo plazo durante el que información sobre su estado, supervivencia y posterior terapia anti-cancerígena será obtenida por el centro mensualmente. Seguimiento a largo plazo continuará hasta que el paciente fallezca, permanezca ilocalizable o retire su consentimiento. Seguimiento de seguridad se realizará 90 días tras la última dosis de avelumab.

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

2017-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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