IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

March 31, 2020

Study Completion Date

May 31, 2021

Conditions
Adenocarcinoma Breast Stage IV
Interventions
BIOLOGICAL

IMP321 (eftilagimod alpha)

In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo

DRUG

Placebo

In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD

DRUG

Paclitaxel

Paclitaxel will be given in both treatment arms (classified as Non IMP)

Trial Locations (29)

1032

Szent Margit Kórház Onkológiai Osztály, Budapest

1062

MH Egészségügyi Központ Onkológiai Osztály, Budapest

1081

VU University Medical Center, Amsterdam

1200

Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique, Brussels

2570

AZ Sint-Maarten, Duffel

2610

GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research, Wilrijk

2650

Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit, Edegem

3000

UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven

3075

Erasmus MC, Rotterdam

5000

Clinique Sainte-Elisabeth, Namur

6162

Zuyderland MC, Geleen

6202

MUMC Medical Oncology department, Maastricht

8000

AZ Sint-Jan Burgge-Oostende, Bruges

9100

AZ Nikolass, Sint-Niklaas

9700

UMCG Medisch Centrum Groningen, Groningen

31059

Institut Claudius Regaud - IUC Toulouse - Oncopôle, Toulouse

42271

Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez

45136

KEM- Brustzentrum der Kliniken Essen-Mitte, Essen

60389

Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie, Frankfurt

69120

NCT - Nationales Centrum für Tumorerkrankungen, Heidelberg

72076

UFKT - Universitäts-Frauenklinik Tübingen, Tübingen

89081

UFU - Universitätsfrauenklinik Ulm, Ulm

92210

Institut Curie / Centre René Huguenin, Saint-Cloud

2262 BA

HMC Antoniushove, Leidschendam

5912 BL

VieCuri Medisch Centrum, Venlo

81 - 519

Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni, Gdynia

LS9 7TF

St James' Institute of Oncology, Leeds

M20 4BX

The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

All Listed Sponsors
lead

Immutep S.A.S.

INDUSTRY

NCT02614833 - IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma | Biotech Hunter | Biotech Hunter