Spots Global Cancer Trial Database for IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
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Trial Identification
Brief Title: IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
Official Title: AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel
Study ID: NCT02614833
Conditions
Study Description
Brief Summary: The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.
Detailed Description: This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages. Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel. Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
AZ Sint-Jan Burgge-Oostende, Brugge, , Belgium
Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique, Brussel, , Belgium
AZ Sint-Maarten, Duffel, , Belgium
Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit, Edegem, , Belgium
UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven, , Belgium
Clinique Sainte-Elisabeth, Namur, , Belgium
AZ Nikolass, Sint-Niklaas, , Belgium
GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research, Wilrijk, , Belgium
Institut de Cancérologie de la Loire, Saint Priest en Jarez, , France
Institut Curie / Centre René Huguenin, Saint-Cloud, , France
Institut Claudius Regaud - IUC Toulouse - Oncopôle, Toulouse Cedex 9, , France
KEM- Brustzentrum der Kliniken Essen-Mitte, Essen, , Germany
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie, Frankfurt, , Germany
NCT - Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
UFKT - Universitäts-Frauenklinik Tübingen, Tübingen, , Germany
UFU - Universitätsfrauenklinik Ulm, Ulm, , Germany
Szent Margit Kórház Onkológiai Osztály, Budapest, , Hungary
MH Egészségügyi Központ Onkológiai Osztály, Budapest, , Hungary
VU University Medical Center, Amsterdam, , Netherlands
Zuyderland MC, Geleen, , Netherlands
UMCG Medisch Centrum Groningen, Groningen, , Netherlands
HMC Antoniushove, Leidschendam, , Netherlands
MUMC Medical Oncology department, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
VieCuri Medisch Centrum, Venlo, , Netherlands
Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni, Gdynia, , Poland
St James' Institute of Oncology, Leeds, West Yorkshire, United Kingdom
The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
Name: Immutep S.A.S
Affiliation: Immutep S.A.S.
Role: STUDY_DIRECTOR
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