IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
- Conditions
- Adenocarcinoma Breast Stage IV
- Interventions
- Registration Number
- NCT02614833
- Lead Sponsor
- Immutep S.A.S.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 242
- Able to give written informed consent and to comply with the protocol
- Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
- Female of age 18 years or above
- Patients who are indicated to received first line chemotherapy with weekly paclitaxel
- Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1
6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
- Prior chemotherapy for metastatic breast adenocarcinoma
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
- Inflammatory carcinoma
- Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
- Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
- Symptomatic known cerebral and/or leptomeningeal metastases
- Serious intercurrent infection
- Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
- Active acute or chronic infection
- Active autoimmune disease requiring immunosuppressive therapy
- Previous malignancies within the last three years other than breast carcinoma
- Patients with prior organ or stem cell transplantation
- Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel + IMP321 at the RPTD IMP321 (eftilagimod alpha) The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections Comparator: Paclitaxel + Placebo Placebo The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections Paclitaxel + IMP321 at the RPTD Paclitaxel The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections Comparator: Paclitaxel + Placebo Paclitaxel The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
- Primary Outcome Measures
Name Time Method Stage 1 to determine the recommended phase two dose for the randomised phase Up to 12 months Assessment of Progression-Free Survival (PFS) Up to 37 month
- Secondary Outcome Measures
Name Time Method Evaluation of objective response rate (ORR) Up to 37 months Evaluation of stable disease Up to 37 months Assessment of the change in quality of life (QOL) Up to 37 months Evaluation of the time to next treatment Up to 37 months Assessment of the safety and tolerability of IMP321 as compared to placebo Up to 19 months Assessment of the overall survival (OS) Up to 48 month Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax] Up to 12 months
Trial Locations
- Locations (29)
UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre
🇧🇪Leuven, Belgium
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie
🇩🇪Frankfurt, Germany
Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit
🇧🇪Edegem, Belgium
KEM- Brustzentrum der Kliniken Essen-Mitte
🇩🇪Essen, Germany
NCT - Nationales Centrum für Tumorerkrankungen
🇩🇪Heidelberg, Germany
HMC Antoniushove
🇳🇱Leidschendam, Netherlands
MUMC Medical Oncology department
🇳🇱Maastricht, Netherlands
VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
AZ Sint-Jan Burgge-Oostende
🇧🇪Brugge, Belgium
Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique
🇧🇪Brussel, Belgium
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Szent Margit Kórház Onkológiai Osztály
ðŸ‡ðŸ‡ºBudapest, Hungary
AZ Sint-Maarten
🇧🇪Duffel, Belgium
Clinique Sainte-Elisabeth
🇧🇪Namur, Belgium
MH Egészségügyi Központ Onkológiai Osztály
ðŸ‡ðŸ‡ºBudapest, Hungary
Zuyderland MC
🇳🇱Geleen, Netherlands
UMCG Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Institut Claudius Regaud - IUC Toulouse - Oncopôle
🇫🇷Toulouse Cedex 9, France
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
UFKT - Universitäts-Frauenklinik Tübingen
🇩🇪Tübingen, Germany
UFU - Universitätsfrauenklinik Ulm
🇩🇪Ulm, Germany
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
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