Clinical trial NCT02614833: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma Breast Stage IV
Keywords: Hormone receptor positive
Lead sponsor: Immutep S.A.S.
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Able to give written informed consent and to comply with the protocol
2. Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
3. Female of age 18 years or above
4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel
5. 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.

Exclusion Criteria:

1. Prior chemotherapy for metastatic breast adenocarcinoma
2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
3. Inflammatory carcinoma
4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
5. 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
6. Symptomatic known cerebral and/or leptomeningeal metastases
7. Serious intercurrent infection
8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
9. Active acute or chronic infection
10. Active autoimmune disease requiring immunosuppressive therapy
11. Previous malignancies within the last three years other than breast carcinoma
12. Patients with prior organ or stem cell transplantation
13. Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.

Primary outcomes:
measure: Stage 1 to determine the recommended phase two dose for the randomised phase
timeFrame: Up to 12 months
measure: Assessment of Progression-Free Survival (PFS)
timeFrame: Up to 37 month
Secondary outcomes:
measure: Assessment of the safety and tolerability of IMP321 as compared to placebo
timeFrame: Up to 19 months
measure: Assessment of the overall survival (OS)
timeFrame: Up to 48 month
measure: Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax]
timeFrame: Up to 12 months
measure: Assessment of the change in quality of life (QOL)
timeFrame: Up to 37 months
measure: Evaluation of the time to next treatment
timeFrame: Up to 37 months
measure: Evaluation of objective response rate (ORR)
timeFrame: Up to 37 months
measure: Evaluation of stable disease
timeFrame: Up to 37 months
Other outcomes:
measure: Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage
timeFrame: Up to 37 months
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Burgge-Oostende
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique
city: Duffel
country: Belgium
facility: AZ Sint-Maarten
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit
city: Leuven
country: Belgium
facility: UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre
city: Namur
country: Belgium
facility: Clinique Sainte-Elisabeth
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolass
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Saint-Cloud
country: France
facility: Institut Curie / Centre René Huguenin
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud - IUC Toulouse - Oncopôle
city: Essen
country: Germany
facility: KEM- Brustzentrum der Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie
city: Heidelberg
country: Germany
facility: NCT - Nationales Centrum für Tumorerkrankungen
city: Tübingen
country: Germany
facility: UFKT - Universitäts-Frauenklinik Tübingen
city: Ulm
country: Germany
facility: UFU - Universitätsfrauenklinik Ulm
city: Budapest
country: Hungary
facility: Szent Margit Kórház Onkológiai Osztály
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ Onkológiai Osztály
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Geleen
country: Netherlands
facility: Zuyderland MC
city: Groningen
country: Netherlands
facility: UMCG Medisch Centrum Groningen
city: Leidschendam
country: Netherlands
facility: HMC Antoniushove
city: Maastricht
country: Netherlands
facility: MUMC Medical Oncology department
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Gdynia
country: Poland
facility: Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni
city: Leeds
country: United Kingdom
facility: St James' Institute of Oncology
state: West Yorkshire
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Immutep S.A.S.
name: Immutep S.A.S
role: STUDY_DIRECTOR
References: