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

NCT02614833 | Completed Phase 2 DMC

• 1 other identifier: IMP321 P011
• Study Type: interventional
• Target: 242
• Locations: 7 countries
• Sites: 29

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.

Conditions

Adenocarcinoma Breast Stage IV

Keywords

Hormone receptor positive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• Assessment of the change in quality of life (QOL)

  Up to 37 months

• Evaluation of the time to next treatment

  Up to 37 months

Other Outcomes (1)

• Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage

  Up to 37 months

Study Arms (2)

Paclitaxel + IMP321 at the RPTD

EXPERIMENTAL

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

Biological: IMP321 (eftilagimod alpha); Drug: Paclitaxel

Comparator: Paclitaxel + Placebo

ACTIVE COMPARATOR

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

Drug: Placebo; Drug: Paclitaxel

Interventions

IMP321 (eftilagimod alpha) BIOLOGICAL

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

Paclitaxel + IMP321 at the RPTD

Placebo DRUG

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

Comparator: Paclitaxel + Placebo

Paclitaxel DRUG

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

Comparator: Paclitaxel + Placebo; Paclitaxel + IMP321 at the RPTD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immutep S.A.S.: lead

Study Sites (29)

AZ Sint-Jan Burgge-Oostende

Bruges, 8000, Belgium

Location

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

Brussels, 1200, Belgium

Location

AZ Sint-Maarten

Duffel, 2570, Belgium

Location

Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit

Edegem, 2650, Belgium

Location

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

Leuven, 3000, Belgium

Location

Clinique Sainte-Elisabeth

Namur, 5000, Belgium

Location

AZ Nikolass

Sint-Niklaas, 9100, Belgium

Location

GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research

Wilrijk, 2610, Belgium

Location

Institut Curie / Centre René Huguenin

Saint-Cloud, 92210, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

Institut Claudius Regaud - IUC Toulouse - Oncopôle

Toulouse, 31059, France

Location

KEM- Brustzentrum der Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie

Frankfurt, 60389, Germany

Location

NCT - Nationales Centrum für Tumorerkrankungen

Heidelberg, 69120, Germany

Location

UFKT - Universitäts-Frauenklinik Tübingen

Tübingen, 72076, Germany

Location

UFU - Universitätsfrauenklinik Ulm

Ulm, 89081, Germany

Location

Szent Margit Kórház Onkológiai Osztály

Budapest, 1032, Hungary

Location

MH Egészségügyi Központ Onkológiai Osztály

Budapest, 1062, Hungary

Location

VU University Medical Center

Amsterdam, 1081, Netherlands

Location

Zuyderland MC

Geleen, 6162, Netherlands

Location

UMCG Medisch Centrum Groningen

Groningen, 9700, Netherlands

Location

HMC Antoniushove

Leidschendam, 2262 BA, Netherlands

Location

MUMC Medical Oncology department

Maastricht, 6202, Netherlands

Location

Erasmus MC

Rotterdam, 3075, Netherlands

Location

VieCuri Medisch Centrum

Venlo, 5912 BL, Netherlands

Location

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

Gdynia, 81 - 519, Poland

Location

St James' Institute of Oncology

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology

Manchester, M20 4BX, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Interventions

soluble LAG-3 protein, human; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Immutep S.A.S

  Immutep S.A.S.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 25, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

HU (2); GB (3); FR (3); NL (7); BE (8); PL (1); DE (5)