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

October 4, 2021 updated by: Immutep S.A.S.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Burgge-Oostende
      • Brussel, Belgium, 1200
        • Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique
      • Duffel, Belgium, 2570
        • AZ Sint-Maarten
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit
      • Leuven, Belgium, 3000
        • UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre
      • Namur, Belgium, 5000
        • Clinique Sainte-Elisabeth
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolass
      • Wilrijk, Belgium, 2610
        • GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research
  • France
      • Saint Priest en Jarez, France, 42271
        • Institut de Cancérologie de la Loire
      • Saint-Cloud, France, 92210
        • Institut Curie / Centre René Huguenin
      • Toulouse Cedex 9, France, 31059
        • Institut Claudius Regaud - IUC Toulouse - Oncopôle
  • Germany
      • Essen, Germany, 45136
        • KEM- Brustzentrum der Kliniken Essen-Mitte
      • Frankfurt, Germany, 60389
        • Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie
      • Heidelberg, Germany, 69120
        • NCT - Nationales Centrum für Tumorerkrankungen
      • Tübingen, Germany, 72076
        • UFKT - Universitäts-Frauenklinik Tübingen
      • Ulm, Germany, 89081
        • UFU - Universitätsfrauenklinik Ulm
  • Hungary
      • Budapest, Hungary, 1032
        • Szent Margit Kórház Onkológiai Osztály
      • Budapest, Hungary, 1062
        • MH Egészségügyi Központ Onkológiai Osztály
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • VU University Medical Center
      • Geleen, Netherlands, 6162
        • Zuyderland MC
      • Groningen, Netherlands, 9700
        • UMCG Medisch Centrum Groningen
      • Leidschendam, Netherlands, 2262 BA
        • HMC Antoniushove
      • Maastricht, Netherlands, 6202
        • MUMC Medical Oncology department
      • Rotterdam, Netherlands, 3075
        • Erasmus MC
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum
  • Poland
      • Gdynia, Poland, 81 - 519
        • Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James' Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel + IMP321 at the RPTD
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)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
Drug: Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
Active Comparator: Comparator: Paclitaxel + 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
Drug: Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
Drug: Placebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stage 1 to determine the recommended phase two dose for the randomised phase
Time Frame: Up to 12 months
Up to 12 months
Assessment of Progression-Free Survival (PFS)
Time Frame: Up to 37 month
Up to 37 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the safety and tolerability of IMP321 as compared to placebo
Time Frame: Up to 19 months
Up to 19 months
Assessment of the overall survival (OS)
Time Frame: Up to 48 month
Up to 48 month
Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax]
Time Frame: Up to 12 months
Up to 12 months
Assessment of the change in quality of life (QOL)
Time Frame: Up to 37 months
Up to 37 months
Evaluation of the time to next treatment
Time Frame: Up to 37 months
Up to 37 months
Evaluation of objective response rate (ORR)
Time Frame: Up to 37 months
Up to 37 months
Evaluation of stable disease
Time Frame: Up to 37 months
Up to 37 months

Other Outcome Measures

Outcome Measure
Time Frame
Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage
Time Frame: Up to 37 months
Up to 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immutep S.A.S.

Investigators

  • Study Director: Immutep S.A.S, Immutep S.A.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 22, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP321 P011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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