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IMP321 as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

This study is currently recruiting participants.
Verified October 2017 by Immutep S.A.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02614833
First Posted: November 25, 2015
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Prima BioMed Ltd
Information provided by (Responsible Party):
Immutep S.A.
  Purpose
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.

Condition Intervention Phase
Adenocarcinoma Breast Stage IV Biological: IMP321 Drug: Placebo Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immutep S.A.:

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

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

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

Estimated Enrollment: 241
Study Start Date: December 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: Placebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
Drug: Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, endokrine therapy within 1 week 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614833


Contacts
Contact: Immutep S.A.S Parc Club Orsay 2, rue Jean Rostand 91893 Orsay cedex France enquiries@primabiomed.com.au

Locations
Belgium
AZ Sint-Jan Burgge-Oostende Recruiting
Brugge, Belgium, 8000
Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique Recruiting
Brussel, Belgium, 1200
AZ Sint-Maarten Recruiting
Duffel, Belgium, 2570
Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit Recruiting
Edegem, Belgium, 2650
UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre Recruiting
Leuven, Belgium, 3000
Centre Hospitalier Universitaire Sart Tilman Oncologie médicale Recruiting
Liège, Belgium, 4000
Clinique Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research Recruiting
Wilrijk, Belgium, 2610
France
Institut de Cancérologie de la Loire Not yet recruiting
Saint Priest en Jarez, France, 42271
Institut Curie / Centre René Huguenin Not yet recruiting
Saint-Cloud, France, 92210
Institut Claudius Regaud - IUC Toulouse - Oncopôle Not yet recruiting
Toulouse Cedex 9, France, 31059
Germany
HELIOS Klinikum Berlin-Buch Gynecologic Oncology and Obstetrics, Head of the Interdisciplinary, Breast Cancer Center Recruiting
Berlin, Germany, 13125
KEM- Brustzentrum der Kliniken Essen-Mitte Not yet recruiting
Essen, Germany, 45136
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie Not yet recruiting
Frankfurt, Germany, 60389
NCT - Nationales Centrum für Tumorerkrankungen Not yet recruiting
Heidelberg, Germany, 69120
UFKT - Universitäts-Frauenklinik Tübingen Recruiting
Tübingen, Germany, 72076
UFU - Universitätsfrauenklinik Ulm Not yet recruiting
Ulm, Germany, 89081
Hungary
Szent Margit Kórház Onkológiai Osztály Recruiting
Budapest, Hungary, 1032
MH Egészségügyi Központ Onkológiai Osztály Recruiting
Budapest, Hungary, 1062
DE KK Onkológiai Klinika Recruiting
Debrecen, Hungary, 4032
Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Centrum Kaposvár Recruiting
Kaposvár, Hungary, 7400
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands, 2625
Zuyderland MC Recruiting
Geleen, Netherlands, 6162
UMCG Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9700
MUMC Medical Oncology department Recruiting
Maastricht, Netherlands, 6202
Erasmus MC Recruiting
Rotterdam, Netherlands, 3075
VieCuri Medisch Centrum Recruiting
Venlo, Netherlands, 5912 BL
Poland
Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni Active, not recruiting
Gdynia, Poland, 81 - 519
University Centre for Ophthalmology and Oncology Recruiting
Katowice, Poland, PL-40-514
Specjalistyczna Praktyka Recruiting
Warsaw, Poland, 02-954
Military Institute of Medicine, Oncology Dept Recruiting
Warsaw, Poland, 04-141
United Kingdom
The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology Recruiting
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Immutep S.A.
Prima BioMed Ltd
Investigators
Study Director: Immutep S.A.S Immutep S.A.S
  More Information

Responsible Party: Immutep S.A.
ClinicalTrials.gov Identifier: NCT02614833     History of Changes
Other Study ID Numbers: IMP321 P011
First Submitted: November 5, 2015
First Posted: November 25, 2015
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Immutep S.A.:
Hormone receptor positive

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action