Adenocarcinoma Breast Stage IV Clinical Trial
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
| NCT number | NCT02614833 |
| Other study ID # | IMP321 P011 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | December 2015 |
| Est. completion date | May 2021 |
| Verified date | October 2021 |
| Source | Immutep S.A.S. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 242 |
| Est. completion date | May 2021 |
| Est. primary completion date | March 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ Sint-Jan Burgge-Oostende | Brugge | |
| Belgium | Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique | Brussel | |
| Belgium | AZ Sint-Maarten | Duffel | |
| Belgium | Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit | Edegem | |
| Belgium | UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre | Leuven | |
| Belgium | Clinique Sainte-Elisabeth | Namur | |
| Belgium | AZ Nikolass | Sint-Niklaas | |
| Belgium | GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research | Wilrijk | |
| France | Institut de Cancérologie de la Loire | Saint Priest en Jarez | |
| France | Institut Curie / Centre René Huguenin | Saint-Cloud | |
| France | Institut Claudius Regaud - IUC Toulouse - Oncopôle | Toulouse Cedex 9 | |
| Germany | KEM- Brustzentrum der Kliniken Essen-Mitte | Essen | |
| Germany | Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie | Frankfurt | |
| Germany | NCT - Nationales Centrum für Tumorerkrankungen | Heidelberg | |
| Germany | UFKT - Universitäts-Frauenklinik Tübingen | Tübingen | |
| Germany | UFU - Universitätsfrauenklinik Ulm | Ulm | |
| Hungary | MH Egészségügyi Központ Onkológiai Osztály | Budapest | |
| Hungary | Szent Margit Kórház Onkológiai Osztály | Budapest | |
| Netherlands | VU University Medical Center | Amsterdam | |
| Netherlands | Zuyderland MC | Geleen | |
| Netherlands | UMCG Medisch Centrum Groningen | Groningen | |
| Netherlands | HMC Antoniushove | Leidschendam | |
| Netherlands | MUMC Medical Oncology department | Maastricht | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | VieCuri Medisch Centrum | Venlo | |
| Poland | Kierownik Oddzialu Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni | Gdynia | |
| United Kingdom | St James' Institute of Oncology | Leeds | West Yorkshire |
| United Kingdom | The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology | Manchester | |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Immutep S.A.S. |
Belgium, France, Germany, Hungary, Netherlands, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage | Up to 37 months | ||
| Primary | Stage 1 to determine the recommended phase two dose for the randomised phase | Up to 12 months | ||
| Primary | Assessment of Progression-Free Survival (PFS) | Up to 37 month | ||
| Secondary | Assessment of the safety and tolerability of IMP321 as compared to placebo | Up to 19 months | ||
| Secondary | Assessment of the overall survival (OS) | Up to 48 month | ||
| Secondary | Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax] | Up to 12 months | ||
| Secondary | Assessment of the change in quality of life (QOL) | Up to 37 months | ||
| Secondary | Evaluation of the time to next treatment | Up to 37 months | ||
| Secondary | Evaluation of objective response rate (ORR) | Up to 37 months | ||
| Secondary | Evaluation of stable disease | Up to 37 months |