IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
NCT ID: NCT02614833
Last Updated: 2021-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2015-12-31
2021-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
IMP321 (eftilagimod alpha)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
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
Placebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
Interventions
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IMP321 (eftilagimod alpha)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
Placebo
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Immutep S.A.S.
INDUSTRY
Responsible Party
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Principal Investigators
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Immutep S.A.S
Role: STUDY_DIRECTOR
Immutep S.A.S.
Locations
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AZ Sint-Jan Burgge-Oostende
Bruges, , Belgium
Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique
Brussels, , 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, , Belgium
Institut Curie / Centre René Huguenin
Saint-Cloud, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Institut Claudius Regaud - IUC Toulouse - Oncopôle
Toulouse, , France
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, , Germany
Szent Margit Kórház Onkológiai Osztály
Budapest, , Hungary
MH Egészségügyi Központ Onkológiai Osztály
Budapest, , Hungary
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, , Netherlands
Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni
Gdynia, , Poland
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, , United Kingdom
Countries
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Other Identifiers
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IMP321 P011
Identifier Type: -
Identifier Source: org_study_id
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