Adenocarcinoma Breast Stage IVPhase 2NCT02614833
IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
A Phase 2 study testing IMP321 (eftilagimod alpha) and Paclitaxel in people with Adenocarcinoma Breast Stage IV, run by Immutep S.A.S. at 29 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenocarcinoma Breast Stage IV
- What is being tested?
- IMP321 (eftilagimod alpha) and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Dec 2015to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Belgium8 sites
AZ Sint-Jan Burgge-Oostende
Bruges, 8000
Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique
Brussels, 1200
AZ Sint-Maarten
Duffel, 2570
Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit
Edegem, 2650
UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre
Leuven, 3000
Clinique Sainte-Elisabeth
Namur, 5000
AZ Nikolass
Sint-Niklaas, 9100
GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research
Wilrijk, 2610
Netherlands7 sites
VU University Medical Center
Amsterdam, 1081
Zuyderland MC
Geleen, 6162
UMCG Medisch Centrum Groningen
Groningen, 9700
HMC Antoniushove
Leidschendam, 2262 BA
MUMC Medical Oncology department
Maastricht, 6202
Erasmus MC
Rotterdam, 3075
VieCuri Medisch Centrum
Venlo, 5912 BL
Germany5 sites
KEM- Brustzentrum der Kliniken Essen-Mitte
Essen, 45136
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie
Frankfurt, 60389
NCT - Nationales Centrum für Tumorerkrankungen
Heidelberg, 69120
UFKT - Universitäts-Frauenklinik Tübingen
Tübingen, 72076
UFU - Universitätsfrauenklinik Ulm
Ulm, 89081
France3 sites
Institut Curie / Centre René Huguenin
Saint-Cloud, 92210
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
Institut Claudius Regaud - IUC Toulouse - Oncopôle
Toulouse, 31059
United Kingdom3 sites
St James' Institute of Oncology
Leeds, West Yorkshire, LS9 7TF
The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology
Manchester, M20 4BX
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Hungary2 sites
Szent Margit Kórház Onkológiai Osztály
Budapest, 1032
MH Egészségügyi Központ Onkológiai Osztály
Budapest, 1062
Poland1 site
Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni
Gdynia, 81 - 519
About this study
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
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.
Read the 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.
- Conditions
- Adenocarcinoma Breast Stage IV
- Being tested
- IMP321 (eftilagimod alpha), Placebo, Paclitaxel
- Keywords
- Hormone receptor positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP321 (eftilagimod alpha)Biological
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
PlaceboDrug
In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
PaclitaxelDrug
Paclitaxel will be given in both treatment arms (classified as Non IMP)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 to determine the recommended phase two dose for the randomised phase
Measured: Up to 12 months
Assessment of Progression-Free Survival (PFS)
Measured: Up to 37 month
Secondary outcomes (7)
Assessment of the safety and tolerability of IMP321 as compared to placebo
Measured: Up to 19 months
Assessment of the overall survival (OS)
Measured: Up to 48 month
Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax]
Measured: Up to 12 months
Assessment of the change in quality of life (QOL)
Measured: Up to 37 months
Evaluation of the time to next treatment
Measured: Up to 37 months
Evaluation of objective response rate (ORR)
Measured: Up to 37 months
Evaluation of stable disease
Measured: Up to 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma Breast Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immutep S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Immutep S.A.S, Study director, Immutep S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614833
- Sponsor's protocol ID
- IMP321 P011
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2015
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
PubMed 41811823
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02614833
- Acronym / sponsor ID
- IMP321 P011
- Conditions
- Adenocarcinoma Breast Stage IV
- Keywords
- Hormone receptor positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Immutep S.A.S.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel + IMP321 at the RPTD | Experimental | Biological: IMP321 (eftilagimod alpha), Drug: PaclitaxelThe 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 |
| Comparator: Paclitaxel + Placebo | Active comparator | Drug: Placebo, Drug: PaclitaxelThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMP321 (eftilagimod alpha)In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo | Biological | Paclitaxel + IMP321 at the RPTD |
| PlaceboIn the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD | Drug | Comparator: Paclitaxel + Placebo |
| PaclitaxelPaclitaxel will be given in both treatment arms (classified as Non IMP) | Drug | Comparator: Paclitaxel + Placebo, Paclitaxel + IMP321 at the RPTD |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 41811823Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Immutep S.A.S study director
Immutep S.A.S.
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMP321 (eftilagimod alpha) and Paclitaxel in people with Adenocarcinoma Breast Stage IV, run by Immutep S.A.S. at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Belgium, Netherlands, Germany, France, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 to determine the recommended phase two dose for the randomised phase (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.