Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy
NCT ID: NCT05747794
Last Updated: 2024-12-17
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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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
849 participants
INTERVENTIONAL
2023-05-22
2027-07-31
Brief Summary
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The main questions it aims to answer are:
* What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
* Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone?
In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled).
The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Detailed Description
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The main objectives of the dose optimization lead-in (phase 2) are to evaluate and compare the safety and tolerability of 2 different dose levels of efti (30 mg and 90 mg) combined with paclitaxel, and to define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for the phase 3 part of the trial. Recruitment to the dose-optimization lead-in will be considered complete when 29 participants per cohort are randomized and considered evaluable for OBD analysis.
The main objective of the phase 3 is to demonstrate that overall survival (OS) is superior in participants treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo. Approximately 771 participants will be randomized 2:1 to Arm A (active arm): paclitaxel + efti at OBD and Arm B (control arm): paclitaxel + placebo. The exact patient population will be defined after determination of the OBD.
The duration of the trial will be approximately 24 months for the dose optimization lead-in component and 60 months for the phase 3 component. The phase 3 will start prior to the completion of the phase 2 (once the OBD has been defined).
It is planned to conduct the trial at up to 20 sites in up to 4 countries across North America and Europe for the lead-in and at up to 150 sites in up to 25 countries across North America, Europe, Latin America and the Asian Pacific region for the phase 3.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
eftilagimod alpha 30mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.
eftilagimod alpha
APC activator, MHC II agonist
Paclitaxel
paclitaxel will be given as standard of care (chemotherapy)
open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
eftilagimod alpha 90mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.
eftilagimod alpha
APC activator, MHC II agonist
Paclitaxel
paclitaxel will be given as standard of care (chemotherapy)
Phase 3: eftilagimod alpha + paclitaxel
eftilagimod alpha s.c. (OBD) + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.
eftilagimod alpha
APC activator, MHC II agonist
Paclitaxel
paclitaxel will be given as standard of care (chemotherapy)
Phase 3: placebo + paclitaxel
placebo s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.
Paclitaxel
paclitaxel will be given as standard of care (chemotherapy)
placebo
placebo matching eftilagimod alpha
Interventions
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eftilagimod alpha
APC activator, MHC II agonist
Paclitaxel
paclitaxel will be given as standard of care (chemotherapy)
placebo
placebo matching eftilagimod alpha
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
* Participants with HR- MBC (i.e. triple-negative breast cancer \[TNBC\]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
* ECOG performance status 0-1
* Expected survival longer than three months
Exclusion Criteria
* Participants with HR+ MBC who have received \<1 line of ET based therapy in the metastatic setting
* Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
* TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
* Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
18 Years
ALL
No
Sponsors
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Immutep S.A.S.
INDUSTRY
Responsible Party
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Locations
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The Oncology Institute
Whittier, California, United States
The George Washington University Cancer Center
Washington D.C., District of Columbia, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States
Oncology Consultants
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
AZ Sint-Jan Brugge Oostende av
Bruges, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hopital de Charleroi - Hopital Notre Dame
Charleroi, , Belgium
Universitair Ziekenhuizen Antwerpen
Edegem, , Belgium
Centre Hospitalier de l'Ardenne
Libramont, , Belgium
Clinique Saint-Pierre- Ottignies
Ottignies-Louvain-la-Neuve, , Belgium
ARENSIA Exploratory Medicine LLC
Tbilisi, , Georgia
ARENSIA Exploratory Medicine Phase I Unit
Chisinau, , Moldova
Institut Català d'Oncologia
Badalona, , Spain
VHIO - Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Parc Taulí Hospital Universitari
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de Jaén
Jaén, , Spain
Unidad Ensayos Clínicos Oncología Fundació IRB Lleida
Lleida, , Spain
START Madrid - FJD, Hospital Fundación Jiménez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Other Identifiers
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2022-003323-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AIPAC-003
Identifier Type: -
Identifier Source: org_study_id