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IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614833
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Immutep S.A.

Tracking Information
First Submitted Date  ICMJE November 5, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date November 12, 2020
Study Start Date  ICMJE December 2015
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2015)
Assessment of Progression-Free Survival (PFS) [ Time Frame: Up to 37 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2015)
  • Assessment of the safety and tolerability of IMP321 as compared to placebo (adverse events and serious adverse events, physical examinations, vital signs, safety lab, ECG) [ Time Frame: Up to 19 months ]
    Safety data will be summarised for the safety population. The baseline value for safety analysis is defined as the value collected at the time closest to and prior to the start of study drug.The number and percentage of patients with at least 1 AE will be summarised by preferred term and system organ class
  • Assessment of the overall survival (OS) [ Time Frame: Up to 37 month ]
  • Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax] [ Time Frame: Up to 6 months ]
    The pharmacokinetic population will take all patients into account who receieved IMP321 in stage 1 with sufficient plasma concentration data to calculate reliable estimates of at least one parameter
  • Stage 1: Evaluation of the pharmacokinetic e.g. Area Under the Curve [AUC] [ Time Frame: Up to 6 months ]
  • Stage 1: Evaluation of the pharmacokinetic e.g. time to reach Cmax [tmax] [ Time Frame: Up to 6 months ]
  • Stage 1: Evaluation of the pharmacokinetic e.g. systemic clearance [CL] [ Time Frame: Up to 6 months ]
  • Stage 1: Evaluation of the pharmacokinetic e.g. elimination half-life[t1/2] [ Time Frame: Up to 6 months ]
  • Stage 1: Evaluation of the pharmacokinetic e.g. volume of distribution [VD] [ Time Frame: Up to 6 months ]
  • Assessment of the change in quality of life (QOL) [ Time Frame: Up to 37 months ]
  • Evaluation of the time to next treatment. This is defined as the time between the date of first study treatment administration and the start of the next anti-cancer treatment [ Time Frame: Up to 37 months ]
  • Evaluation of objective response rate (ORR) [ Time Frame: Up to 37 months ]
  • Evaluation of stable disease. This is defined as the time (days) from the date study administration to the date of disease progression or death (if death occured before progression) [ Time Frame: Up to 37 months ]
Current Other Pre-specified Outcome Measures
 (submitted: January 13, 2017)
Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage [ Time Frame: Up to 37 months ]
Original Other Pre-specified Outcome Measures
 (submitted: November 22, 2015)
  • Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage. Blood samples of this patients will be taken to assess Monocytes/Lymphocytes Count Cell Activation [ Time Frame: Up to 37 months ]
  • Tumour biomarkers will be assessed in archival tissue obtained from patients on a voluntary basis. [ Time Frame: Once at screening ]
    Archival tumour tissue will be obtained from patients in the study on a voluntary basis.Specific markers that will be assessed include the level of tumour-infiltrating immune cells and associated activation markers and Tumour cell molecular profiling.
 
Descriptive Information
Brief Title  ICMJE IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma Breast Stage IV
Intervention  ICMJE
  • Biological: IMP321 (eftilagimod alpha)
    In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
  • 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)
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: IMP321 (eftilagimod alpha)
    • Drug: Paclitaxel
  • 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
    Interventions:
    • Drug: Placebo
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
241
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2015)
211
Estimated Study Completion Date  ICMJE May 2021
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Hungary,   Netherlands,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614833
Other Study ID Numbers  ICMJE IMP321 P011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immutep S.A.
Study Sponsor  ICMJE Immutep S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Immutep S.A.S Immutep S.A.S
PRS Account Immutep S.A.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP