Clinical Trials /

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

NCT02614833

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: IMP321 as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: IMP321 P011
  • NCT ID: NCT02614833

Conditions

  • Adenocarcinoma Breast Stage IV

Interventions

DrugSynonymsArms
IMP321Paclitaxel + IMP321 at the RPTD
PlaceboComparator: Paclitaxel + Placebo
PaclitaxelPaclitaxel + IMP321 at the RPTD

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Paclitaxel + IMP321 at the RPTDExperimentalThe 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
  • Paclitaxel
Comparator: Paclitaxel + PlaceboActive ComparatorThe 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
  • Paclitaxel

Eligibility Criteria

        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, endokrine therapy within 1 week 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Stage 1 to determine the recommended phase two dose for the randomised phase
Time Frame:Up to 12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Assessment of the safety and tolerability of IMP321 as compared to placebo
Time Frame:Up to 19 months
Safety Issue:
Description:
Measure:Assessment of the overall survival (OS)
Time Frame:Up to 48 month
Safety Issue:
Description:
Measure:Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax]
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Assessment of the change in quality of life (QOL)
Time Frame:Up to 37 months
Safety Issue:
Description:
Measure:Evaluation of the time to next treatment
Time Frame:Up to 37 months
Safety Issue:
Description:
Measure:Evaluation of objective response rate (ORR)
Time Frame:Up to 37 months
Safety Issue:
Description:
Measure:Evaluation of stable disease
Time Frame:Up to 37 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Immutep S.A.

Trial Keywords

  • Hormone receptor positive

Last Updated

September 7, 2017