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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 : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Immutep S.A.

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Breast Stage IV Biological: IMP321 (eftilagimod alpha) Drug: Placebo Drug: Paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Paclitaxel

Arm Intervention/treatment
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
Biological: IMP321 (eftilagimod alpha)
In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo

Drug: Paclitaxel
Paclitaxel will be given in both treatment arms (classified as Non IMP)

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
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)




Primary Outcome Measures :
  1. Stage 1 to determine the recommended phase two dose for the randomised phase [ Time Frame: Up to 12 months ]
  2. Assessment of Progression-Free Survival (PFS) [ Time Frame: Up to 37 month ]

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

Other Outcome Measures:
  1. Stage 1: assessment of Immuno-monitoring in a defined subset of 60 patients during the randomised stage [ Time Frame: Up to 37 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614833


Locations
Show Show 33 study locations
Sponsors and Collaborators
Immutep S.A.
Investigators
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Study Director: Immutep S.A.S Immutep S.A.S

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Responsible Party: Immutep S.A.
ClinicalTrials.gov Identifier: NCT02614833    
Other Study ID Numbers: IMP321 P011
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Keywords provided by Immutep S.A.:
Hormone receptor positive
Additional relevant MeSH terms:
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Adenocarcinoma
Breast Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action