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

I

Immutep

Status and phase

Completed
Phase 2

Conditions

Adenocarcinoma Breast Stage IV

Treatments

Drug: Paclitaxel
Biological: IMP321 (eftilagimod alpha)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02614833
IMP321 P011

Details and patient eligibility

About

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.

Full 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.

Enrollment

242 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

242 participants in 2 patient groups

Paclitaxel + IMP321 at the RPTD
Experimental group
Description:
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
Treatment:
Biological: IMP321 (eftilagimod alpha)
Drug: Paclitaxel
Comparator: Paclitaxel + Placebo
Active Comparator group
Description:
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
Treatment:
Drug: Placebo
Drug: Paclitaxel

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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