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.
Title
- Brief Title: IMP321 (Eftilagimod Alpha) 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
Drug | Synonyms | Arms |
---|
IMP321 (eftilagimod alpha) | | Paclitaxel + IMP321 at the RPTD |
Placebo | | Comparator: Paclitaxel + Placebo |
Paclitaxel | | Comparator: Paclitaxel + Placebo |
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
Name | Type | Description | Interventions |
---|
Paclitaxel + IMP321 at the RPTD | Experimental | 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 | - IMP321 (eftilagimod alpha)
- Paclitaxel
|
Comparator: Paclitaxel + Placebo | Active Comparator | 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 | |
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, 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.
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: | Active, not recruiting |
Lead Sponsor: | Immutep S.A. |
Trial Keywords
- Hormone receptor positive
Last Updated
November 12, 2020