NCT02614833

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Immutep S.A.S. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma Breast Stage IV

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-03-01
• Completion: 2021-05-01
• First posted: 2015-11-25
• Last updated: 2021-10-05

Locations

29 sites across 7 countries: Belgium, France, Germany, Hungary, Netherlands, Poland, United Kingdom