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

NCT02614833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-10-05

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma Breast Stage IV

Interventions

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)

Sponsors & Collaborators

  • Immutep S.A.S.

    lead INDUSTRY

Principal Investigators

  • Immutep S.A.S · Immutep S.A.S.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-03-31
Completion
2021-05-31

Countries

  • Belgium
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02614833 on ClinicalTrials.gov