Phase II study with nivolumab (anti-PD1) in patients with triple negative breast cancer after induction treatment.

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000020826; Therapeutic area: Diseases [C] - Cancer [C04]; Triple negative breast cancer (TNBC) patients with metastatic disease

• Registration Number: EUCTR2015-001969-49-NL
• Lead Sponsor: KI-Av

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Metastatic triple negative breast cancer with conformation of ER and HER2 negativity (ER <10%, and HER2 0,1 or 2 in the absence of amplification as determined by in situ hybridization) on a histological biopsy of a metastatic lesion
• 18 years or older
• Metastatic lesion accessible for histological biopsy (Mandatory biopsies: pre-treatment induction treatment, post-induction treatment, 12-weeks. Optional biopsies: at progression, of irradiated site)
• Maximum of three previous lines of chemotherapy for metastatic disease
• Evaluable disease according to RECIST 1.1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• known history of leptomeningeal disease localization
• history of having received other anticancer therapies within 2 weeks of start of the study drug
• history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections.
• prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody
• live vaccine within 30 days of planned start of study therapy.
• active other cancer
• positive test for hepatitis B surface virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
• current pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified