Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

September 15, 2023

Primary Completion Date

July 17, 2029

Study Completion Date

July 18, 2029

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Ociperlimab

900 mg intravenously (IV) every 3 weeks (Q3W)

DRUG

Tislelizumab

200 mg intravenously (IV) Q3W

DRUG

Paclitaxel

90 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days

DRUG

Nab-paclitaxel

100 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days

DRUG

Carboplatin

AUC 2 intravenously (IV) on Days 1 and 8 every 21 days

DRUG

Placebo

normal saline intravenously (IV) Q3W

DRUG

Pembrolizumab

200 mg intravenously (IV) Q3W

DRUG

Gemcitabine

1000 mg/m2 intravenously (IV) on Days 1 and 8 every 21 days

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY