NCT05809895

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

AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) \[combined positive score (CPS) ≥10\], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, Phase II study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and chemotherapy as first-line treatment for participants with advanced TNBC whose tumors express PD-L1 (CPS ≥ 10). Additionally, the efficacy and safety of the triple combination (ociperlimab + tislelizumab + chemotherapy) will be assessed in Arm D (a separate single-arm, open-label cohort) in 30 participants with advanced TNBC whose tumors express PD-L1 (CPS ≥ 1 to \< 10). Study treatment will continue until the participant experiences one of the following: disease progression per investigator's assessment by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, unacceptable toxicity, pregnancy, treatment is discontinued at the discretion of the investigator or participant, start of a new antineoplastic therapy, withdrawal of consent, lost to follow-up, death, or study is terminated by the sponsor.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-15
• Primary completion: 2029-07-17
• Completion: 2029-07-18
• First posted: 2023-04-12
• Last updated: 2023-07-24

Regulatory

• FDA-regulated drug study