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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

NCT05809895 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-07-24

No results posted yet for this study

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.

Conditions

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 & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2029-07-17
Completion
2029-07-18
FDA Drug
Yes

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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 NCT05809895 on ClinicalTrials.gov