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A Study of Tobemstomig/RO7247669 Combined with Nab-Paclitaxel Compared with Pembrolizumab Combined with Nab-Paclitaxel in Participants with Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
EU CTIS ID: 2022-502457-34-00
What this study is testing
To evaluate the efficacy of tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in the full analysis set (FAS) based on progression-free survival (PFS)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Metastatic or locally advanced unresectable, histologically documented TNBC [absence of human epidermal growth factor receptor 2 (HER2)-over-expression, estrogen receptor (ER), and progesterone receptor (PgR) expression by local assessment]
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). If metastatic disease (Stage IV), measurable disease outside of the bone
- No prior systemic therapy for metastatic or locally advanced unresectable TNBC
- Tumor programmed death-ligand 1 (PD-L1) expression as documented through central testing of a representative tumor tissue specimen
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function, defined by protocol-specified laboratory test results, obtained within 14 days prior to initiation of study treatment
You likely can't join if
- History of malignancy within 5 years prior to consent
- Poor venous access
- History of leptomeningeal disease
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Major surgical procedure within 4 weeks prior to initiation of study treatment
- Prior treatment with CD137 agonists or anti-cytotoxic T-lymphocyte-associated protein (CTLA) therapeutic antibodies or an anti-lymphocyte-activation gene 3 protein (LAG-3) agent
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Mexico
- Korea, Republic of
- United States
- Canada
- South Africa
- Israel
- Turkey
- Brazil
- Peru
- Australia
- Argentina
- Switzerland
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Mexico; Korea, Republic of; United States; Canada; South Africa and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.