PACTR202404480503746
Not yet recruiting
Phase 2
A Phase II, Multicenter, Randomized, Double-Blind 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
ConditionsCancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Hoffmann La Roche
- Enrollment
- 160
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Metastatic or locally advanced unresectable, histologically documented triple\-negative breast cancer (TNBC) (absence of HER2\-over\-expression, ER, and PgR expression by local assessment)
- •HER2\-low\-status
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (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 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
- •Negative HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on anti\-retroviral therapy, have a CD4 count \= 200/uL, and have an undetectable viral load
- •Negative hepatitis B surface antigen (HBsAg) test at screening
Exclusion Criteria
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 4 months after the final dose of tobemstomig or pembrolizumab, and 6 months after the final dose of nab\-paclitaxel
- •Poor venous access
- •History of malignancy within 5 years prior to consent, except for the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5\-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Hypercalcemia or hypercalcemia that is symptomatic
- •Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis (granulomatosis with polyangiitis), Sjögren syndrome, Guillain\-Barré syndrome, or multiple sclerosis
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug\-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •Active tuberculosis (TB)
Outcomes
Primary Outcomes
Not specified
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