A Study of 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

Phase 1

Recruiting

• Conditions: Triple-Negative Breast Cancer (TNBC); MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; MedDRA version: 23.0Level: LLTClassification code: 10084066Term: Triple negative breast cancer metastatic Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502457-34-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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], For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom during the treatment period and for 4 months after the final dose of RO7247669 or pembrolizumab and 6 months after the final dose of nab-paclitaxel to avoid exposing the embryo. Male participants must refrain from donating sperm during this same period, 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, Adequate cardiovascular function, Negative human immunodeficiency virus (HIV), Negative hepatitis B surface antigen (HBsAg), Positive hepatitis B surface antibody (HBsAb) tests, and Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening, For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs during the treatment period and for 4 months after the final dose of RO7247669 or pembrolizumab and for 6 months after the final dose of nab-paclitaxel. Participants must refrain from donating eggs during this same period

Exclusion Criteria

History of malignancy within 5 years prior to consent, Poor venous access, Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, 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, Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment, Known hypersensitivity to Chinese hamster ovary cell products or to any component of the RO7247669 or pembrolizumab formulation and allergy or hypersensitivity to any component of the to nab-paclitaxel formulation, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified