A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participa… (NCT05852691) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
United States, Argentina83 participantsStarted 2023-07-18
Plain-language summary
The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).
Who can participate
Age range18 Years
SexALL
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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
* Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAb at screening accompanied by either of the following: negative hepatitis B core antibody (HBcAb); positive HBcAb test followed by quantitative hepatitis B virus (HBV) DNA \< 500 IU/mL
* Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening
* Adequate cardiovascular function
Exclusion Criteria:
* Pregnancy or breastfeeding, …
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)