This phase IV trial assesses the safety and feasibility of receiving chimeric antigen receptor (CAR) T cell therapy with YESCARTA in the outpatient setting, with fewer days spent as a patient in the hospital. YESCARTA is made from your own white blood cells, which will be modified in a laboratory to recognize and attack your lymphoma cells. Because YESCARTA is a specialized and fairly new therapy, patients currently receiving YESCARTA are typically required to spend several days in the hospital even if their treatment is well tolerated. This trial may help doctors determine if it is safe and feasible to give YESCARTA in the outpatient setting, with fewer days spent as a patient in the hospital.
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer
Multiple Cancer Types
This is a Phase Ib / II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC. The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.
Breast, Phase I