Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Dwight Owen
CONTACT
Amber Ryba
CONTACT
Lead
Dwight Owen
With
PRIMARY OBJECTIVE: I. To estimate the efficacy of atezolizumab and temozolomide in two dosing schedules for patients with metastatic small-cell lung cancer (SCLC) who progress after chemoimmunotherapy. SECONDARY OBJECTIVES: I. To evaluate the safety profile and toxicity of combination atezolizumab and temozolomide in two dosing schedules as per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. II. To evaluate the progression free survival (PFS) and overall survival (OS) of patients treated with combination atezolizumab and temozolomide. III. To evaluate the intracranial PFS rate at 6 months (icPFS6) of patients with SCLC treated with atezolizumab and temozolomide. CORRELATIVE/EXPLORATORY OBJECTIVES: I. Explore association of myeloid-derived suppressor cell (MDSC) levels at baseline biomarker status from tumor biopsy samples and peripheral blood and correlate these with clinical parameters (including overall response rate \[ORR\], OS and toxicity). II. To evaluate changes in MDSC induced by different dosing of temozolomide. III. To explore post-translational modifications of PD-L1 by mass spectrometry. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 and temozolomide orally (PO) once daily (QD) on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 3 months thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
