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.
Lead
Roswell Park Cancer Institute
PRIMARY OBJECTIVES: I. To evaluate the 1-year progression-free survival rate with 200mg pembrolizumab administered every 3 weeks compared to 200mg pembrolizumab administered every 12 weeks. SECONDARY OBJECTIVES: I. To assess overall survival between the two treatment groups. II. To assess the serious adverse event profiles between the two treatment groups. EXPLORATORY OBJECTIVES: I. To evaluate circulating biomarkers of treatment response and resistance. II. To characterize fecal microbiotic profile and to correlate those results with tumor characteristics and antitumor immune responses. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for at least 12 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
