37
Participants
Start Date
September 11, 2018
Primary Completion Date
June 1, 2022
Study Completion Date
March 13, 2025
M7824
Arm A \& B: 2400mg intravenous (IV) over up to 120 minutes every 3 weeks on a 3-week cycle. Arm C: 1200 mg IV over 1 hour every 2 weeks on a 4-week cycle.
Topotecan
Arm B: 1 mg/m(2) intravenous (IV) over 30 minutes days 1-5 on a 3-week cycle.
Temozolomide
Arm C and progressive disease patients on Arm A: 200 mg/m(2) by mouth (PO) days 1-5 on a 4-week cycle.
EKG
Screening and baseline.
CT scan
Computed tomography (CT) scan performed at Screening and after every 2 cycles (6 weeks) per Study Calendar for Arm B 3.5.2, Arm B 3.5.2, and/or Arm C 3.5.3 as applicable.
PET scan
Positron emission tomography (PET) not mandatory - If a computed tomography (CT) scan is not sufficient to assess response, a PET scan may be added per Study Calendar for Arm A 3.5.1, Arm B 3.5.2, and/or Arm C 3.5.3 as applicable.
Acetaminophen
For infusion related reaction, 500-1000 mg by mouth (PO) prior to infusion.
Antihistamines
As medically indicated.
Diphenhydramine
For infusion related reaction, 50 mg by mouth (PO) prior to infusion.
Dexamethasone
As medically indicated.
Epinephrine
As medically indicated.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH