45
Participants
Start Date
September 2, 2022
Primary Completion Date
October 31, 2025
Study Completion Date
October 31, 2026
Pembrolizumab
In the induction phase, participants will receive a single intravenous infusion of pembrolizumab 400 mg prior to chemoradiotherapy. In the Maintenance Phase, participants will receive pembrolizumab 400 mg every 42 days for 8 cycles.
Olaparib
In the induction phase, participants will receive daily oral olaparib 150 mg two times a day for 3 weeks prior to chemoradiotherapy. In the Maintenance Phase, participants will receive daily olaparib 150 mg two times a day for up to 48 weeks.
Cisplatin
"In the chemoradiation phase, participants will receive weekly intravenous cisplatin infusion, 40 mg/m2 over 7 weeks.~In the chemoradiation phase, standard of care radiation therapy and chemotherapy will be administered, for a total of 7 weeks. Radiation therapy is done on daily basis (excluding weekends), and chemotherapy therapy will involve cisplatin infusion once weekly."
IMRT (intensity modulated radiation therapy)
In the chemoradiation phase, participants will receive 70 Gray external beam radiotherapy, at 2 Gray/fraction dose, 35 fractions, delivered once a day, on weekdays, using Intensity Modulated Radiotherapy Treatments or proton radiotherapy techniques, over 7 weeks.
RECRUITING
UNC Lineberger, Chapel Hill
RECRUITING
Medical University of South Carolina (MUSC), Charleston
RECRUITING
University of Louisville, Brown Cancer Center, Louisville
RECRUITING
Indiana University Simon Comprehensive Cancer Center, Indianapolis
Merck Sharp & Dohme LLC
INDUSTRY
UNC Lineberger Comprehensive Cancer Center
OTHER