Pembrolizumab Plus Olaparib in LA-HNSCC

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 2, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
BIOLOGICAL

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.

DRUG

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.

DRUG

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."

RADIATION

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.

Trial Locations (4)

27514

RECRUITING

UNC Lineberger, Chapel Hill

29425

RECRUITING

Medical University of South Carolina (MUSC), Charleston

40202

RECRUITING

University of Louisville, Brown Cancer Center, Louisville

46202

RECRUITING

Indiana University Simon Comprehensive Cancer Center, Indianapolis

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER