Pembrolizumab Plus Olaparib in LA-HNSCC

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05366166
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    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 — DRUG
    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 — DRUG
    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) — RADIATION
    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.

Study Details

The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for head and neck cancer treatment. However, FDA has not approved the use of these two drugs together in treating head and neck cancer.

Key Dates

Start date
Sep 2, 2022
Status verified
Jan 2026
Primary completion
Jan 21, 2027
Completion
Nov 21, 2030

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    The participants will receive neoadjuvant and adjuvant pembrolizumab and olaparib combination plus standard of care (chemoradiation therapy) as defined in the protocol.

Primary Outcome Measure

One Year Progression Free Survival (PFS) [ Time Frame: up to 1 year from start of treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
University of Louisville, Brown Cancer CenterLouisvilleKentucky40202-
UNC LinebergerChapel HillNorth Carolina27514-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-

Find similar trials in Indianapolis, IN

By research site
Indiana University Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Louisville, Brown Cancer Center· Louisville, KYUNC Lineberger· Chapel Hill, NCMedical University of South Carolina (MUSC)· Charleston, SC

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