Study on Pembrolizumab and Olaparib for Locally Advanced Head and Neck Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05366166

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and olaparib, given before and after standard chemoradiation therapy to treat locally advanced head and neck cancer. These drugs are approved for head and neck cancer, but not yet approved to be used together for this purpose.

Patient Parameters

Program Overview

The study aims to see if using pembrolizumab and olaparib, along with standard chemoradiation therapy, can improve treatment outcomes for patients with locally advanced head and neck cancer. The trial will test the safety and effectiveness of adding these drugs before and after the usual treatment, which includes radiation and chemotherapy with cisplatin.

Description

This study is for patients with locally advanced head and neck cancer, particularly those with HPV-negative or high-risk HPV-positive types. The standard treatment is chemoradiotherapy, which combines chemotherapy and radiation. This trial will add pembrolizumab, an immune therapy drug, and olaparib, a drug that targets cancer cell repair mechanisms, to the standard treatment.

The treatment is divided into three phases:

  1. Induction Phase: Participants receive one dose of pembrolizumab and take olaparib tablets for 21 days.
  2. Chemoradiation Phase: Participants undergo daily radiation therapy (except weekends) and weekly cisplatin infusions for 7 weeks.
  3. Maintenance Phase: Participants receive pembrolizumab every 6 weeks and take olaparib tablets twice daily for up to 8 cycles, each lasting 42 days.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Must provide written consent to participate and allow access to personal health information.
  • Must be willing and able to follow study procedures, including a pre-study biopsy unless enough previous tissue samples are available.
  • Must have a confirmed diagnosis of specific types of advanced head and neck cancer.
  • Must have at least one tumor that can be measured by scans.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must not have had previous treatments aimed at curing this cancer and must not be participating in another study or have used an investigational device recently.
  • Must not have evidence of cancer spread beyond the head and neck area.

Exclusion Criteria

  • Cannot have other types of cancer that might interfere with the study, except for certain cases of head and neck cancer treated less than 3 years ago.
  • Cannot be ineligible for cisplatin treatment.
  • Cannot have severe, uncontrolled medical conditions or infections.
  • Cannot have difficulty swallowing pills before starting the study treatment.
  • Cannot be using systemic steroids for reasons other than managing specific immune-related symptoms.

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