BAY 1895344 + Radiation + Pembrolizumab for Head and Neck Cancer

This trial tests a new treatment combination to manage head and neck cancer that has recurred and cannot be surgically removed. The treatment includes elimusertib, an experimental drug that might block enzymes aiding cancer growth; precise radiation targeting tumors; and pembrolizumab, which boosts the immune system to fight cancer. It targets individuals with recurrent, inoperable squamous cell head and neck cancer who have previously undergone treatments like chemotherapy or radiation. The trial aims to determine the best dose and assess any benefits or side effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

The trial protocol does not specify if you need to stop your current medications. However, if you are taking medications that interact with CYP3A4, you may need to switch to alternatives. It's best to discuss your current medications with the study team.

Research has shown that pembrolizumab, one of the treatments in this trial, has been used successfully in patients with head and neck cancer. One study found it improved the time patients lived without the cancer worsening, without causing new safety problems. This suggests that pembrolizumab is generally safe, with no unexpected side effects reported.

For elimusertib, detailed information about its safety in humans is limited. However, as the trial is in an early stage, researchers are closely monitoring its safety and determining the best dose.

Stereotactic body radiation therapy is another part of this trial. This precise type of radiation treatment aims to protect healthy tissues and is generally well-tolerated by patients.

Researchers are excited about this treatment combination for head and neck cancer because it integrates Elimusertib, a new active ingredient, with Pembrolizumab and Stereotactic Body Radiation Therapy (SBRT). Elimusertib targets cancer cells by inhibiting a specific enzyme involved in DNA repair, potentially enhancing the effectiveness of radiation therapy. This approach is different from standard treatments like surgery or chemotherapy, which don't target the DNA repair mechanism. By combining Pembrolizumab, an immune checkpoint inhibitor, with targeted DNA repair disruption and precise radiation, this treatment could improve outcomes by more effectively attacking cancer cells while sparing healthy tissue.

Research shows that pembrolizumab, one of the treatments in this trial, effectively treats head and neck squamous cell cancer (HNSCC). Studies have found that pembrolizumab can extend patients' lives, particularly when used as the initial treatment, making it a common first choice for this condition. Pembrolizumab has also proven effective in real-life situations for patients with recurrent or difficult-to-remove HNSCC. In this trial, participants will receive pembrolizumab alongside elimusertib and stereotactic body radiation therapy (SBRT). Although less information exists about elimusertib, it likely works by blocking certain enzymes that cancer cells need to grow. Overall, combining these treatments with precise radiation aims to effectively target and manage cancer in these patients.¹⁵⁶⁷⁸