BAY 1895344 + Radiation + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Yvonne M. Mowery

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving BAY 1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY 1895344.

Research Team

Yvonne M. Mowery

Principal Investigator

University of Pittsburgh Cancer Institute LAO

Eligibility Criteria

Adults with recurrent, unresectable head and neck squamous cell carcinoma are eligible for this trial. They must have had disease progression on or after anti-PD-1/L1/L2 therapy or be new to such treatment. Prior radiotherapy should be completed at least 6 months before joining, and they should not have contraindications to pembrolizumab. Participants need a negative HIV test under certain conditions, no severe cardiac issues, agree to contraception if applicable, and meet specific health criteria.

Inclusion Criteria

I can care for myself and doctors expect me to live for at least 3 more months.

Patients must have a way to measure their disease according to specific guidelines.

I have had brain metastases treated and they are now stable.

Exclusion Criteria

My cancer has spread extensively.

I have specific allergies or an active autoimmune disease.

I have received a blood transfusion within a specific timeframe.

Treatment Details

Interventions

• Elimusertib (Enzyme Inhibitor)
• Pembrolizumab (Monoclonal Antibodies)
• Stereotactic Body Radiation Therapy (Radiation)

Trial Overview The trial is testing the combination of BAY 1895344 (elimusertib), stereotactic body radiation therapy, and pembrolizumab in patients with advanced head and neck cancer. It aims to find the optimal dose while assessing the potential benefits and side effects of this regimen compared to standard treatments involving radiation and immunotherapy without elimusertib.

Participant Groups

Group I: Treatment (pembrolizumab, BAY 1895344, SBRT) Experimental Treatment 7 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients undergo SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or PET-CT scan and collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School