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Enzyme Inhibitor

BAY 1895344 + Radiation + Pembrolizumab for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Yvonne M Mowery

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%) and a life expectancy of >= 3 months

Patients must have histologically confirmed recurrent, unresectable head and neck squamous cell carcinoma, including various specific locations

Must not have

Patients with widely metastatic disease

Patients with specific allergic reactions or active autoimmune diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if they are effective in treating head and neck squamous cell cancer that has come back and cannot be removed through surgery. The drugs being tested are BAY 1895344, stereotactic body radiation therapy, and pembrolizumab. This combination of drugs may help to shrink or stabilize the cancer for a longer period of time than treatment with radiation and immunotherapy without BAY 1895344.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune system activation by pembrolizumab which could affect various organs; complications from high precision radiation potentially affecting nearby normal tissues; plus any risks associated with elimusertib that might involve blocking enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer is a type of head and neck cancer that cannot be removed with surgery.

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I am 18 years old or older.

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My cancer in the head or neck area has come back or is new in a previously treated area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread extensively.

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I have specific allergies or an active autoimmune disease.

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I have not received a live vaccine in the last 30 days.

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I have new or worsening brain metastases or cancer in the lining of my brain.

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My cancer surrounds more than half of my carotid artery.

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My cancer has spread to my jawbone.

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I have another cancer that is getting worse or needs treatment.

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I have had more than one round of radiation therapy for head or neck cancer.

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I have a specific type of head or neck cancer.

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I have an active tuberculosis infection.

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I cannot take medications by mouth.

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I have had pneumonitis or my disease got worse while on a specific treatment.

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I am taking medications that are strongly affected by the liver enzyme CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of late adverse events (Dose Expansion Phase)

Secondary study objectives

1-year overall survival

Incidence of adverse events

Locoregional control

+3 more

Other study objectives

Potential predictive biomarkers of response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, BAY 1895344, SBRT)Experimental Treatment7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030