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BAY 1895344 + Radiation + Pembrolizumab for Head and Neck Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.I am not pregnant and agree to use birth control.My cancer has spread extensively.I have specific allergies or an active autoimmune disease.My cancer is a type of head and neck cancer that cannot be removed with surgery.I have received a blood transfusion within a specific timeframe.I have not received a live vaccine in the last 30 days.My cancer progressed despite receiving anti-PD-1/L1/L2 therapy, or I have not received these therapies.I can safely receive pembrolizumab treatment.I have new or worsening brain metastases or cancer in the lining of my brain.I do not have any uncontrolled illnesses.My cancer surrounds more than half of my carotid artery.My cancer has spread to my jawbone.I have another cancer that is getting worse or needs treatment.I have had more than one round of radiation therapy for head or neck cancer.I finished my radiotherapy at least 6 months ago.I have another cancer type, but it won't affect this trial's treatment.I have a history of heart issues or have been treated with heart-affecting drugs.I have had platinum-based chemotherapy or my tumor is PD-L1 positive.I have a specific type of head or neck cancer.I have not had certain antibody treatments recently.I am 18 years old or older.Your blood tests need to show certain levels within a specific range.People with HIV can join the study if they meet certain requirements.I haven't had chemotherapy, targeted therapy, or radiotherapy recently.I have an immune system condition or have been on certain medications recently.I have an active tuberculosis infection.I cannot take medications by mouth.My cancer in the head or neck area has come back or is new in a previously treated area.I have had pneumonitis or my disease got worse while on a specific treatment.I am taking medications that are strongly affected by the liver enzyme CYP3A4.
- Group 1: Treatment (pembrolizumab, BAY 1895344, SBRT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what maladies does Stereotactic Body Radiation Therapy typically provide a remedy?
"Stereotactic Body Radiation Therapy is generally administered to patients with malignant neoplasms, but can also be useful in treating unresectable melanoma, microsatellite instability high, and cases where chemotherapy has not yielded the desired outcomes."
With what outcomes is this clinical study aiming to conclude?
"The aim of this 90-day clinical trial is to establish the maximum tolerated dosage of elimusertib (BAY 1895344) in conjunction with stereotactic body radiation therapy. Secondary objectives include assessing locoregional control by competing risk analysis, cataloging adverse events according to CTCAE version 5, and calculating overall response rate based on Response Evaluation Criteria for Solid Tumors 1.1 criteria."
What is the extant number of centers that are conducting this research?
"This medical investigation is conducted at Montefiore Medical Center-Einstein Campus in Bronx, New york, Montefiore Medical Center - Moses Campus in Durham, North carolina and Duke University Medical Centre in Chicago, Illinois. Furthermore, it's being administered across 8 additional sites."
How many participants are being recruited for this medical trial?
"Affirmative. Clinicaltrials.gov has a listing indicating that this clinical trial is currently accepting participants, which first appeared on February 12th 2021 and was upgraded as recently as October 15th 2022. The recruitment effort seeks 37 candidates from 8 different medical facilities."
Are there any other empirical studies that have looked into the efficacy of Stereotactic Body Radiation Therapy?
"At the moment, 961 trials investigating Stereotactic Body Radiation Therapy are in progress. Of these live studies, 122 have entered Phase 3 and 35731 locations across the nation are conducting related research. Notably, Houston Texas has an especially high concentration of such initiatives."
What safeguards are taken to ensure the safe utilization of Stereotactic Body Radiation Therapy?
"Considering the limited amount of clinical data for Stereotactic Body Radiation Therapy, our team at Power assessed its safety with a score of 1."
Are there still opportunities to join this investigation?
"Affirmative. The clinicaltrials.gov site verifies that this research is currently in need of subjects, having been first posted on February 12th 2021 and most recently updated on October 15th 2022. They are aiming to recruit 37 patients from 8 distinct locations."
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