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CUE-101 + Keytruda for Head and Neck Squamous Cell Carcinoma
Study Summary
This trial is testing a new drug, CUE-101, as a possible treatment for HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
- Head and Neck Cancers
- Carcinoma
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- Results from medical tests show certain abnormalities or conditions.You have advanced head and neck cancer that has worsened after receiving at least one type of treatment. You must have already received platinum-based chemotherapy and/or pembrolizumab as a first-line treatment.You fully understand the study and have agreed to participate. You are also willing to follow the study procedures and provide the necessary research samples.You need to have a specific genetic marker called HLA A*0201 which will be tested by a designated laboratory chosen by the study sponsor.You are physically able to perform daily activities without assistance, or with minimal assistance.You are expected to live for at least 12 more weeks.You have cancer that has spread to your brain and are experiencing symptoms.You have had a transplant using cells or organs from another person.You have a disease that can be measured using CT or MRI. Skin or subcutaneous lesions can be measured with a ruler. The disease should not have been treated with radiation before or should have shown signs of getting worse since radiation treatment.You have been diagnosed with a specific type of cancer caused by a virus called HPV16 and can provide tissue samples to confirm the diagnosis. The samples will be tested to check for the virus and a specific protein called p16INK4A.You have a significant gastrointestinal (GI) disorder that could impact your ability to participate in the study.Criteria related to pregnancy and fertility.You have an autoimmune disease that needs treatment with medication in the last two years.You received radiation therapy less than 2 weeks before starting the study drug.You must be at least 18 years old.Your blood platelet count is at least 100,000 per microliter.You have had alcohol or drug abuse issues in the past year.You have any health condition or situation that could interfere with the study or make it difficult to get accurate results.
- Group 1: CUE-101 dose escalation and expansion
- Group 2: Pembrolizumab and CUE-101
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
How many participants are actively involved in this clinical trial?
"To successfully launch the trial, Cue Biopharma needs to recruit 85 patients who meet all of the study's inclusion criteria. The sponsor will be running this clinical trial from two locations - Gabrail Cancer Center in Canton, Ohio and Affiliated Oncologists, LLC in Chicago, Illinois."
What indications does CUE-101 typically address?
"CUE-101 has been clinically validated as an effective treatment for malignant neoplasms and can also prove useful in treating conditions such as unresectable melanoma, high microsatellite instability and chemotherapy resistance."
Does CUE-101 present any risks for patients?
"Prior clinical data is sparse with respect to CUE-101's safety considerations, so this drug received a score of 1."
Are there any vacancies in this research endeavor for potential participants?
"Affirmative. Clinicaltrials.gov is host to the data that confirms this study's open recruitment, which began on July 30th 2019 and was recently revised on November 15th 2022. Seventeen sites are needed in order to enrol 85 volunteers for the trial."
How many venues are there conducting this trial?
"This clinical research trial is operating in 17 centres, such as the Gabrail Cancer Center located in Canton, Affiliated Oncologists LLC in Chicago and Barbara Karmanos Cancer Centre/Wayne State University School of Medicine based in Detroit."
Could you provide a summary of the experiments conducted with CUE-101 to date?
"CUE-101 was initially researched at City of Hope in 2010, with 249 clinical studies concluding since then. Presently, there are 963 trials actively recruiting participants; many of them taking place near Canton, Ohio."
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