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CAR T-cell Therapy
CUE-101 + Keytruda for Head and Neck Squamous Cell Carcinoma
Phase 1
Waitlist Available
Research Sponsored by Cue Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma who've had prior systemic therapy. They must have measurable disease, be HLA A*0201 genotype positive, and able to consent to study procedures. Exclusions include HIV/AIDS, hepatitis B/C, other cancers within 2 years, recent major surgery or trauma, significant heart disease, active infections requiring IV treatment, mental incapacity to consent.Check my eligibility
What is being tested?
The trial is testing CUE-101 alone as a second-line treatment or in combination with Pembrolizumab (KEYTRUDA®) as a first-line treatment. It's an open-label phase 1 study focusing on safety and effectiveness against HPV16+ head and neck cancer.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to KEYTRUDA®, such as inflammation of organs; infusion-related reactions; fatigue; digestive issues; blood disorders; increased risk of infection. Specific side effects from CUE-101 are not detailed but could overlap with those known from similar treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity
Serum PK parameters for CUE-101
Secondary outcome measures
Overall response rate (ORR)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab and CUE-101Experimental Treatment2 Interventions
Part C&D: CUE-101 Dose Escalation in Combination with KEYTRUDA® (pembrolizumab) for injection, for IV use 200 mg Q3W (Part C). Expansion of pembrolizumab plus CUE-101 at the combination RP2D (Part D)
Group II: CUE-101 dose escalation and expansionExperimental Treatment1 Intervention
Part A&B: CUE-101 Monotherapy IV infusion Q3W Dose Escalation (Part A) and Expansion (Part B)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KEYTRUDA®
2018
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Cue BiopharmaLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,633 Total Patients Enrolled
Matteo Levisetti, MDStudy DirectorCue Biopharma
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: CUE-101 dose escalation and expansion
- Group 2: Pembrolizumab and CUE-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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