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CUE-101 for Oropharyngeal Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University Medical Center, Palo Alto, CAOropharyngeal Squamous Cell Carcinoma+2 MoreCUE-101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
  • Human Papillomavirus-Related Carcinoma
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
RM-1995
1
CYAD-101
1
IMPRINT

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 36 months

36 months
Dose Limiting Toxicity
Overall response rate (ORR)
Serum PK parameters for CUE-101

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
RM-1995
1
CYAD-101
1
IMPRINT

Side Effects for

Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Alopecia
38%Headache
33%Nausea
29%Dyspnea
29%Cough
29%Hypothyroidism
29%Pain
24%Rash maculo-papular
24%Constipation
19%Diarrhea
19%Pain in extremity
19%Abdominal pain
19%Infusion related reaction
19%Bloating
19%Dyspepsia
19%Anorexia
14%Allergic rhinitis
14%Dehydration
14%Anemia
14%Sinusitis
14%Nasal congestion
14%Hyperglycemia
14%Edema limbs
14%Hypokalemia
10%Neutrophil count decreased
10%Hyperthyroidism
10%Fall
10%Restlessness
10%Pneumonitis
10%Pruritus
10%Lymphedema
10%Hoarseness
10%Dry mouth
10%Myalgia
10%Hot flashes
10%Thromboembolic event
10%Mucositis oral
10%Skin infection
10%Vomiting
10%Localized edema
10%Alanine aminotransferase increased
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Dizziness
10%Flushing
5%Urinary tract pain
5%Atrial flutter
5%Hepatobiliary disorders - Other, specify
5%Bruising
5%Hypophosphatemia
5%Urinary urgency
5%Postnasal drip
5%Sneezing
5%Skin hyperpigmentation
5%Hypertension
5%Hypoglycemia
5%Mucosal infection
5%Alkaline phosphatase increased
5%Respiratory failure
5%Fever
5%Malaise
5%Nail infection
5%Upper respiratory infection
5%Urinary incontinence
5%Epistaxis
5%Laryngeal hemorrhage
5%Sore throat
5%Urinary frequency
5%Hepatic failure
5%Lung infection
5%Dysgeusia
5%Recurrent laryngeal nerve palsy
5%Syncope
5%Insomnia
5%Hypoxia
5%Periorbital edema
5%Hypotension
5%Metabolism and nutrition disorders - Other, specify
5%Infections and infestations - Other, specify
5%Lymph gland infection
5%Hyponatremia
5%Gastrointestinal disorders - Other
5%Urinary tract infection
5%Blood bilirubin increased
5%Creatinine increased
5%Platelet count decreased
5%Bone pain
5%Conjunctivitis
5%Eye disorders - Other, specify
5%Flashing lights
5%Non-cardiac chest pain
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
5%Nail loss
5%Nail ridging
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03018080) in the Arm A (Phased Pembrolizumab Regimen) ARM group. Side effects include: Fatigue with 71%, Peripheral sensory neuropathy with 43%, Alopecia with 38%, Headache with 38%, Nausea with 33%.

Trial Design

1 Treatment Group

CUE-101 dose escalation and expansion
1 of 1

Experimental Treatment

85 Total Participants · 1 Treatment Group

Primary Treatment: CUE-101 · No Placebo Group · Phase 1

CUE-101 dose escalation and expansion
Drug
Experimental Group · 1 Intervention: CUE-101 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Cue BiopharmaLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,710 Previous Clinical Trials
4,967,271 Total Patients Enrolled
Kenneth Pienta, MDStudy DirectorCue Biopharma
5 Previous Clinical Trials
62 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
Results from medical tests show certain abnormalities or conditions.
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 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 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 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 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 must be at least 18 years old.
Your blood platelet count is at least 100,000 per microliter.
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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