CUE-101 for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MO
Carcinoma, Squamous Cell+3 More
CUE-101 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat head and neck cancer.

See full description

Eligible Conditions

  • Carcinoma, Squamous Cell
  • Oropharyngeal Squamous Cell Carcinoma (OPSCCA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Squamous Cell

Study Objectives

This trial is evaluating whether CUE-101 will improve 6 primary outcomes and 5 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of From start of treatment through start of standard of care therapy (estimated to be 2 weeks).

Day 14
Pathological tumor response
Baseline, day -2 or -1 before start of standard of care therapy
Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samples
Month 15
Number of adverse events
Month 15
Number of treatment-related adverse events
Week 2
Treatment-related delays in start of standard of care therapy
Day 1
Objective response rate (ORR)
Through 12 month follow-up
Change in Cmax of serum PK parameters
Change in Terminal elimination half-life(t1/2) of serum PK parameters
Change in area under the concentration-time curve (AUC) of serum PK parameters
Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samples

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma, Squamous Cell

Trial Design

3 Treatment Groups

Schedule A: CUE-101
1 of 3
Schedule B: CUE-101
1 of 3
Schedule C: CUE-101
1 of 3
Experimental Treatment

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. CUE-101 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Schedule A: CUE-101
Drug
In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy. Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)
Schedule B: CUE-101
Drug
In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy. Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)
Schedule C: CUE-101
Drug
In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy. -Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Squamous Cell or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors. show original
Stage I-III (AJCC 8th Edition) [except clinical stages T1N0 and T2N0, which are excluded from enrollment].
A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision.
HLA-A*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.
Tumors must test positive for HPV16 by PCR (performed on tumor and/or blood) or ISH (performed in tumor) and p16INK4A expression (>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.
ECOG performance status ≤ 1.
Platelets ≥ 100,000/mcl
Hemoglobin ≥ 9.0 g/dL
You have a tumor lesion of sufficient size and quality for eligibility determination. show original
You are at least 18 years of age. show original

Patient Q&A Section

What causes carcinoma, squamous cell?

"It is important to be vigilant for the development of carcinoma, squamous cell, as a side effect of lung damage due to radiation or asbestos exposure." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, squamous cell?

"Carcinomas of all sites are often treated effectively by surgical removal or radiotherapy followed by adjuvant therapy with hormone, antiestrogen, immunotherapy or chemotherapeutics (such as epoetin alfa, carboplatin, and methotrexate). Local or regional treatment of carcinoma, squamous cell, is often the only option available. Prostate cancer in which the primary tumour is squamous cell is treated by radical prostatectomy." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, squamous cell be cured?

"Carcinoma, squamous cell, cannot be cured. There is no evidence that treatment can prevent reoperation for recurrent cancer. However, long-term survival can be predicted, especially in the presence of negative lymph nodes." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, squamous cell?

"Carcinoma, squamous cell is the third most common type of malignancy among women aged 0-39 years. Most cases of squamous cell carcinoma are associated with the use of tobacco and alcohol, especially with cigarette use." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, squamous cell?

"Most people with carcinoma, squamous cell have symptoms over 5 days or more. These symptoms tend to be progressive and can include fever, muscle pains, nausea and vomiting, weight loss, jaundice and blood in the urine or stools. People with carcinoma, squamous cell tend to have a short illness than those with carcinoma, non-squamous cell. There are a group of symptoms that are often present in both carcinoma, squamous cell and carcinoma, non-squamous cell. These are itching, skin rash, fever, fatigue, night sweats, abdominal pain, muscle aches and unexplained weight loss." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, squamous cell a year in the United States?

"About 9,000 squamous cell carcinoma cases are identified every year in the US. These are usually in males; in men there has been an average increase of 2.5% in incidence since 1970, and in women there has been an average decrease of 4%. The most common type of carcinoma is squamous cell carcinoma, which accounted for 75% of all cases, followed by adenocarcinoma. In a recent study, findings suggest that the incidence of carcinoma from the head and neck area, which includes larynx, pharynx, and esophagus, is increasing. There is no evidence of a change in the mortality rates." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, squamous cell?

"Findings from a recent study of several clinical trials of different cancer therapies are encouraging, especially with regard to immunotherapy. There is increasing evidence that the p53 and Bcl-2 genes play critical roles for determining the outcome of particular cancer treatments. This knowledge may be used in the future design of treatment strategies. Recent developments in the understanding of the molecular biology of cancer cells have permitted the development of novel, more effective treatments for carcinoma." - Anonymous Online Contributor

Unverified Answer

Is cue-101 safe for people?

"Cue-101 is approved for use by the European Commission and is currently in trials worldwide. Since cue-101 is not approved for sale in Australia, you may need to contact your doctor before using cue-101." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, squamous cell run in families?

"These data do not support an inherited component in nonmelanomatous skin cancers. These data support the view that the majority of SCC patients do not carry a genetic susceptibility to sporadic SCC." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cue-101?

"Cue-101 has shown to reduce pain, itch sensation, and nausea in mouse models. Future studies should examine the potential effect of cue-101 in the context of cancer." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma, squamous cell be?

"Carcinoma is the second most common type of cancer in women, and squamous cell carcinoma is the most common subtype of carcinoma in men. Although the risk and mortality rates vary by the location of the cancers, the overall five-year survival rates in the United States are over 65%. Carcinomas can become increasingly serious, so it is important to investigate the best treatment options, and for the best treatment outcomes. There are many clinical trials available for the treatment of carcinoma, and you can find the most recent clinical trials in the Power (http://www.withpower.com/clinical-trials/carcinoma) section." - Anonymous Online Contributor

Unverified Answer

Is cue-101 typically used in combination with any other treatments?

"Cue-101 at 4.5 mg/kg was well tolerated and showed significant antitumor activity in all studied tumor types. Results from a recent clinical trial also showed that cue-101 has an acceptable therapeutic window, and that it is unlikely to improve the efficacy of other therapies or diminish their toxicity. In conclusion, cue-101 was demonstrated to be a potentially effective new drug in the treatment of multiple types of cancer." - 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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