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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Newly diagnosed stage III or IVA squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years.
Awards & highlights
Study Summary
This trial is testing a new drug, TG4050, for safety and effectiveness in treating squamous cell carcinoma of the head and neck.
Who is the study for?
Adults with newly diagnosed stage III or IVA squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx who are in complete response after primary tumor treatment. Participants must be generally healthy with an ECOG performance status of 0 or 1 and have proper organ function. Excluded are those with other active cancers, prior cancer immunotherapies, HIV/AIDS, hepatitis infections, pregnant/nursing women, and recent involvement in other drug trials.Check my eligibility
What is being tested?
The trial is testing TG4050's safety and potential effectiveness for head and neck cancer patients. It's a phase I study where participants are randomly assigned to one of two groups to receive this experimental vaccine therapy. The study is open-label meaning both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
While specific side effects for TG4050 aren't listed here as it's a new treatment under evaluation, common side effects from similar therapies may include flu-like symptoms such as fever and chills; injection site reactions; fatigue; nausea; muscle or joint pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have been newly diagnosed with advanced cancer in my mouth or throat.
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My primary cancer is completely gone after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I/II: Disease-Free Survival
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
Secondary outcome measures
Phase I/II: Distant Metastases-Free Survival
Phase I/II: Loco-Regional Relapse-Free Survival
Phase I/II: Overall Response Rate in patients with recurrent disease
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Study treatment initiation at recurrenceExperimental Treatment1 Intervention
TG4050 treatment initiation at the time of recurrence
Group II: Arm A : Early study treatment initiationExperimental Treatment1 Intervention
TG4050 treatment initiation at completion of primary treatment
Find a Location
Who is running the clinical trial?
TransgeneLead Sponsor
22 Previous Clinical Trials
1,588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have previously received immunotherapy for cancer.My cancer is not from the skin, salivary gland, or sinuses and is not squamous cell carcinoma.My blood, liver, and kidney functions are all within normal ranges.I have tested positive for HIV/AIDS.You have taken another experimental drug within the last 30 days before starting treatment with TG4050.I have had cancer other than the one being studied in this trial.I have a history of Hepatitis B or C.I am currently receiving treatment for another cancer.I have been newly diagnosed with advanced cancer in my mouth or throat.My primary cancer is completely gone after treatment.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A : Early study treatment initiation
- Group 2: Arm B: Study treatment initiation at recurrence
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned TG4050 for public use?
"Our experts at Power gave TG4050 a rating of 1 as it is currently undergoing Phase 1 trials, which indicates there are limited data points evaluating its safety and efficacy."
Answered by AI
Could you tell me if this research project is currently welcoming volunteers?
"According to the data posted on clinicaltrials.gov, this study is actively recruiting candidates and has been since December 12th 2019 with its most recent update occurring on November 5th 2021."
Answered by AI
What is the scope of this research project in terms of participants?
"Affirmative. The details hosted on clinicaltrials.gov reveal that this medical trial, which was first advertised in December of 2019, is still seeking new enrollees. In total, 30 patients are being recruited from a single site."
Answered by AI
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