TG4050 for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Transgene
Must not be taking: Anti-cancer vaccines, Anti-PD1
Disqualifiers: HIV/AIDS, Hepatitis B/C, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on another investigational agent, you may need to stop that treatment.
How is the drug TG4050 different from other treatments for head and neck cancer?
Research Team
Eligibility Criteria
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.Inclusion Criteria
I am 18 years old or older.
I am fully active or restricted in physically strenuous activity but can do light work.
My blood, liver, and kidney functions are all within normal ranges.
See 3 more
Exclusion Criteria
I do not have any uncontrolled illnesses.
I have previously received immunotherapy for cancer.
My cancer is not from the skin, salivary gland, or sinuses and is not squamous cell carcinoma.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive TG4050 treatment either at completion of primary treatment or at the time of recurrence
Up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Treatment Details
Interventions
- TG4050 (Cancer Vaccine)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
Transgene
Lead Sponsor
Trials
23
Recruited
1,700+
Findings from Research
Cisplatin combined with 5-fluorouracil (5-FU) remains the standard treatment for head and neck cancer (HNC), but new strategies are being explored to enhance its effectiveness, including using oral fluoropyrimidines and alternative cisplatin formulations.
Cetuximab, an anti-EGFR monoclonal antibody, has shown a consistent response rate of 10-13% in patients with platinum-refractory recurrent or metastatic HNC, and a recent Phase III trial indicated that combining cetuximab with cisplatin improves response rates compared to cisplatin alone.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Recent advances in head and neck cancer therapy: the role of new cytotoxic and molecular-targeted agents.Caponigro, F., Milano, A., Basile, M., et al.[2018]
The FDA has approved the first immunotherapies, nivolumab and pembrolizumab, for treating recurrent squamous cell carcinoma of the head and neck (HNSCC), marking a significant advancement in treatment options for patients who have not responded to traditional platinum-based chemotherapy.
These approvals represent the first new therapies for HNSCC since 2006 and include guidelines for patient selection and management, aiming to improve outcomes and standardize the use of immunotherapies in clinical practice.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC).Cohen, EEW., Bell, RB., Bifulco, CB., et al.[2023]
In a Phase III study involving 219 Chinese patients with advanced squamous cell carcinoma of the head and neck, the combination of dose-modified docetaxel, cisplatin, and 5-fluorouracil (TPF) showed a higher overall response rate (76.3%) compared to the PF regimen (52.9%), indicating increased anti-tumor activity.
However, the addition of docetaxel did not significantly improve progression-free survival (PFS), with median PFS being 400 days for TPF and 342 days for PF, suggesting that while TPF may enhance response rates, it does not extend the time before disease progression.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Neoadjuvant dose-modified docetaxel in squamous cell carcinoma of the head and neck: A phase 3 study.Sun, Y., Guo, W., Bai, Y., et al.[2020]
References
Recent advances in head and neck cancer therapy: the role of new cytotoxic and molecular-targeted agents. [2018]
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC). [2023]
Neoadjuvant dose-modified docetaxel in squamous cell carcinoma of the head and neck: A phase 3 study. [2020]
Current recommendations for systemic therapy of recurrent and/or metastatic head and neck squamous cell cancer. [2019]
Taxotere, cisplatin, fluorouracil, and leucovorin (TPFL)as induction chemotherapy for locally advanced squamous cell carcinoma of the head and neck. [2018]