Actively Recruiting
Study of TPEx chemotherapy followed by maintenance with Avelumab and Cetuximab in first-line recurrent or metastatic squamous cell carcinoma of the head and neck
Led by Groupe Oncologie Radiotherapie Tete et Cou · Updated on 2025-01-15
70
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a treatment approach for adults with advanced mouth and throat squamous cell carcinoma that has returned or spread. This Phase II trial aims to improve life expectancy by adding the drug avelumab to the standard TPEx chemotherapy treatment, which includes docetaxel, platinum-based drugs (cisplatin or carboplatin), and cetuximab. Participants must have tumors showing PD-L1 protein expression and meet specific health and laboratory criteria to join the study. The treatment involves two phases. In the first phase, participants receive standard chemotherapy combined with immunotherapy: docetaxel, cisplatin or carboplatin, plus cetuximab. The second phase is a maintenance treatment with cetuximab and avelumab, given every two weeks at specified doses until disease progression, unacceptable side effects, or, if complete response lasts over a year, according to investigator choice. Throughout the study, participants undergo assessments including imaging scans to measure tumor response and lab tests to monitor health and side effects. Researchers track overall survival at 1, 2, and 3 years as the main outcome. Participants must agree to contraceptive use if applicable, and safety is monitored continuously. The trial includes adults aged 18 to under 75 years with performance status allowing treatment.
CONDITIONS
Official Title
Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to under 75 years
- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx, or larynx not suitable for curative local therapy
- Squamous cell carcinoma of unknown primary if HPV positive
- PD-L1 protein expression with Combined Positive Score of 1 or higher
- Eastern Cooperative Oncology Group performance status 0 or 1
- No contraindications to TPEx chemotherapy and immunotherapy drugs (docetaxel, cisplatin or carboplatin, cetuximab, avelumab)
- Documentation of p16 status for oropharyngeal tumors
- Measurable disease by CT or MRI per RECIST 1.1 criteria
- Prior curative radiotherapy completed at least 4 weeks before TPEx if given without systemic treatment; prior palliative radiotherapy completed at least 2 weeks before TPEx
- Screening lab values within 14 days meeting specified blood counts and organ function criteria
- Normalized and maintained calcium levels
- Recovery to baseline or grade 1 or less from prior treatment adverse events unless stable or non-significant
- Negative pregnancy test within 72 hours before eligibility check for women of childbearing potential
- Agreement to use effective contraception from consent until 7 months post-treatment for women and 4 months for men
You will not qualify if you...
- Prior systemic chemotherapy for head and neck cancer within 6 months except as part of multimodal treatment completed earlier
- Carcinomas of the nasopharynx, HPV negative unknown primary, salivary gland, or non-squamous histologies
- Any serious or uncontrolled medical disorder increasing risk or interfering with study participation
- Active malignancy within 3 years except certain locally curable cancers
- Active autoimmune disease except stabilized type I diabetes, residual hypothyroidism, psoriasis not needing systemic treatment, or similar conditions
- Systemic corticosteroids over 10 mg prednisone daily or immunosuppressives within 14 days prior to eligibility
- Prior treatment with anti-PD1, anti-PD-L1, or other checkpoint inhibitors
- Anti-EGFR treatment less than 6 months before eligibility
- Known HIV, AIDS, active hepatitis B or C infection
- Use of live virus or bacteria vaccines within 4 weeks before eligibility except inactivated flu vaccine
- History of severe hypersensitivity to human monoclonal antibodies
- Severe psychiatric conditions limiting compliance
- Recent serious systemic infection requiring IV antibiotics
- History of organ transplant
- Hemorrhagic tumor if receiving carboplatin
- Use of phenytoin or fosphenytoin during study
- Allergy to red meat or tick bites or positive IgE antibodies against cetuximab
- Interstitial lung disease
- Uncontrolled or symptomatic cardiac disease
- Legal or guardianship restrictions preventing participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
Research Team
C
Caroline EVEN, MD
A
Adeline PECHERY
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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