Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckPhase 2TATIANANCT06640725
Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N
A Phase 2 study testing Avelumab administration at 10mg/kg and Cetuximab (Erbitux) in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial summary
The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment. All participants in this research will receive the same treatment which will take place in two phases: 1st phase chemotherapy + immunotherapy… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Avelumab administration at 10mg/kg and Cetuximab (Erbitux)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 2 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women ≥ 18 years and \< 75 years.
- Histologically confirmed recurrent and/or metastatic SCCHN (oral cavity, pharynx, larynx), not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy); squamous cell carcinoma of unknown primary if HPV positive.
- Detection of PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) SCCHN tissue samples determined by Combined Positive Score (CPS) ≥1 using local IHC assay.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Patients without contra indication to TPEx (either with cisplatin or carboplatin), to docetaxel, cetuximab and to immunotherapy (avelumab).Investigators must refer to the last updated version of Summary of product Characteristics (SPC) of the products.
- Documentation of p16 status as surrogate of human papillomavirus (HPV) status of tumor for SCC of the oropharynx.
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- Measurable disease by CT or MRI per RECIST 1.1 criteria.
- In case of radiotherapy given without systemic treatment, prior curative radiation therapy must have been completed at least 4 weeks before TPEx administration and/or prior palliative radiotherapy must have been completed at least 2 weeks before TPEx administration.
- Screening laboratory values must meet the following criteria (using NCI-CTCAE v5) and should be obtained within 14 days prior to eligibility check:
- WBC \> 2000/μL
- Polynuclear neutrophils \>1.5 x 109/L
- Platelets \> 100 x 109/L
- Hemoglobin \> 9.0 g/mL
- ALAT/ASAT\< 3.0 x ULN in the absence of liver metastases or \< 5x ULN in the presence of liver metastases
- Bilirubin \< 1.5 x ULN (except Gilbert Syndrome: \< 3.0 mg/dL)
- Creatinine clearance \> 60 mL/min (measured or calculated by preferably Cockcroft and Gault formula) for cisplatin administration and creatinine clearance between ≥ 40 mL/min and ≤ 60 mL/min (measured or calculated by preferably Cockcroft and Gault formula) for carboplatin administration.
- Calcium levels must be normalized and maintained within normal limits for study entry. Medical management of calcium levels is permitted. Note: Normal calcium levels may be based on ionized calcium or adjusted for albumin.
- Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant by the Investigator and/or stable on supportive therapy.
- Women of childbearing potential must have a negative serum or urine pregnancy test at the eligibility check. The pregnancy test must be done within 72 hours before eligibility check.
- Both men and women (of childbearing potential) who are sexually active must agree to use highly effective contraceptive method(s) from ICF signature to at least 7 months post-treatment for women and 4 months post-treatment for men.
Who cannot join
- 1.Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry.
- 2.Histologically confirmed recurrent or metastatic carcinomas of the nasopharynx, squamous cell carcinoma of unknown HPV negative primary, or salivary gland or non-squamous histologies (e.g., mucosal melanoma) are not allowed.
- 3.Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- 4.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- 5.Subjects with active, known or suspected autoimmune disease. Subjects with stabilized type I diabetes mellitus under treatment, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- 6.Subjects with a condition requiring systemic chronic administration of corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of eligibility check. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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- 7.Patients having received prior therapy with anti-PD1, anti-PD-L1(or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- 8.Prior anti-EGFR treatment received less than 6 months before eligibility check.
- 9.Patients with known positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- 10.Patients with known positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
- 11.Use of non-oncology vaccines containing live virus or bacteria for prevention of infectious diseases within 4 weeks prior to eligibility check. The use of the inactivated seasonal influenza vaccine is allowed.
- 12.History of severe hypersensitivity reaction to any human monoclonal antibody.
- 13.Severe concurrent psychiatric conditions that would limit compliance with study requirements.
- 14.Serious systemic infection requiring hospital treatment with intravenous antibiotics within 14 days prior eligibility check.
- 15.History of organ transplant. 16.Patients presenting hemorrhagic tumor, only if carboplatin is administrated. 17.Concomitant phenytoin and fosphenytoin medication during the study treatment period.
- 18.History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose).
- 19.Interstitial lung disease. 20. History of uncontrolled or symptomatic cardiac disease. 21. Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Kadouci Cherifa BRIHMOUCHE, 03 83 59 85 51 ext. +33, c.kadouci@nancy.unicancer.fr
Camille JAUD
About this study
Official title: A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)
The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment.
All participants in this research will receive the same treatment which will take place in two phases:
- 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab)
- 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.
- Being tested
- Avelumab administration at 10mg/kg, Cetuximab (Erbitux)
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelumab administration at 10mg/kgDrug
Maintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice)
Avelumab 10 mg/kg every 2 weeks (±3 days)
Cetuximab (Erbitux)Drug
Maintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice)
Cetuximab 500 mg/m² every 2 weeks (±3 days) (according to current recommendations [35])
| Study group | Role | What they receive |
|---|---|---|
| TPEx-Avelumab-Cetuximab | Experimental | Induction (TPEx regimen: up to 4 cycles Q3W) Cisplatin 75 mg/m² or Carboplatin AUC 5 every 3 weeks (±2 days). Docetaxel 75 mg/m² every 3 weeks (±2 days). Cetuximab with a loading dose of 400mg/m² at C1D1 and after 250mg/m² every week (±2 days).
Cetuximab 500 mg/m² every 2 weeks (±3 days) (according to current recommendations [35]) Avelumab 10 mg/kg every 2 weeks (±3 days) Receives: Drug: Avelumab administration at 10mg/kg; Drug: Cetuximab (Erbitux) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival (OS) defined as the time from the inclusion in the study to death due to any cause or the last follow-up contact for patients who are alive.
Measured: 1, 2and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Jan 2025
- Primary completion2 Oct 2027 (estimated)
- Study completion2 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640725
- Sponsor's protocol ID
- GORTEC 2024-01
- Other IDs
- 2023-510559-41-00, 2023
- Acronym
- TATIANA
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD contains personal data
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)
- ClinicalTrials.gov ID
- NCT06640725
- Acronym / sponsor ID
- TATIANA / GORTEC 2024-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Oct 2027 (estimated)
- Study completion
- 2 Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment.
All participants in this research will receive the same treatment which will take place in two phases:
- 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab)
- 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPEx-Avelumab-Cetuximab | Experimental | Drug: Avelumab administration at 10mg/kg, Drug: Cetuximab (Erbitux)Induction (TPEx regimen: up to 4 cycles Q3W) Cisplatin 75 mg/m² or Carboplatin AUC 5 every 3 weeks (±2 days). Docetaxel 75 mg/m² every 3 weeks (±2 days). Cetuximab with a loading dose of 400mg/m² at C1D1 and after 250mg/m² every week (±2 days). Cetuximab 500 mg/m² every 2 weeks (±3 days) (according to current recommendations [35]) Avelumab 10 mg/kg every 2 weeks (±3 days) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult men and women ≥ 18 years and \< 75 years.
- Histologically confirmed recurrent and/or metastatic SCCHN (oral cavity, pharynx, larynx), not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy); squamous cell carcinoma of unknown primary if HPV positive.
- Detection of PD-L1 protein expression in formalin-fixed, paraffin-embedded (FFPE) SCCHN tissue samples determined by Combined Positive Score (CPS) ≥1 using local IHC assay.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Patients without contra indication to TPEx (either with cisplatin or carboplatin), to docetaxel, cetuximab and to immunotherapy (avelumab).Investigators must refer to the last updated version of Summary of product Characteristics (SPC) of the products.
Key exclusion criteria (17 listed)
- 1.Prior systemic chemotherapy for the head and neck carcinoma, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry.
- 2.Histologically confirmed recurrent or metastatic carcinomas of the nasopharynx, squamous cell carcinoma of unknown HPV negative primary, or salivary gland or non-squamous histologies (e.g., mucosal melanoma) are not allowed.
- 3.Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- 4.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- 5.Subjects with active, known or suspected autoimmune disease. Subjects with stabilized type I diabetes mellitus under treatment, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelumab administration at 10mg/kgMaintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice) Avelumab 10 mg/kg every 2 weeks (±3 days) | Drug | TPEx-Avelumab-Cetuximab |
| Cetuximab (Erbitux)Maintenance (until progression, unacceptable toxicity or if CR \> 1 year, as per investigator choice) Cetuximab 500 mg/m² every 2 weeks (±3 days) (according to current recommendations [35]) | Drug | TPEx-Avelumab-Cetuximab |
Primary outcome
Overall Survival
Time frame: 1, 2and 3 years
Overall survival (OS) defined as the time from the inclusion in the study to death due to any cause or the last follow-up contact for patients who are alive.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No. IPD contains personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab administration at 10mg/kg and Cetuximab (Erbitux) in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline EVEN, MD (0142116597 ext. +33, caroline.even@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1, 2and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.