Last reviewed · How we verify
NCT06640725: TATIANA
Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N
Phase 2 trial testing Avelumab administration at 10mg/kg in Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck in 70 participants. Currently enrolling.
2 October 2027
Quick facts
| Lead sponsor | Groupe Oncologie Radiotherapie Tete et Cou |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 2 January 2025 |
| Primary completion | 2 October 2027 |
| Estimated completion | 2 December 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- Avelumab administration at 10mg/kg — full drug profile →
- Cetuximab (Erbitux)
Conditions studied
- Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck — all drugs for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck →
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou — full company profile →
Who can join
Adults 18 to 74, any sex, with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06640725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Avelumab administration at 10mg/kg
Trials testing the same drug.
- NCT03135769 — Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias · Phase 2 · completed
Other Groupe Oncologie Radiotherapie Tete et Cou trials
Trials by the same sponsor.
- NCT05930938 — Study Comparing RT With Cetuximab + Xevinapant to RT With Cetuximab-placebo in Patients With Head and Neck Cancer · Phase 3 · terminated
- NCT05930951 — Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck · Phase 1 · terminated
- NCT04356170 — Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma · Phase 2 · completed
- NCT03330249 — Comparison of Two Concomitant Administration of RT With Cisplatin in Standard Infusion or Fractional Infusion · Phase 2 · completed
- NCT02268695 — Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06640725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou
- Last refreshed: 15 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06640725.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing