Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España
Actualizado agosto 2025
Información Pública obtenida a partir de: Clinical Trials.gov; EU Clinical Trials Register; REEC (AEMPS)
| EuCT number | NCT | STUDY-Code | TITLE | PHASE | INDICATION | STATUS | DRUGS | SITES | SPONSOR |
|---|---|---|---|---|---|---|---|---|---|
| 2024-516779-33-00 | 5784012 | TTCC-2022-01 RADIAN | Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo) RadIotherapy in LocallyAdvanced; Head and Neck Squamous Cell Carcinoma (RADIAN) | Phase 1b/II | Multi-center, open-label, non-randomized, non-comparative two-cohort study for patients with locally-advanced squamous cell carcinoma arising from the larynx, hypopharynx, oropharynx (Stage III, IVA and IVB according to 8th TNM/AJCC ed.) and oral cavity (unresectable, stage IVB according to 8th TNM/ American Joint Committee on Cancer (AJCC). Recruiting Cohort B |
RECRUITING | Dostarlimab Niraparib Radiation Therapy |
ICO Hospitalet H.U. Clínic (BCN) ICO Badalona H.U. Vall d´Hebron (BCN) C.H. Navarra (Pamplona) H. Clinico de Valencia H. 12 de Octubre |
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC) |
| 2024-514953-31-00 | 6856213 | TTCC-2022-02 ERBIOTAX | TTCC-2022-02: a Phase II, Multicenter, Randomized Study of Cetuximab Plus/ Minus Weekly Paclitaxel After Progression to First-Line Pembrolizumab Plus Platinum-5FU in Subjects with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (ERBIOTAX) | Phase II | The study aims to evaluate the efficacy of weekly cetuximab combined with paclitaxel (Arm A) or cetuximab monotherapy (Arm B) after progression to pembrolizumab plus platinum / 5-FU. The efficacy of treatment will be assessed through objective response rate (ORR). |
RECRUITING | Cetuximab Paclitaxel |
H.U. Clinico San Carlos(Madrid) ICO-Hospitalet H.U. 12 Octubre H.U. Infanta Leonor(Madrid) H.U.M. Valdecilla(Santander) H.U. Navarra C.O. Galicia H.U.Virgen Valme(Sevilla) H.U.Virgen Rocio(Sevilla) H.U. Canarias (Tenerife) C.H. Salamanca |
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC) |
| LOCALLY-ADVANCED H&N | |||||||||
| 2023-508613-17-00 | 6256588 | 221530 | A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE) | Phase III | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma. | RECRUITING | Dostarlimab Placebo |
H.U.Marques Valdecilla (Santander) C.H. Navarra C.H. Salamanca H. U. Miguel Servet (Zaragoza) H. Lucus Augusti (Lugo) H.U. Cruces (Bilbao) H. U. 12 Octubre (Madrid) H.U.La Paz (Madrid) H. Clinico San Carlos (Madrid) H.U. Jerez de la Frontera (Cadiz) ICO-Hospitalet H. Vall d Hebron(BCN) H. Cartagena |
GlaxoSmithKline |
| 2023-506294-36-00 | 6129864 | D798EC00001 | A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected LocallyAdvanced (Head and Neck Squamous Cell Carcinoma), Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC) | Phase III | The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT) | RECRUITING | Volrustomig | ICO Badalona H. Vall d Hebron(BCN) H. Clinic (BCN) H. Clinico San Carlos (Madrid) H.U.Ramon y Cajal (Madrid) H. General Valencia H. U. La Fe (Valencia) H. U. Gregorio Marañon (Madrid) H. U. Jaen |
AstraZeneca |
| 2024-520386-31-00 | 4892173 | NANORAY-312 | A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC | Phase III | This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC. | RECRUITING | JNJ-90301900 (NBTXR3) Cetuximab Radiation Therapy |
H.U.Cruces(Bilbao) C.Hospitalario Navarra H.U.M. Valdecilla(Santander) H. Clínic (BCN) H.U. 12 Octubre (Madrid) H.U. Vall d Hebron(BCN) ICO Hospitalet H.U. Lucus Augusti(Lugo) F.Jimenez Diaz(Madrid) H.Sanchinarro(Madrid) H.Regional Malaga H.U. Virgen del Rocio(Sevilla) I.Valenciano de Oncologia H.General Valencia |
Johnson & Johnson Enterprise Innovation Inc. |
| 2022-502787-20-00 | 5280314 | MK-3475-E40 | Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab in Patients With Selected Resectable Tumors in Squamous Cell Carcinoma of Head and Neck. | Phase II | This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications. | RECRUITING | IO102-IO103 Pembrolizumab |
H. Clinico Valencia H. Ramon y Cajal (Madrid) H. Quirón Dexeus (BCN) ICO-Badalona |
IO Biotech |
| RECURRENT-METASTATIC H&N | |||||||||
| 2023-510323-30-00 | 6525220 | MCLA-158-CL03 | This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma. | Phase III | Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was >1 year after the last dose of cetuximab are eligible. | RECRUITING | Petosemtamab Pembrolizumab |
3 sites Madrid 2 sites Barcelona Marbella Valencia C.H. Pamplona CUN |
Merus N.V. |
| 2023-506308-24-00 | 6082167 | XL092-305 | A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (STELLAR-305) | Phase II/III | This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease. | RECRUITING | Zanzalintinib Zanzalintinib-matched Placebo Pembrolizumab |
5 Sites Madrid 1 Site BCN ICO-Girona 1 Site Coruña 1 Site Pamplona 1 Site Sevilla 1 Site Zaragoza 1 Site Valencia |
Exelixis |
| 2024-515538-34-00 | 6295731 | INBRX106-01-201 | A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN) | Phase II/III | This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. | RECRUITING | INBRX-106 Pembrolizumab |
H.Quiron Salud Barcelona | Inhibrx Biosciences, Inc |
| 2023-503428-24-00 | 6062420 | 219885 | A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202 | Phase II | The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC). | RECRUITING | Dostarlimab Belrestotug Nelistotug GSK4381562 |
H. Ramon y Cajal (Madrid) H. 12 Octubre (Madrid) ICO-Hospitalet H.U. Jaen H. Puerta de Hierro (Madrid) C.H. Salamanca H.Miguel Servet (Zaragoza) H. Quirón-Madrid & Barcelona H. Vall d'Hebron(BCN) H.U.M.Valdecilla(Santander) H. Clinico San Carlos (Madrid) I.Valenciano de oncologia H. La Milagrosa (Madrid) |
GlaxoSmithKline |
| 2024-512671-12-00 | 4534205 | BNT113-01 | An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Treatment in Patients With Unresectable Recurrent or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 | Phase II | The purpose of this trial is to investigate the efficacy and safety of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. | RECRUITING | BNT113 Pembrolizumab |
H.U. 12 Octubre (Madrid) H. Vall d'Hebron (BCN) ICO Hospitalet C.H.U. Santiago Multiple Sites |
BioNTech SE |