Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España
Actualizado marzo 2025
Información Pública obtenida a partir de: Clinical Trials.gov; EU Clinical Trials Register; REEC (AEMPS)
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| Eudra/Eu_CT | 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 | 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 | |||||||||
| UNK | 2984410 | EORTC-1420-HNCG-ROG | Phase III Study Assessing the "Best of" Radiotherapy Compared to the "Best of" Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma | Phase III | The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC. Oropharyngeal Cancer Supraglottic Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma | RECRUITING | Intensity-Modulated Radiation Therapy (IMRT). Trans Oral Surgery (TOS) | H.U. Ramón y Cajal (Madrid) H. U. Central de Asturias H.U. Donostia (not yet recruiting) | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| UNK | 5527782 | HUDP-CyC-01/2022 | A Phase II Study of Efficacy and Safety of Induction Modified TPF (mTPF) Followed by Concurrent Chemoradiotherapy (CCRT) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LASCCHN) | Phase II | The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer. | RECRUITING | Modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy | H.U. Doctor Peset (Valencia) H. Gandia (Alicante) H. Villajoyosa (Alicante) | H.U. Doctor Peset | |||||||||
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 | 2 sites Madrid Marbella Valencia C.H. Pamplona CUN | Merus N.V. | |||||||||
| 2023-510322-32-00 | 6496178 | MCLA-158-CL02 | A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigator's Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/recurrent Head and Neck Squamous Cell Carcinoma | Phase III | A Phase 3 Study to Evaluate Petosemtamab Compared with Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients | RECRUITING | Petosemtamab Investigator's Choice | 2 sites Madrid Barcelona Valencia C.H. Pamplona CUN | Merus N.V. | |||||||||
| 2023-505606-42-00 | 6064877 | AV-299-23-301 | A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN) | Phase III | The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. | RECRUITING | Ficlatuzumab Cetuximab Placebo | H.U.Vinalopo(Alicante) H.U. La Paz ICO-Hospitalet ICO-Badalona H.Torrejon(Madrid) H.Quiron(Malaga) H.Sanchinarro H.U.Jerez Frontera(Cadiz) | AVEO Pharmaceuticals, Inc. | |||||||||
| 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 centros Madrid 1 centro BCN ICO-Girona 1Centro Coruña 1centro Pamplona 1centro Sevilla 1centro Zaragoza 1centro 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 â¥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/âMetastatic 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 | |||||||||
| 2023-508418-40-00 | 6385080 | 61186372HNC2002 | A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer (OrigAMI-4) | Phase II | The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. | RECRUITING | Amivantamab Pembrolizumab Paclitaxel Carboplatine | H.12 Octubre H. Ramon y Cajal ICO - Hospitalet H. Vall d'Hebron | Janssen Research & Development, LLC | |||||||||
| 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 Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT) | Phase II | A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (AHEAD-MERIT) | RECRUITING | BNT113 Pembrolizumab | H.U. Clínic (BCN) H.U. La Paz (Madrid) H.U. Puerta de Hierro (Madrid) C.H. Jaén C.U.N ICO Girona H. Regional de Málaga H.U. Son Espases (P.Mallorca) Start_F.J.Díaz (Madrid) H.La Fe (Valencia) H.Miguel Servet (Zaragoza) | BioNTech SE | |||||||||
| 2023-508561-33-00 | 4183166 | TG4050.02 | A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy. | Phase I/II | 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). | RECRUITING | TG4050 | ICO-Hospitalet H. Clinico San Carlos (Madrid) H. Vall d'Hebron (BCN) H.U.La Paz (Madrid) H.U. Santiago de Compostela H.Regional de Málaga | Transgene | |||||||||
| 2022-503055-26-00 | 6016920 | VB-C-03 | A Phase 1/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 and Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head-Neck Squamous Cell Carcinoma. | Phase I/IIA | The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab | RECRUITING | VB10.16 Pembrolizumab | ICO-Hospitalet H. del Mar (BCN) H. Virgen de las Nieves (Granada) M.D.Anderson (Madrid) | Nykode Therapeutics ASA | |||||||||
| 2023-510307-22-00 | 4958239 | 1463-0001 | An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) | Phase I | Participants can stay in the study up to 3 years (Part 1) or 2 years (Part 2) if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment. | RECRUITING | BI 765179 Ezabenlimab Pembrolizumab | H.Clinico San Carlos (Madrid) H. Vall d Hebron (BCN) ICO-Badalona CUN | Boehringer Ingelheim | |||||||||
| 2024-511477-29-00 | 6648096 | IRSSP-001 | Phase Ib/II Study to Investigate the Safety and Efficacy of Afatinib When Administered As Therapy in Fanconi Anemia Patients with Unresectable and / or Metastatic Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx or Hypopharynx or Larynx. | Phase Ib/II | The main hypothesis, based on preclinical evidence, is that treatment with afatinib, an epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), could be an effective treatment option to control cancer for patients with FA - HNSCC. | RECRUITING | Afatinib | H.U. Sant Pau (Barcelona) | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | |||||||||
Tumores Sólidos con Cohorte de Cáncer de Cabeza y Cuello | ||||||||||||||||||
| 2024-514461-19-00 | 4868877 | MCLA-129-CL01 | Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors (H&N..) | Phase I/II | A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 as monotherapy | RECRUITING | MCLA-129 Osimertinib Chemotherapy | H. U. Vall d'Hebron (BCN) H. Sant Pau (BCN) H. Gregorio Marañón (Madrid) H. 12 Octubre (Madrid) H. La Fé (Valencia) I.Valenciano Oncologia (IVO) C.U.N Start_F.J.Diaz(Madrid) Start_Sanchinarro(Madrid) Next_Oncology H.M. Delfos (BCN) | Merus N.V. | |||||||||
| 2024-513627-16-01 | 3526835 | MCLA-158-CL01 | Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors. | Phase I/ II | This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the RP2D of MCLA-158 single agent in patients with mCRC. | RECRUITING | MCLA-158 MCLA-158 + Pembrolizumab MCLA-158 + FOLFIRI MCLA-158 + FOLFOX | H. 12 de Octubre (Madrid) C. H. Navarra I. Valenciano Oncologia (IVO) H. Vall d'Hebron (BCN) CUN | Merus N.V. | |||||||||
| 2023-503651-10-00 | 4895709 | CA052-002 | A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors. | Phase I/ II | The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. | RECRUITING | BMS-986340 BMS-936558-01 Docetaxel | ICO-Badalona H. Vall d'Hebron (BCN) H. V. de la Victoria (Málaga) H. U. 12 Octubre (Madrid) Start_Sanchinarro(Madrid) Start_F.J.Diaz(Madrid) C.U.N | Bristol-Myers Squibb | |||||||||
| 2023-505334-10-01 | 5592626 | CP-START-001 | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001) | Phase I/II | This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. Advanced Solid Tumors: Papillomavirus Infection Epstein-Barr Virus Infections | RECRUITING | STAR0602 | H.Vall d'Hebron Start-Fjimenez Diaz | Marengo Therapeutics, Inc. | |||||||||
| UNK | 4585750 | KEYNOTE-D79 | A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation. (PYNNACLE) | Phase I/II | This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation. | RECRUITING | Rezatapopt Pembrolizumab | H. U. Vall d'Hebron (BCN) Start_F.J.Diaz(Madrid) Start_Sanchinarro(Madrid) Next_Oncology (Quiron-BCN) H. Clinico de Valencia | PMV Pharmaceuticals, Inc | |||||||||
| 2024-510655-36-00 | 4180371 | BT5528-100 | Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression. | Phase I/ II | This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2 | RECRUITING | BT5528 Nivolumab | ICO Hospitalet H. Vall d'Hebron (BCN) H. 12 Octubre (Madrid) Start_Sanchinarro (Madrid) Start_F.J.Diaz (Madrid) | BicycleTx Limited | |||||||||
| 2023-506228-10-00 | 6305247 | CLIN-01194-450 | An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours | Phase I/IIA | The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally). | RECRUITING | IPN01194 IPN01194 | H. Vall d'Hebron (BCN) Start_F.J.Diaz (Madrid) M.D.Anderson (Madrid) | Ipsen | |||||||||
| 2023-506539-14-00 | 5983432 | BL-B01D1-LUNG-101 | Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors | Phase I | The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Included Nasopharyngeal Cancer cohort. | RECRUITING | BL-B01D1 | Star_Sanchinarro (Madrid) Start_F.J. Díaz (Madrid) | SystImmune Inc. | |||||||||
| 2022-502381-25-01 | 5544929 | CKFA115A12101 | A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers | Phase I | The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose. Included cohort: Cutaneous Melanoma Nasopharyngeal Carcinoma Squamous Cell Carcinoma of Head and Neck | RECRUITING | KFA115 Pembrolizumab | H. Vall d'Hebron (BCN) | Novartis Pharmaceuticals | |||||||||
| 2023-507641-29-00 | 6172478 | U31402-277 | HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors | Phase I | This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced or metastatic solid tumors who have been previously treated with ≥1 prior line of systemic anticancer therapy. | RECRUITING | HER3-DXd | H.Ramón y Cajal H. 12 Octubre H. G.Marañon H.Regional Malaga H.U. Virgen Macarena(Sevilla) H.Clinic de Valencia H. Clinic BCN H.U.Sant Pau H.U.Vall Hebron | Daiichi Sankyo | |||||||||
| 2023-504807-94-00 | 5768139 | STX-478-101 | First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors | Phase I | Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with P13Ka mutations. | RECRUITING | STX-478 Fulvestrant Ribociclib Palbociclib | Madrid Barcelona | Scorpion Therapeutics, Inc. | |||||||||
| 2023-505346-26-01 | 5683418 | TOS-358-001 | A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid Tumors | Phase I | The main questions it aims to answer are: -what is the maximum tolerated dose and recommended dose for phase 2? -how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? | RECRUITING | TOS-358 | Madrid Barcelona Valencia Pamplona | Totus Medicines | |||||||||
| 2023-510061-10-00 | 5176483 | XL092-002 | Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002). | Phase I | A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors. | RECRUITING | Zanzalintinib; Nivolumab; Ipilimumab; Nivolumab + Relatlimab | H. 12 de Octubre (Madrid) H.Virgen del Rocio (Sevilla) H. La Fe H. Cliníc (BCN) C.U.N H. Clinico Valencia H. C. San Carlos (Madrid) F.J. Diaz Madrid H. Ramon y Cajal(Madrid) H. Sant Pau (BCN) ICO-Hospitalet H. Vall d'Hebron(BCN) M.D. Anderson (Madrid) H.U. Badajoz | Exelixis | |||||||||
| 2022-501570-18-00 | 5647122 | D9350C00001 | A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors. | Phase I | The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents. | RECRUITING | AZD9592 Osimertinib 5-Fluorouracil (5-FU) Leucovorin Bevacizumab | H. Vall d'Hebron(BCN) H. Virgen del Rocio (Sevilla) Start_F J Diaz (Madrid) | Astra Zeneca | |||||||||
| 2023-506604-18-00 | 5208762 | SGNPDL1V-001 | A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors. | Phase I | This study will have three parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers. | RECRUITING | PF-08046054 pembrolizumab | ICO Hospitalet H. Vall d'Hebron(BCN) Start_Sanchinarro (Madrid) Next-Oncology | Seagen Inc. | |||||||||
| 2023-508469-34-00 | 4389632 | SGNB6A-001 | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors. | Phase I | The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors. | RECRUITING | Sigvotatug vedotin Pembrolizumab Cisplatin Carboplatin | H.U. Vall d´Hebron (BCN) Start_Sanchinarro (Madrid) H.M.Valdecilla (Santander) H.M. Nou Delfos (BCN) Next_Quiron (BCN) H. U. de Elche H. U. Ramon y Cajal (Madrid) H.U de Jerez (Cadiz) | Seagen Inc. | |||||||||
| 2024-511286-11-00 | 5238883 | HFB-200301-01 | A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors | Phase I | The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancer. | RECRUITING | HFB200301 Tislelizumab | H. Vall d'Hebron(BCN) H. 12 Octubre (Madrid) H. Clinico Valencia | HiFiBiO Therapeutics | |||||||||
| 2023-509867-26-00 | 6238479 | LOXO-ENC-23001 | A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors | Phase Ia/Ib | The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years. | RECRUITING | LY4101174 | Madrid Sevilla Barcelona | Eli Lilly and Company | |||||||||
| 2023-509632-26-00 | 6330064 | DS7300-203 | A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02) | Phase Ia/IIb | This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors previously treated with 1 or more systemic therapies for the selected tumor indication. The study will be divided into 2 parts: Stage 1 and Stage 2. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. | RECRUITING | Ifinatamab deruxtecan | H.U. 12Octubre H.U. Gregorio Marañon H.U. Clinico San Carlos H.U. La Paz H.U. Virgen Macarena H. Clinic(BCN) ICO-Hospitalet H.U. Vall d'Hebron | Daiichi Sankyo | |||||||||
Observationals & Traslational Studies H&N Cancer | ||||||||||||||||||
| N.A | 5059444 | 02-MX-003 | ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation | NA | The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment. | RECRUITING | Diagnostic Test: Guardant Reveal | 13 Sites in Spain | Guardant Health, Inc. | |||||||||
| N.A | 5106608 | PBM_CANCER21 | Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study. Head and Neck Cancer Head and Neck Neoplasms Xerostomia | Not Applicable | Participants who meet the inclusion and exclusion criteria will be randomized to one of the three study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked. | RECRUITING | Energy density photobiomodulation (7.5 J/cm2) Energy density photobiomodulation (3 J/cm2) Sham placebo | Universidad de Granada | Universidad de Granada | |||||||||
| N.A | 5562375 | 3011202123121 | Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders | Cohort Prospective | Oral potentially malignant disorders (OPMDs) are chronic pathologies which can suffer dysplastic alterations and evolve into oral cancer. The diagnosis of those pathologies is commonly done by visual inspection, which is not capable of determining the presence or not of dysplasia. Furthermore, this type of diagnosis depends greatly on the expertise and training of the professional. | RECRUITING | Device: GOCCLES Diagnostic Test: Toluidine blue stain Procedure: Biopsy | Universidad Rey Juan Carlos | Universidad Rey Juan Carlos | |||||||||
| N.A | 5483374 | INT 43/21 | The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers (EURACAN) | Cohort | Head and Neck Cancer Nasopharynx Cancer Nasal Cavity and Paranasal Sinus Cancer Salivary Gland Cancer Middle Ear Carcinoma | RECRUITING | N.A | Fundacion Profesor Novoa Santos A Coruña | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | |||||||||
| NA | 05117775 | HNC-TACTIC | Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC. | Retrospective | The present study aims to describe the clinical characteristics of patients with HNSCC in a real-world setting by analyzing readily available information in the Electronic Health Records (EHRs). This study will gain a deep insight of the clinical characteristics and real-world outcomes of patients with all stages (early, locally advanced, and metastatic) of HNSCC. It will focus on developing two predictive models to apply in the clinical setting, one for electing patients with high-risk of recurrence after radical treatment, and the second one for selecting recurrent or metastatic patients who could benefit from immunotherapy. | RECRUITING | No intervention - Just description and predictive models | Savana Research S.L | Savana Research & Head and Neck Cancer International Group (HNCIG) | |||||||||
| NA | 4098146 | SMDR_RP_v2.0 | International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection | Prospective Case-Control | Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ⥠4 cm secondary to OSSC removal and who require mandibular reconstruction. | RECRUITING | Surgical Resection and Reconstruction | H.U. 12 de Octubre (Cirugia Oral y Maxilofacial) | AO Innovation Translation Center | |||||||||
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