Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España

Actualizado marzo 2025

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Eudra/Eu_CTNCTSTUDY-CodeTITLEPHASEINDICATIONSTATUSDRUGSSITESSPONSOR
2024-516779-33-005784012TTCC-2022-01 RADIANPhase 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/IIMulti-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).RECRUITINGDostarlimab
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)
2024-514953-31-006856213TTCC-2022-02 ERBIOTAXTTCC-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). RECRUITINGCetuximab
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

2023-508613-17-006256588221530A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE)Phase IIIA 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.RECRUITINGDostarlimab
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
2023-506294-36-006129864D798EC00001A 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 IIIThe 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)RECRUITINGVolrustomigICO 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
2024-520386-31-004892173NANORAY-312A 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-HNSCCPhase IIIThis 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.RECRUITINGJNJ-90301900 (NBTXR3); Cetuximab; Radiation TherapyH.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.
2022-502787-20-005280314MK-3475-E40Phase 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 IIThis 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.RECRUITINGIO102-IO103; PembrolizumabH. Clinico Valencia
H. Ramon y Cajal (Madrid)
H. Quirón Dexeus (BCN)
ICO-Badalona
IO Biotech
UNK2984410EORTC-1420-HNCG-ROGPhase 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 CarcinomaPhase IIIThe 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 CarcinomaRECRUITINGIntensity-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
UNK5527782HUDP-CyC-01/2022A 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 IIThe 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.RECRUITINGModified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapyH.U. Doctor Peset (Valencia)
H. Gandia (Alicante)
H. Villajoyosa (Alicante)
H.U. Doctor Peset

RECURRENT-METASTATIC H&N

2023-510323-30-006525220MCLA-158-CL03This 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 IIIPrevious 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.RECRUITINGPetosemtamab
Pembrolizumab
2 sites Madrid
Marbella
Valencia
C.H. Pamplona
CUN
Merus N.V.
2023-510322-32-006496178MCLA-158-CL02A 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 CarcinomaPhase IIIA Phase 3 Study to Evaluate Petosemtamab Compared with Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma PatientsRECRUITINGPetosemtamab
Investigator's Choice
2 sites Madrid
Barcelona
Valencia
C.H. Pamplona
CUN
Merus N.V.
2023-505606-42-006064877AV-299-23-301A 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 IIIThe 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.RECRUITINGFiclatuzumab
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.
2023-506308-24-006082167XL092-305A 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/IIIThis 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.RECRUITINGZanzalintinib
Zanzalintinib-matched Placebo
Pembrolizumab
5 centros Madrid
1 centro BCN
ICO-Girona
1Centro Coruña
1centro Pamplona
1centro Sevilla
1centro Zaragoza
1centro Valencia
Exelixis
2024-515538-34-006295731INBRX106-01-201A 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/IIIThis 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.RECRUITINGINBRX-106
Pembrolizumab
H. Quiron Salud BarcelonaInhibrx Biosciences, Inc
2023-503428-24-006062420219885A 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-202Phase IIThe 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).RECRUITINGDostarlimab
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
2023-508418-40-00638508061186372HNC2002A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/​Metastatic Head and Neck Cancer (OrigAMI-4)Phase IIThe 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.RECRUITINGAmivantamab
Pembrolizumab
Paclitaxel
Carboplatine
H.12 Octubre
H. Ramon y Cajal
ICO - Hospitalet
H. Vall d'Hebron
Janssen Research & Development, LLC
2024-512671-12-004534205BNT113-01An 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 IIA 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)RECRUITINGBNT113
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
2023-508561-33-004183166TG4050.02A 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/IIThis 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).RECRUITINGTG4050ICO-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
2022-503055-26-006016920VB-C-03A 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/IIAThe 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 pembrolizumabRECRUITINGVB10.16
Pembrolizumab
ICO-Hospitalet
H. del Mar (BCN)
H. Virgen de las Nieves (Granada)
M.D.Anderson (Madrid)
Nykode Therapeutics ASA
2023-510307-22-0049582391463-0001An 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 IParticipants 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.RECRUITINGBI 765179
Ezabenlimab
Pembrolizumab
H.Clinico San Carlos (Madrid)
H. Vall d Hebron (BCN)
ICO-Badalona
CUN
Boehringer Ingelheim
2024-511477-29-006648096IRSSP-001Phase 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/IIThe 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 AfatinibH.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

2024-514461-19-004868877MCLA-129-CL01Phase 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/IIA 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 monotherapyRECRUITINGMCLA-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.
2024-513627-16-013526835MCLA-158-CL01Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors.Phase I/ IIThis 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.RECRUITINGMCLA-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.
2023-503651-10-004895709CA052-002A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors.Phase I/ IIThe 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.RECRUITINGBMS-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
2023-505334-10-015592626CP-START-001A 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/IIThis 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
RECRUITINGSTAR0602H.Vall d'Hebron
Start-Fjimenez Diaz
Marengo Therapeutics, Inc.
UNK4585750KEYNOTE-D79A 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/IIThis 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.RECRUITINGRezatapopt
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
2024-510655-36-004180371BT5528-100Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression.Phase I/ IIThis 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 EphA2RECRUITINGBT5528
Nivolumab
ICO Hospitalet
H. Vall d'Hebron (BCN)
H. 12 Octubre (Madrid)
Start_Sanchinarro (Madrid)
Start_F.J.Diaz (Madrid)
BicycleTx Limited
2023-506228-10-006305247CLIN-01194-450An 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 TumoursPhase I/IIAThe 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).RECRUITINGIPN01194
IPN01194
H. Vall d'Hebron (BCN)
Start_F.J.Diaz (Madrid)
M.D.Anderson (Madrid)
Ipsen
2023-506539-14-005983432BL-B01D1-LUNG-101Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid TumorsPhase IThe 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.RECRUITINGBL-B01D1Star_Sanchinarro (Madrid)
Start_F.J. Díaz (Madrid)
SystImmune Inc.
2022-502381-25-015544929CKFA115A12101A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced CancersPhase IThe 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
RECRUITINGKFA115
Pembrolizumab
H. Vall d'Hebron (BCN)Novartis Pharmaceuticals
2023-507641-29-006172478U31402-277HERTHENA-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 TumorsPhase IThis 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.RECRUITINGHER3-DXdH.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
2023-504807-94-005768139STX-478-101First-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 TumorsPhase IStudy 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.RECRUITINGSTX-478
Fulvestrant
Ribociclib
Palbociclib
Madrid
Barcelona
Scorpion Therapeutics, Inc.
2023-505346-26-015683418TOS-358-001A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor, TOS-358, in Adult Subjects with Select Solid TumorsPhase IThe 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?RECRUITINGTOS-358Madrid
Barcelona
Valencia
Pamplona
Totus Medicines
2023-510061-10-005176483XL092-002Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002).Phase IA 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.RECRUITINGZanzalintinib; Nivolumab; Ipilimumab; Nivolumab + RelatlimabH. 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
2022-501570-18-005647122D9350C00001A 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 IThe 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.RECRUITINGAZD9592
Osimertinib
5-Fluorouracil (5-FU)
Leucovorin
Bevacizumab
H. Vall d'Hebron(BCN)
H. Virgen del Rocio (Sevilla)
Start_F J Diaz (Madrid)
Astra Zeneca
2023-506604-18-005208762SGNPDL1V-001A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors.Phase IThis 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.RECRUITINGPF-08046054
pembrolizumab
ICO Hospitalet
H. Vall d'Hebron(BCN)
Start_Sanchinarro (Madrid)
Next-Oncology
Seagen Inc.
2023-508469-34-004389632SGNB6A-001A Phase 1 Study of SGN-B6A in Advanced Solid Tumors.Phase IThe 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.RECRUITINGSigvotatug 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.
2024-511286-11-005238883HFB-200301-01A 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 TumorsPhase IThe 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.RECRUITINGHFB200301
Tislelizumab
H. Vall d'Hebron(BCN)
H. 12 Octubre (Madrid)
H. Clinico Valencia
HiFiBiO Therapeutics
2023-509867-26-006238479LOXO-ENC-23001A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid TumorsPhase Ia/IbThe 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.RECRUITINGLY4101174Madrid
Sevilla
Barcelona
Eli Lilly and Company
2023-509632-26-006330064DS7300-203A 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/IIbThis 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.RECRUITINGIfinatamab deruxtecanH.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.A505944402-MX-003ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy EvaluationNAThe 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.RECRUITINGDiagnostic Test: Guardant Reveal13 Sites in SpainGuardant Health, Inc.
N.A5106608PBM_CANCER21Photobiomodulation 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 ApplicableParticipants 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.RECRUITINGEnergy density photobiomodulation (7.5 J/cm2)
Energy density photobiomodulation (3 J/cm2)
Sham placebo
Universidad de GranadaUniversidad de Granada
N.A55623753011202123121Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant DisordersCohort 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.

RECRUITINGDevice: GOCCLES
Diagnostic Test: Toluidine blue stain
Procedure: Biopsy
Universidad Rey Juan CarlosUniversidad Rey Juan Carlos
N.A5483374INT 43/21The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers (EURACAN)CohortHead and Neck Cancer
Nasopharynx Cancer
Nasal Cavity and Paranasal Sinus Cancer
Salivary Gland Cancer
Middle Ear Carcinoma
RECRUITINGN.AFundacion Profesor Novoa Santos
A Coruña
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NA05117775HNC-TACTICTowards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC.RetrospectiveThe 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.RECRUITINGNo intervention - Just description and predictive modelsSavana Research S.LSavana Research & Head and Neck Cancer International Group (HNCIG)
NA4098146SMDR_RP_v2.0International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) ResectionProspective Case-ControlProspective 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.RECRUITINGSurgical Resection and ReconstructionH.U. 12 de Octubre (Cirugia Oral y Maxilofacial)AO Innovation Translation Center

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