Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España

Actualizado septiembre 2021

Información Pública obtenida a partir de: Clinical Trials.gov; EU Clinical Trials Register; REEC (AEMPS)

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EudraCT-NumberNCTCÓDIGO-ESTUDIOTÍTULO ESTUDIO FASEINDICACIÓNESTADOMEDICACIÓNCENTROPROMOTOR

ENSAYOS PROMOVIDOS POR TTCC

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2019-002922-604282109TTCC2019-01/CA209-7HE (NIVOTAX)Phase II Multicenter Randomized Trial to Assess the Efficacy and Safety of First Line Nivolumab in Combination With Paclitaxel in Subjects With R/M HNSCC Unable for Cisplatin- based Chemotherapy (NIVOTAX). 1ºLINEA recurrent/metastaticPhase II Patients unable for cisplatin-based chemotherapyRECLUTANDONIVOLUMABICO Hospitalet
H.U. Clínic (Barcelona)
ICO Badalona
ICO Girona
H.U. Clínico San Carlos (Madrid)
H.U. 12 de Octubre (Madrid)
H.U. La Fe (Valencia)
H.U. Miguel Servet (Zaragoza)
C.H. Navarra (Pamplona)
H.U. Lozano Blesa (Zaragoza)
H.U. Virgen del Rocío (Sevilla)
H. Regional de Málaga
H. Clínico Valencia
H.U. Virgen de las Nieves (Granada)
H.U. Virgen de la Salud (Toledo)
H.U. Salamanca
C.O. Galicia (La Coruña)
H.U. de Donostia
H.U. Marqués de Valdecilla (Santander)
H.U. Lucus Augusti (Lugo)
TTCC
2017-004936-133576417GORTEC 2018-01A Phase III Randomized Trial of Post-operative Adjuvant Nivolumab and Concomitant Chemo-radiotherapy in High-risk Patients With Resected Squamous Cell Carcinoma of Head and NeckPhase IIIThe purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpointRECLUTANDOCisplatin
Nivolumab
Radiation Therapy
ICO Hospitalet
ICO Girona
ICO Badalona
H.U. Clínic (Barcelona)
H.U. Vall d´Hebron (Barcelona)
H.U. Virgen del Rocío (Sevilla)
CUN
H. Regional de Málaga
H.U. Miguel Servet (Zaragoza)
H.U. Tenerife
H.U. Marqués de Valdecilla (Santander)
H.U. Virgen de las Nieves (Granada)
GORTEC
N.A4672772TTCC-2019-02 (ERBITAX)Retrospective Study With Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN (Squamous Cell Carcinoma of the Head and Neck): Real World DataRETROSPECTIVEThe main objective will be to estimate the Progression-free survival (PFS) in patients treated with paclitaxel 80 mg/m2 as a starting dose, with weekly cetuximab that could have been switched to biweekly during the maintenance phase, as first line for recurrent and/or metastatic SCCHN.Cerrado ReclutamientoCetuximab
Paclitaxel
ICO Hospitalet
ICO Badalona
ICO Girona
H. Clínico San Carlos (Madrid)
H.U. 12 de Octubre (Madrid)
H.U. Miguel Servet (Zaragoza)
Complejo Hospitalario de Navarra-CHN (Pamplona)
H.U. Virgen de Valme (Sevilla)
H.R. Universitario (Málaga)
H.U. Lucus Augusti (Lugo)
H.U. Virgen de las Nieves (Granada)
C.H. Salamanca
C.O. Galicia (La Coruña)
H.U. Marqués de Valdecilla (Santander)
H.U. Son Espases (Palma de Mallorca)
H.U. Tenerife
TTCC

OTROS PROMOTORES

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2017-001139-383765918MK3475-689Estudio de fase III, aleatorizado y abierto para evaluar pembrolizumab como tratamiento neoadyuvante y en combinación con la asistencia habitual como tratamiento adyuvante en el carcinoma epidermoide de cabeza y cuello locorregionalmente avanzado (CECC LA), extirpable, en estadio III-IVA.Phase IIICarcinoma epidermoide de cabeza y cuello locorregionalmente avanzado (CECC LA), extirpable , en estadio III-IVARECLUTANDOPembrolizumab
Cisplatin
H.U. de Santiago
H.U. La Paz (Madrid)
H.U. Virgen del Rocío (Sevilla)
ICO Hospitalet
ICO Badalona
H.U. Vall d´Hebron (Barcelona)
Merck-Sharp & Dohme Corp.
2019-003717-344199104MK-7902-010A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).Phase IIIThis is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. ECOG:0-1RECLUTANDOPembrolizumab
Lenvatinib
ICO Hospitalet
H.U. Vall d´Hebron (Barcelona)
H.U. 12 de Octubre (Madrid)
H.U. La Paz (Madrid)
H.U. Lozano Blesa (Zaragoza)
H.U. Virgen de Valme (Sevilla)
Merck Sharp & Dohme Corp.
2018-001437-40 3719690KO-TIP-007El estudio AIM-HN y SEQ-HN: Estudio pivotal no comparativo de 2 cohortes para evaluar la eficacia de tipifarnib en pacientes con carcinoma de células escamosas de cabeza y cuello (CCECC) con mutaciones de HRAS (AIM-HN) y el impacto de las mutaciones de HRAS en la respuesta a las terapias sistémicas de primera línea para el CCECC (SEQ-HN).Phase IICarcinoma de células escamosas de cabeza y cuello (CCECC) recurrente o metastásico con mutaciones en HRASRECLUTANDOTipifarnib (oral)H.U. Vall d´Hebron (Barcelona)
H.U. Clínic (Barcelona)
H.U. Santa Creu i Sant Pau (Barcelona)
ICO Hospitalet
H. del Mar (Barcelona)
H.U. La Paz (Madrid)
H.U. 12 de Octubre (Madrid)
H.U. Sanchinarro (Madrid)
H.U. La Fe (Valencia)
H.U. Miguel Servet (Zaragoza)
Complejo Hospitalario de Navarra-CHN (Pamplona)
H.U. de Santiago
H.U. Virgen del Rocío (Sevilla)
H.U. Virgen de la Victoria (Málaga)
H. Costa del Sol (Málaga)
Kura Oncology, Inc
2020-002852-194665843BO42533A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck. (SKYSCRAPER-09)Phase IIThe primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate.RECLUTANDOAtezolizumab
Tiragolumab
Placebo
ICO Hospitalet
ICO Badalona
H.U. La Fe (Valencia)
Hoffmann-La Roche
2019-000569-194428151MK-7902-009A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009) 2ª Línea añade Lenva a PD a Inmunoterapia.Phase II Recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) which has progressed after treatment with both platinum therapy and most recently immunotherapy RECLUTANDOPembrolizumab
Lenvatinib
ICO Hospitalet
H. General de Valencia
H.U. Vall d´Hebron (Barcelona)
H.U. Ramón y Cajal (Madrid)
H.U. Virgen de la Victoria (Málaga)
Merck Sharp & Dohme Corp.
Eisai
2018-002513-363769506ASP-1929-301A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician´s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic TherapyPhase IIILocoregional, recurrent head and neck squamous cell carcinomaRECLUTANDOASP-1929 PhotoimmunotherapyH.U. Sanchinarro (Madrid)
H.U. Vall d´Hebron (Barcelona)
Rakuten Aspyrian, Inc
2019-004770-254590963D7310C00001A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint InhibitorPhase IIIThis is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.RECLUTANDOMonalizumab CetuximabH. Clínico San Carlos (Madrid)
H.U. Gregorio Marañón (Madrid)
H.U. La Paz (Madrid)
H.U. 12 de Octubre (Madrid)
H.U. Vall d´Hebron (Barcelona)
H. General de Valencia
H.U. Lozano Blesa (Zaragoza)
AstraZeneca
2018-000789-133669718ISA101B-HN-01-17Estudio de fase II, aleatorizado, con doble enmascaramiento y controlado con placebo de cemiplimab en comparación con la combinación de cemiplimab más ISA101b en el tratamiento de sujetos con cáncer orofaríngeo (COF) VPH16 - positivo resistente al platinoPhase IICáncer orofaríngeo (COF) VPH-16 positivo resistente al platinoRECLUTANDOISA101b
Cemiplimab
Placebo
ICO Hospitalet
H.U. 12 de Octubre (Madrid)
H.U. Clínico San Carlos (Madrid)
H.U. Sanchinarro (Madrid)
H.U. La Paz (Madrid)
H.U. Clínic (Barcelona)
H.U. Vall d´Hebron (Barcelona)
H.U. Salamanca
H.U. Virgen de la Victoria (Málaga)
H.U. Marqués de Valdecilla (Santander)
ISA-Therapeutics B.V
2020-001400-414534205BNT113-01An 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 IIAn open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1.RECLUTANDOBNT113
Pembrolizumab
H.U. Clínic (Barcelona)
H.U. La Paz (Madrid)
H.U. Puerta de Hierro (Madrid)
C.H. Jaén
CUN
Complejo Hospitalario de Navarra-CHN (Pamplona)
BioNTech SE
2018-001095-383799744ICO-VCN-H&N_2018A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and NeckPhase IMetastasis & RecurrenceRECLUTANDOVCN-01
Durvalumab
ICO Hospitalet
H.U. Vall d´Hebron (Barcelona)
ICO Collaborators:
VCN Biosciencces S.L
BioClever 2005 S.L
Astra Zeneca
2019-003167-224196283M19-894A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaPhase IThe main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).RECLUTANDOABBV-368
Tilsotolimod
Nab-paclitaxel
ABBV-181
H.U. Clínic (Barcelona)
ICO Hospitalet
H.U. 12 de Octubre (Madrid)
Start_Sanchinarro (Madrid)
H.U. Virgen de la Victoria (Málaga)
H. Clínico de Valencia
H.U. Fuenlabrada
AbbVie / Idera
Pharmaceuticals, Inc
UK1946867NBTXR3-102A Phase I Dose-Escalation/Dose Expansion Study Of NBTXR3 Activated By Intensity Modulated Radiation Therapy In Patients With Locally Advanced Squamous Cell Carcinoma Of The Oral Cavity Or OropharynxPhase IThis study consists of two parts: Dose Escalation and Dose Expansion. This phase I is an open-label non-randomized, dose-escalation/dose expansion study of safety and tolerability evaluation of NBTXR3, administered as an intratumoral implantation by injection, activated by intensity modulated radiation therapy (IMRT), in patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx.RECLUTANDONBTXR3 activated by IMRTICO Hospitalet
H.U. Vall d´Hebron (Barcelona)
Start_F.J.Díaz (Madrid)
Start_Sanchinarro (Madrid)
H. Regional de Málaga
Nannobiotix
UK4892173NANORAY-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-HNSCCNot yet recruiting (09/09/21)NBTXR3
Cetuximab
Radiation Therapy
PENDING TO CONFIRMNannobiotix

Tumores Sólidos con Cohorte de Cáncer de Cabeza y Cuello

2018-001608-123645928IOV-COM-202Estudio Fase II, multicentrico de linfocitos de tumores autologos (LN-144 ó LN-145)en pacientes con SOLID TUMORS.Phase IITumores sólidos incluyendo melanoma metastásico avanzado (MM) o irresecable, carcinoma epidermoide de cabeza y cuello avanzado (CECC) y cáncer de pulmón no microcítico (CPNM) . 1ª LINEA o SUCESIVASRECLUTANDOProleukin
Pembrolizumab
H.U. Vall d´Hebron (Barcelona)
ICO Hospitalet
H.U. 12 de Octubre (Madrid)
H.U. Sanchinarro (Madrid)
H.U. Gregorio Marañón (Madrid)
Fundación Jiménez Díaz (Madrid)
H. Regional de Málaga
H.U. Marqués de Valdecilla (Santander)
Iovance Biotherapeutics Inc.
2017-005076-263485209SGNTV-001Open label phase 2 study of Tisotumab Vedotin for locally advanced or metastatic disease in SOLID TUMORS.Phase II4 _COHORTS: Colorectal , NSCLC, Exocrino pancreatic adenocarcinoma and SCCHNRECLUTANDOTisotumab vedotinH. U. Vall d´Hebron (Barcelona)
H.U. Ramón y Cajal (Madrid)
H.U. Sanchinarro (Madrid)
H. Quironsalud (Barcelona)
ICO Badalona
Seattle Genetics, Inc
2017-000241-493207867CNIR178X2201A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin LymphomaPhase IINSCLC, Non Small Cell Lung Cancer
RCC, Renal Cell Cancer
Pancreatic Cancer
Urothelial Cancer
Head and Neck Cancer
DLBCL, Diffused Large B Cell Lymphoma
MSS, Microsatellite Stable Colon Cancer
TNBC, Triple Negative Breast Cancer
Melanoma
RECLUTANDONIR178
PDR001
H.U. Vall d´Hebron (Barcelona)Novartis Pharmaceuticals
2018-001994-253625323TACTI-002(PO15
KEYNOTE-PN798
TACTI-002 (Two ACTive Immunotherapeutics): A multicenter, open label, Phase II study in patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC), or recurrent PD-X refractory NSCLC or with recurrent or metastatic squamous head and neck cancer (HNSCC) receiving the soluble LAG-3 fusion protein eftilagimod alpha (IMP321) in combination with pembrolizumab (PD-
1 antagonist)
Phase IIRecurrent or metastatic squamous head and neck cancer (HNSCC)RECLUTANDOIMP321
Pembrolizumab
H.U. Santa Creu y Sant Pau (Barcelona)
ICO Badalona
H.U. Vall d´Hebron (Barcelona)
Fundación Jiménez Díaz (Madrid)
IMMUTEP S.A.S
2015-003582-282576431LOXOTRX-15002
(NAVIGATE)
A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive TumorsPhase IIARM 8:
Squamous cell cancer of head or neck solid tumors harboring NTRK fusions.
RECLUTANDOLarotrectinib (LOXO-101)H.U. Vall d´Hebron (Barcelona)
H.U. Sanchinarro (Madrid)
Fundación Jiménez Diaz (Madrid)
H.U. Marqués de Valdecilla (Santander)
H. General de Valencia
Bayer
UK4580485INCB 106385-102A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid TuPhase IThis is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, or bladder cancerRECLUTANDOINCB106385
INCMGA00012
H.U. Vall d´Hebron (Barcelona)
CUN
Incyte Corporation
2018-003402-633917381GCT1046-01First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid TumorsPhase 1/2, First-in-HumanThe purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumorsRECLUTANDOGEN1046CUN
H.U. Vall d´Hebron (Barcelona)
Start_F.J.Díaz (Madrid)
Start_Sanchinarro (Madrid)
H. Clínico de Valencia
H.U. 12 de Octubre (Madrid)
H.U. La Princesa (Madrid)
M.D. Anderson (Madrid)
H.U. Virgen de la Victoria (Málaga)
Genmab A/S
2018-003555-383729596 CP-MGC018-01A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid TumorsPhase 1/2, First-in-HumanThe purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumorsRECLUTANDOMGC018
MGA012
H. Ruber Internacional (Madrid)MacroGenics
2019-003998-264424641GCT1044-01First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1044 in Subjects With Malignant Solid TumorsFirst in humanThe purpose of the trial is to evaluate the safety, determine the recommended phase 2 dose, and assess preliminary clinical activity of GEN1044 in subjects with solid tumors.RECLUTANDOGEN1044H.U. Vall d´Hebron (Barcelona)
Start_F.J.Díaz (Madrid)
Genmab/AbbVie
UK4044859ADP-0055-001A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive TumorsPhase IThis study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.RECLUTANDOADP-A2M4CD8 T-cellH.U. 12 de Octubre (Madrid)
H. Clínico de Valencia
CUN
H.U. Virgen del Rocío (Sevilla)
Start_Sanchinarro (Madrid)
Adaptimmune
2019-000446-363894618SL01-DEL-101Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or LymphomasPhase ISquamous Cell Carcinoma of the Head and Neck. MelanomaNon Small Cell Lung CancerUrothelial CarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaSquamous Cell Carcinoma of the AnusSquamous Cell Carcinoma of the CervixSquamous Cell Carcinoma of the SkinRenal Cell CarcinomaHodgkin LymphomaDiffuse Large B Cell LymphomaMismatch Repair Deficient or MSI-High Solid TumorsRECLUTANDOSL-279252H.U. Vall d´Hebron (Barcelona)Shattuck Labs, Inc.
2011-000495-331351103CLGK974X2101A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt LigandsPhase IThis primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies for whom no effective standard treatment is available.RECLUTANDOLGK974
PDR001
No especificado por promotorNovartis Pharmaceuticals
2018-004334-154234113SC103A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid TumorsPhase IHNSCC & Thyroid, A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumorsRECLUTANDOSO-C101
Pembrolizumab
H.U. Vall d´Hebron (Barcelona)SOTIO
2016-003429-413291002CV-8102-008Phase I Study of Intratumoral CV8102 in Patients With Advanced Melanoma, Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Head and Neck, or Adenoid Cystic CarcinomPhase IThis study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.RECLUTANDOCV8102
CV8102 + anti-PD-1 therapy
H.U. Vall d´Hebron (Barcelona)
ICO Hospitalet
H.U. Virgen de la Victoria (Málaga)
H.U. Ramón y Cajal (Madrid)
H.U. Marqués de Valdecilla (Santander)
CureVac AG / Syneos Health
2019-004748-314254107SGNTGT-001A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced MalignanciesPhase IPart C will study how well SEA-TGT with pembrolizumab works to treat solid tumors. Pembrolizumab is a drug that can be used to treat these types of cancer.RECLUTANDOSEA-TGT
Pembrolizumab
H.U. Vall d´Hebron (Barcelona)Seagen Inc.
2017-001475-233289962GO39733A phase 1a/1b, open-label, dose escalation study of the safety and PKs of RO7198457 as a single agent and in combination with Atezolizumab in patients with locally advanced or metastatic Tumors.Phase Ia/Ib8_COHORTS: Melanoma, Bladder Ca, NSCLC, Colorectal, Triple Negative Breast Ca, Renal Ca, H&N Cancer, other Solid Cancers.RECLUTANDOAtezolizumab
RO7198457
H.U. Vall d´Hebron (Barcelona)
CUN
Genentech, Inc.
2017-001553-143150810BGB-290-103A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid TumorsPhase Ibhe primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.RECLUTANDOPamiparib
Temozolomide
H.U. Vall d´Hebron (Barcelona)
ICO Hospitalet
Start_F.J.Díaz (Madrid)
Start _Sanchinarro (Madrid)
H. Clínico de Valencia
H.U. Ramón y Cajal (Madrid)
H.U. Virgen Macarena (Sevilla)
BeiGene
2018-001456-343543813CTMX-M-2029-001A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)Phase I/IIThe purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001RECLUTANDOCX-2029H.U. Clínic (Barcelona)
H.U. La Paz (Madrid)
Start_Sanchinarro (Madrid)
H.U. Vall d'Hebron (Barcelona)
H. Quirónsalud (Madrid)
CytomX Therapeutics
2018-004771-124000529CTNO155B12101A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected MalignanciesPhase IbThis study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.RECLUTANDOTNO155 Spartalizumab RibociclibH.U. Vall d´Hebron (Barcelona)Novartis Pharmaceuticals
2016-001860-122900651CMAK683X2101A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignanciesPhase I/IIH&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.RECLUTANDOMAK683H.U. 12 de Octubre (Madrid)Novartis Pharmaceuticals
2017-001792-243170960XL184-021A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid TumorsPhase IbH&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapyRECLUTANDOAtezolizumab
Cabozantinib
No especificado por promotorExelixis
2018-001463-233212404 CK-301-101A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced CancersPhase ICK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.RECLUTANDOCK-301 (cosibelimab)H.U. Virgen Macarena (Sevilla)
H.U. 12 de Octubre (Madrid)
H. Regional de Málaga
H.U. Vall d´Hebron (Barcelona)
H. General de Valencia
IVO Valencia
Complejo Hospitalario de Navarra-CHN (Pamplona)
H.U. Tenerife
C.H.U. San Cristóbal de La Laguna (Canarias)
Checkpoint Therapeutics, Inc.
Novotech (Australia) Pty Limited
2017-001475-233289962GO39733A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic TumorPhase Ia/IbThis is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).RECLUTANDOAutogene cevumeran
Atezolizumab
H. U. Vall d'Hebron (Barcelona)
CUN
Genentech, Inc.
2019-000478-453893955M19-037A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid TumorsPhase IAdvanced Solid, TumorsTriple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Metastatic Solid TumorsRECLUTANDOABBV-927
ABBV-368
ABBV-181
Docetaxel
H.U. Vall d'Hebron (Barcelona)
H.U. Virgen de la Victoria (Málaga)
Start_F.J.Díaz (Madrid)
Start_Sanchinarro (Madrid)
AbbVie
2019-004539-224504669D9950C00001A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.Phase IThe purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid TumorsRECLUTANDOAZD8701H.U. Vall d'Hebron (Barcelona)
CUN
AstraZeneca
2019-003474-35313888916-214-05A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid TumorsPhase I/IIThis study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®).RECLUTANDONKTR-214
Pembrolizumab
Fundación Jiménez Díaz (Madrid)
H.U. Sanchinarro (Madrid)
H.U. Vall d´Hebron (Barcelona)
H.U. Santa Creu i Sant Pau (Barcelona)
H.U. La Fe (Valencia)
H. Insular de Gran Canaria
Nektar Therapeutics
2020-000075-204465487R6569-ONC-1933A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor MalignanciePhase IFor dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab.RECLUTANDOREGN6569
Cemiplimab
M.D. Anderson (Madrid)
Fundación Jiménez Díaz (Madrid)
H.U. Vall d´Hebron (Barcelona)
Start_Sanchinarro (Madrid)
H.U. Ramón y Cajal (Madrid)
ICO Hospitalet
Regeneron Pharmaceuticals
NA4717765RCT-LB-VE-20Phototherapy With Low Level Laser in the Prevention and Treatment of Oral Lesions (Mucositis, Hyposalivation and Osteonecrosis) Resulting From Anti-neoplastic Treatment With Chemotherapy or Radiotherapy.N.AIn this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene.RECLUTANDODevice: Preventive, LLL Phototherapy and topical Vit E
Device: Curative, LLL Phototherapy and topical Vit E
Device: Preventive, LLL Phototherapy and LPRF
Device: Curative, LLL Phototherapy and LPRF
H.U. de SantiagoUniversity of Santiago de Compostela
2019-003825-564261179SENTINELSEEK-HCAn Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.(SENTINELSEEK)Phase IVComparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagramsNot yet recruiting (09/09/21)Lymphoseek
Nanocoll
H.U. Clínic (Barcelona)Fundacion Clinic per a la Recerca Biomédica
NA4721184PR299/20Prospective: Impact of Body Composition on the Prognosis and Toxicity of Patients Diagnosed With Recurrence or Metastasic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated With Immune Checkpoint Inhibitors (ICI)ProspectivoThe purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)RECLUTANDON.AICO HospitaletInstitut Català d'Oncologia
Department of Health, Generalitat de Catalunya
NA41451800045-N-16Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)ProspectivoThis project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.RECLUTANDOManual therapyUniversidad de GranadaUniversidad de Granada
UK4110977RAREST-02RAdiotherapy RElated Skin Toxicity: A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck CancerUKThe goal of this trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).Not yet recruiting (09/09/21)Mobile application (reminder app)H.U. de Cruces (Barakaldo)
H.U. La Fe (Valencia)
University Hospital Schleswig-Holstein
2018-003352-203768063BO40729An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)Phase IVSquamous cell carcinoma of head and neck, Solid Tumors, NSCLC, Urothelial carcinoma, Renal cell carcinomaRECLUTANDOAtezolizumabCorporació Sànitaria Parc Taulí (Sabadell)
CUN
H.U. Quirónsalud Dexeus
H.U. Clínic (Barcelona)
C.U.N. (Madrid)
H. Regional de Málaga
H.U. Sanchinarro (Madrid)
Hoffmann-La Roche

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