Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España

Actualizado mayo 2022

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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 chemotherapyCerrado reclutamientoNIVOLUMABICO Hospitalet
ICO Girona
ICO Badalona
H.U. Clínic (Barcelona)
H.U. Vall d´Hebron (Barcelona)
H.U. Virgen del Rocío (Sevilla)
C.U.N.
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)
H.U. Lucus Augusti (Lugo)
H.U. Ramón y Cajal (Madrid)
H. Clínico San Carlos (Madrid)
H.U. 12 de Octubre (Madrid)
H.U. de Badajoz
H.U. de Cruces (Barakaldo)
H. Clínico de Valencia
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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2017-001139-383765918MK3475-689A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)Phase IIIThis is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC)RECLUTANDOPembrolizumab
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.
UK3410615 HN9Randomized Phase II Study of Cisplatin Plus Radiotherapy Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Durvalumab Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)Phase IIThis is a non-comparative, randomized, phase II study of cisplatin plus radiotherapy or durvalumab plus radiotherapy followed by adjuvant durvalumab or durvalumab plus radiotherapy followed by adjuvant tremelimumab and durvalumab in intermediate risk, HPV-positive, locoregionally advanced oropharyngeal squamous cell cancer (LA-OSCC) of the head and neck.RECLUTANDORadiation
Cisplatin
Durvalumab
Tremelimumab
C.H. Navarra (Pamplona)
H.U. Vall d´Hebron (Barcelona)
ICO Hospitalet
H.U. Ramón y Cajal
H. Clínico de Valencia
Canadian Cancer Trials Group
UK2984410 EORTC-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.RECLUTANDOIntensity-Modulated Radiation Therapy (IMRT)
Trans Oral Surgery (TOS)
H.U. Ramón y Cajal
H. U. Central de Asturias
European Organisation for Research and Treatment of Cancer - EORTC
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.
2019-000790-234338399AN2025H0301The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaPhase IIIThe BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.RECLUTANDOBuparlisib
Paclitaxel
24 SitesAdlai Nortye Biopharma Co., Ltd.
2018-001437-40 3719690KO-TIP-007A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)Phase IISafety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy (AIM-HN/SEQ-HN)RECLUTANDOTipifarnib (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
2020-004918-3504634825  CP-MGA271-06A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckPhase IIThis is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.RECLUTANDOEnoblituzumab
Retifanlimab
Tebotelimab
H.U. de Badajoz
H.U. Vall d´Hebron (Barcelona)
H.U. Clínic (Barcelona)
H.U. Clínico San Carlos (Madrid)
C.U.N.
H.U. Virgen Macarena (Sevilla)
MacroGenics
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) 2ªLinea.Phase IILenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)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)
C. O. de Galicia
Merck Sharp & Dohme Corp.
Eisai
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 Inhibitor (INTERLINK-1)Phase 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
2020-004093-2104675294 AT148003A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)Phase IIThis is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.RECLUTANDOEvorpacept
Pembrolizumab
H.U.La Paz
H.U.Dexeus
H. Severo Ochoa (Madrid)
H. Regional U. de Málaga
ICO Hospitalet
ALX Oncology Inc.
2020-004662-194675333AT148004A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)Phase IIThis is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.RECLUTANDOCisplatin/Carboplatin
5FU
Evorpacept
Pembrolizumab
H.U.La Paz
H.U.Dexeus
H. Severo Ochoa (Madrid)
H. Regional U. de Málaga
ICO Hospitalet
ICO Badalona
ALX Oncology Inc.
2020-003652-324398524ISA101b-OPC-03-19A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 TherapPhase IIThis will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. Squamous Cell Carcinoma of the OropharynxRECLUTANDOISA101BH.U. Clínic (Barcelona)
H.U. Vall d´Hebron (Barcelona)
ISA Pharmaceuticals
2018-000789-133669718ISA101B-HN-01-17A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)Phase IISquamous Cell Carcinoma of the Oropharynx.
HPV16 Positive
RECLUTANDOISA101b
Cemiplimab
Placebo
ICO Hospitalet
H.U. Sanchinarro (Madrid)
H.U. La Paz (Madrid)
H.U. Clínic (Barcelona)
H.U. Vall d´Hebron (Barcelona)
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 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)RECLUTANDOBNT113
Pembrolizumab
H.U. Clínic (Barcelona)
H.U. La Paz (Madrid)
H.U. Puerta de Hierro (Madrid)
C.H. Jaén
C.U.N.
C. H. Navarra (Pamplona)
ICO Girona
H. Regional U. de Málaga
H.U. de Son Espases (Palma de Mallorca)
Start_F.J.Díaz (Madrid)
H.U. La Fe (Valencia)
H.U. Miguel Servet (Zaragoza)
BioNTech SE
UK4260126PDS0101-HNC-201/
VERSATILE-002
A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects With Recurrent and/or Metastatic HNSCC and High-Risk HPV16 InfectionPhase IIVERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).Not yet recruiting (02/05/22)Pembrolizumab and PDS0101H.U. La Paz (Madrid)
Hospital U. Vall d' Hebron
H.Sanchinarro (Madrid)
H. V. Arrixaca (Murcia)
Hospital U. Virgen Nieves(Granada)
PDS Biotechnology Corp.
2021-000055-394811027TACTI-003/Keynote- PNC-34A Multicenter, Open Label, Randomized, Phase II Trial to Investigate a Soluble LAG-3 Fusion Protein, Eftilagimod Alpha (Efti; IMP321) in Combination With Pembrolizumab (PD-1 Antagonist) for First Line Treatment of Subjects With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)Phase IIEvaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.RECLUTANDOEftilagimod alpha
Pembrolizumab
H. Vall d´Hebron (Barcelona)
H. Sant Pau (Barcelona)
H. Miguel Servet (Zaragoza)
ICO Girona
Start_F.J.Díaz (Madrid)
Immutep S.A.S /Merck
Sharp & Dohme Corp.
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-HNSCC.Not yet recruiting (02/05/22)NBTXR3
Cetuximab
Radiation Therapy
H.U. de Cruces (Barakaldo)
C.H. Navarra (Pamplona)
H.U. Marqués de Valdecilla (Santander)
Nannobiotix

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 IIThe primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors.RECLUTANDOTisotumab vedotinH. U. Vall d´Hebron (Barcelona)
H.U. Ramón y Cajal (Madrid)
H. Quironsalud (Barcelona)
ICO Badalona
Seattle Genetics, Inc
2021-001009-565007106MK-7684A-005A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid TumorsPhase IIParticipants with locally recurrent unresectable or metastatic cervical cancer whose tumors express programmed cell death 1 ligand 1 (PD-LI) and have a combined positive score (CPS) ≥1 will be randomly assigned to treatment with either pembrolizumab/vibostolimab co-formulation or pembrolizumab only. The other study intervention arms will be assigned to participants depending on the selected cancer type.RECLUTANDOPembrolizumab/Vibostolimab Co-Formulation.
Pembrolizumab
Lenvatinib
5-Fluorouracil
Cisplatin
Paclitaxel
ICO Hospitalet
H. U. Ramón y Cajal
H. U. Virgen del Rocío (Sevilla)
H. U. Quironsalud Madrid
Merck Sharp & Dohme Corp.
2019-000722-22406902620201An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Aryl Hydrocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Participants With Advanced Solid TumorsPhase IDose expansion of BAY2416964 in tumor type specific: HNSCC, NSCLC, Urothelial cancer and Colorectal cancer MSSRECLUTANDOBAY2416964ICO Hospitalet
H.U. 12 de Octubre (Madrid)
H. Clínico de Valencia
H.U. Ramón y Cajal (Madrid)
Bayer
2018-004303-403821935M19-345A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid TumorsPhase IThe study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with budigalimab. The study will consist of 2 phases: dose escalation and dose expansion.RECLUTANDOABBV-151
Budigalimab
Start_F.J.Díaz (Madrid)
H. Clínic (Barcelona)
H. Clínico de Valencia
AbbVie
UK4580485INCB 106385-102A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid TumorsPhase 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)
C.U.N.
Start_F.J.Díaz (Madrid)
Start_Sanchinarro (Madrid)
H.U. 12 de Octubre (Madrid)
Incyte Corporation
2019-001965-344044859ADP-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), esophageal or ovarian cancer that express the MAGE-A4 protein.RECLUTANDOAutologous genetically modified ADP-A2M4CD8 cellsH.U. 12 de Octubre
C.U.N.
H. Clínico de Valencia
Start_F.J.Díaz (Madrid)
Start_Sanchinarro (Madrid)
H.U. Virgen del Rocío (Sevilla)
Adaptimmune
2019-004748-314254107SGNTGT-001A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced MalignanciesPhase IThe study will have three parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors.RECLUTANDOSEA-TGT
Sasanlimab
H. U. Vall d´Hebron (Barcelona)
Start_Sanchinarro (Madrid)
Seagen Inc.
2021-001188-264895709CA052-002A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid TumorsPhase 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.Not yet recruiting (02/05/22)BMS-986340
BMS-936558-01
ICO Badalona
2 Sites Madrid
C.U.N.
Bristol-Myers Squibb
2018-003716-474083599GCT1042-01A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid TumorsA First-in-HumanTo evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumorsRECLUTANDOGEN1042
Pembrolizumab
Cisplatin
Carboplatin
5-FU
Gemcitabine
Nab-Paclitaxel
H. U. Vall d´Hebron (Barcelona)
Start_Sanchinarro (Madrid)
Start_F.J.Díaz (Madrid)
M.D. Anderson (Madrid)
C.U.N.
Genmab
2018-003402-633917381GCT1046-01First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid TumorsPh1, first-in-human (FIH) and an expansion part (phase 2a)The 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)
Start_Sanchinarro (Madrid)
H. U. Vall d´Hebron (Barcelona)
MacroGenics
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.
UK1351103CLGK974X2101A 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
ICO Hospitalet
Other sites (no especificados)
Novartis 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
2020-001035-274389632SGNB6A-001A Phase 1 Study of SGN-B6A in Advanced Solid TumorsPhase 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.RECLUTANDOSGN-B6AH.U. Vall d´Hebron (Barcelona)
Start_Sanchinarro (Madrid)
Seagen Inc
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/IIThis is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy.RECLUTANDOCX-2029H.U. Clínic (Barcelona)
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/IIAdvanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.RECLUTANDOMAK683H.U. 12 de Octubre (Madrid)Novartis Pharmaceuticals
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 IThe study will consist of 3 periods: Screening (up to 28 days), Treatment (28-day cycles), and Follow-up (up to 6 months of visits with survival follow-up for select cohorts). Following the dose escalation portion of the study, additional evaluable subjects may be included in order to further characterize safety and efficacy at selected doses and/or in specific patient sub-groupsRECLUTANDOCK-301 (cosibelimab)C.U.N.
H.U. Vall d´Hebron (Barcelona)
H.U. Virgen Macarena (Sevilla)
I. Valenciano de Oncología
H. Regional Universitario de Málaga
H.U. 12 de Octubre (Madrid)
Checkpoint Therapeutics, Inc.
Novotech (Australia) Pty Limited
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 IThis study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.RECLUTANDOABBV-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 IThis is a Phase I, FIH, multicentre, open-label, multiple arm study. Dose-escalation will occur with AZD8701 in monotherapy and in combination with durvalumab in selected participants with HNSCC, and with solid tumours who have demonstrated a response to prior PD-(L)1 treatment.RECLUTANDOAZD8701H.U. Vall d'Hebron (Barcelona)
C.U.N. (Pamplona)
ICO Hospitalet
H.U. 12 de Octubre (Madrid)
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®) with or without chemotherapy.RECLUTANDONKTR-214
Pembrolizumab
Fundación Jiménez Díaz (Madrid)
H.U. Vall d´Hebron (Barcelona)
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)
H.U. Vall d´Hebron (Barcelona)
Start_F.J.Díaz (Madrid)
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
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 therapy: Pain and dysfunctionUniversidad de GranadaUniversidad de Granada
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-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.Not yet recruiting (02/05/22)Surgical Resection and ReconstructionH.U. 12 de Octubre (Madrid)AO Clinical Investigation and Publishing Documentation
NA05117775HNC-TACTICTowards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC.RetrospectiveThis will be an international, multicenter, retrospective, observational, and data-driven study using secondary data captured in EHRs. The extraction of the data captured in the EHRs will be performed with SAVANA's EHRead®, an innovative data-driven system based on Natural Language Processing (NLP) and machine learning. For all patients, the Index Date is defined as the timepoint within the study period when they fulfill ALL inclusion criteria and no exclusion criteria. Follow-up comprises the period between Index Date and the last EHR available within the study period. Additional variable-specific time windows may be considered to optimize data collection.Not yet recruiting (02/05/22)No intervention - Just description and predictive modelsSavan Research S.LSavana Research & Head and Neck Cancer International Group (HNCIG)
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 (02/05/22)Lymphoseek
Nanocoll
H.U. Clínic (Barcelona)Fundacion Clinic per a la Recerca Biomédica
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 (02/05/22)Mobile application (reminder app)H.U. de Cruces (Barakaldo)
H.U. La Fe (Valencia)
University Hospital Schleswig-Holstein

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