Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España
Actualizado junio 2024
Información Pública obtenida a partir de: Clinical Trials.gov; EU Clinical Trials Register; REEC (AEMPS)
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| EudraCT-Number | NCT | CÓDIGO-ESTUDIO | TÍTULO ESTUDIO | FASE | INDICACIÓN | ESTADO | MEDICACIÓN | CENTRO | PROMOTOR | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-000183-65 | 5784012 | TTCC-2022-01 RADIAN | Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo) RadIotherapy in Locally-Advanced; Head and Neck Squamous Cell Carcinoma. | Phase 1b/II | Multi-center, open-label, non-randomized, non-comparative two-cohort study for patients with locally-advanced squamous cell carcinoma arising from the larynx, hypopharynx, oropharynx (Stage III, IVA and IVB according to 8th TNM/AJCC ed.) and oral cavity (unresectable, stage IVB according to 8th TNM/ American Joint Committee on Cancer (AJCC). | RECLUTANDO | Dostarlimab Niraparib Radiation Therapy | ICO Hospitalet H.U. Clínic (BCN) ICO Badalona H.U. Vall d´Hebron (BCN) C.H. Navarra (Pamplona) | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC) | |||||||||
| UNK | 5280314 | KEYNOTE-E40 | Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab in Patients With Selected Resectable Tumors. | Phase II | This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications. | RECLUTANDO | IO102-IO103 Pembrolizumab | H. Clinico Valencia H. Ramon y Cajal (Madrid) H. Quirón Dexeus (BCN) | IO Biotech | |||||||||
| 2017-004936-13 | 3576417 | GORTEC 2018-01 | A 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 Neck | Phase III | The 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 endpoint ) | RECLUTANDO | Cisplatin Nivolumab Radiation Therapy | ICO Hospitalet ICO Girona ICO Badalona H.U. Clínic (BCN) H.U. Vall d´Hebron (BCN) H.U. Virgen del Rocío (Sevilla) C. Hospitalario Navarra H. Regional de Málaga H.U.M. de Valdecilla (Santander) H.U. Virgen de las Nieves (Granada) H.Lucus Augusti (Lugo) H.Ramon y Cajal(Madrid) H.12 de Octubre (Madrid) H.U.Badajoz H.U.Cruces (Bilbao) H.Clinico de Valencia | GORTEC | |||||||||
| UNK | 2984410 | EORTC-1420-HNCG-ROG | Phase III Study Assessing the "Best of" Radiotherapy Compared to the "Best of" Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma | Phase III | The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC. Oropharyngeal Cancer Supraglottic Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma | RECLUTANDO | Intensity-Modulated Radiation Therapy (IMRT). Trans Oral Surgery (TOS) | H.U. Ramón y Cajal (Madrid) H. U. Central de Asturias H.U. Donostia (not yet recruiting) | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| UNK | 4892173 | NANORAY-312 | A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC | Phase III | This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC. | RECLUTANDO | NBTXR3 Cetuximab Radiation Therapy | H.U.Cruces(Bilbao) C.Hospitalario Navarra H.M.de Valdecilla(Santander) H. Clínic (BCN) H. 12 Octubre (Madrid) H. Vall d Hebron(BCN) | Nanobiotix | |||||||||
| 2022-001144-18 | 5386550 | MS202359_0002 | A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION) | Phase III | The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. | RECLUTANDO | Xevinapant (Debio 1143) Radiation: IMRT Placebo | H. Regional de Málaga CHU A Coruña ICO Badalona ICO Hospitalet H. Vall d Hebron(BCN) H. del Mar (BCN) H. Virgen del Rocio (Sevilla) C.U.N H. Lucus Augusti (Lugo) F. Jimenez Diaz(Madrid) H.I.de las Palmas (Gran Canaria) H.U.La Paz (Madrid) H. Clinic (BCN) | EMD Serono Research & Development Institute, Inc. | |||||||||
| 2023-508613-17-00 | 6256588 | 221530 | A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE) | Phase III | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma. | RECLUTANDO | Dostarlimab Placebo | H.U.Marques Valdecilla (Santander) C.H. Navarra C.H. Salamanca H. U. Miguel Servet (Zaragoza) H. Lucus Augusti (Lugo) H.U. Cruces (Bilbao) H. U. 12 Octubre (Madrid) H.U.La Paz (Madrid) H. Clinico San Carlos (Madrid) H.U. Jerez de la Frontera (Cadiz) | GlaxoSmithKline | |||||||||
| 2023-506294-36-00 | 6129864 | D798EC00001 | A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected LocallyAdvanced (Head and Neck Squamous Cell Carcinoma), Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC) | Phase III | The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT) | Not yet Recruiting | Volrustomig | ICO Badalona H. Vall d Hebron(BCN) H. Clinic (BCN) H. Clinico San Carlos (Madrid) H.U.Ramon y Cajal (Madrid) H. General Valencia H. U. La Fe (Valencia) H. U. Gregorio Marañon (Madrid) H. U. Jaen | AstraZeneca | |||||||||
| UNK | 5527782 | HUDP-CyC-01/2022 | A Phase II Study of Efficacy and Safety of Induction Modified TPF (mTPF) Followed by Concurrent Chemoradiotherapy (CCRT) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LASCCHN) | Phase II | The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer. | RECLUTANDO | Modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy | H.U. Doctor Peset (Valencia) | Hospital Universitario Doctor Peset | |||||||||
| 2022-502339-20-00 | 5724602 | EORTC 2120-HNCG | Radiotherapy Plus Xevinapant or Placebo in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma: a Randomized Phase II Study. RAVINA | Phase II | This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx. | RECLUTANDO | Xevinapant Placebo | H. Vall d Hebron (BCN) ICO-Hospitalet | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| UNK | 5287113 | INCAGN 2385-203 | A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). | Phase II | The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). | RECLUTANDO | Retifanlimab INCAGN02385 INCAGN02390 Placebo | ICO-Badalona ICO-Girona F. Jimenez Diaz (Madrid) H. Ramon y Cajal (Madrid) H. Regional de Málaga H. Quirón (Madrid) C. H. Navarra H.U.M.Valdecilla (Santander) H. U. General de Valencia H. U. La Fe | Incyte Biosciences International Sàrl | |||||||||
| 2023-503428-24-00 | 6062420 | 219885 | A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck | Phase II | The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC). | RECLUTANDO | Dostarlimab Belrestotug GSK6097608 | 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 H. Vall d'Hebron(BCN) H.U.M.Valdecilla(Santander) H. Clinico San Carlos (Madrid) H. U. General de Valencia | GlaxoSmithKline | |||||||||
| 2019-000569-19 | 4428151 | MK-7902-009 | A 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) | Phase II | Lenvatinib (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) | RECLUTANDO | Pembrolizumab Lenvatinib Docetaxel Capecitabine Paclitaxel Cetuximab | ICO Hospitalet H. General de Valencia H. Clinic (BCN) H.U. Ramón y Cajal (Madrid) H. Virgen Victoria (Málaga) C. Oncológico Galicia | Merck Sharp & Dohme Corp. Collaborator: Eisai Inc. | |||||||||
| 2023-506092-10-00 | 5980598 | ASND0038 | BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma | Phase II | This trial starts with a safety run-in of 12 participants, 6 participants each in Arms A (TransCon TLR7/8 Agonist plus pembrolizumab) and B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ) randomized 1:1. After completing the safety run-in, 80 participants will be randomized in a 2:2:1 ratio in 3 treatment Arms A, B or C (pembrolizumab monotherapy). Once randomized, participants should begin treatment within 5 calendar days. Participants enrolled after the safety run-in, into the 2:2:1 randomization part of the trial, will be stratified as follows: oropharyngeal HPV p16 positive versus oropharyngeal HPV p16 negative or larynx/hypopharyngeal/oral cavity regardless of HPV p16 status. All participants should receive study drug(s) every 21 days (Q21D) for 2 cycles followed by curative-intent surgery. After surgery, participants may receive standard-of-care treatment in the adjuvant setting, as per investigator's decision and local guidelines | RECLUTANDO | TransCon TLR7/8 Agonist Pembrolizumab TransCon IL-2 β/γ | 14 Sites | ASCENDIS PHARMA ONCOLOGY DIVISION A/S (DENMARK) | |||||||||
| UNK | 5909904 | BGB-HNSCC-201 | A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | Phase II | This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). | RECLUTANDO | Tislelizumab BGB-A425 LBL-007 | ICO-Hospitalet H. Clinico San Carlos (Madrid) H. U. Miguel Servet (Zaragoza) H. U. Virgen Rocio (Sevilla) | BeiGene | |||||||||
| 2020-001400-41 | 4534205 | BNT113-01 | An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT) | Phase II | A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 (AHEAD-MERIT) | RECLUTANDO | BNT113 Pembrolizumab | H.U. Clínic (BCN) H.U. La Paz (Madrid) H.U. Puerta de Hierro (Madrid) C.H. Jaén C.U.N ICO Girona H. Regional de Málaga H.U. Son Espases (P.Mallorca) Start_F.J.Díaz (Madrid) H.La Fe H.Miguel Servet (Zaragoza) | BioNTech SE | |||||||||
| 2019-000907-34 | 4180215 | H-200-001 | Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients With HPV 16+ Confirmed Cancers | Phase I/II | This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. | RECLUTANDO | HB-201 HB-202 | H. Sant PAU(BCN) H. Clinic (BCN) H. Vall d Hebron(BCN) Start_F.J. Diaz (Madrid) Start_Sanchinarro (Madrid) H. Virgen del Rocio (Sevilla) H. Virgen Macarena (Sevilla) | Hookipa Biotech GmbH | |||||||||
| 2022-503055-26-00 | 6016920 | VB-C-03 | A Phase 1/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 and Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head-Neck Squamous Cell Carcinoma | Phase I/IIA | The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab | RECLUTANDO | VB10.16 Pembrolizumab | ICO-Hospitalet H. del Mar (BCN) H. Virgen de las Nieves (Granada) M.D.Anderson (Madrid) | Nykode Therapeutics ASA | |||||||||
| UNK | 6054477 | ALE.C04.01 | A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. | Phase I/II | The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer. | RECLUTANDO | ALE.C04 Pembrolizumab | H. Clinico de Santiago Compostela H. Clinico de Valencia M.D. Anderson (Madrid) | Alentis Therapeutics AG | |||||||||
| 2023-505796-76-00 | 6056310 | MS202359_0025 | Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX) | Phase I | The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy. | RECLUTANDO | Xevinapant Cisplatin Radiation: intensity-modulated radiation therapy (IMRT) | ICO-Girona F. Jimenez Diaz (Madrid) CUN (Madrid) H. U. Virgen del Rocio (Sevila) | EMD Serono Research & Development Institute, Inc. | |||||||||
| 2020-000075-20 | 4465487 | R6569-ONC-1933 | A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies, Conditions: Squamous cell carcinoma of Head and Neck. | Phase I | There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. | RECLUTANDO | REGN6569 Cemiplimab | ICO Hospitalet H. Vall d Hebron (BCN) Start_F J Diaz (Madrid) Start_Sanchinarro (Madrid) M.D-Anderson (Madrid) H. Ramón y Cajal (Madrid) | Regeneron Pharmaceuticals | |||||||||
Tumores Sólidos con Cohorte de Cáncer de Cabeza y Cuello | ||||||||||||||||||
| 2021-003026-69 | 5077709 | IOB-022/ KEYNOTE-D38 | IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN. | Phase II | A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of Head or Neck (SCCHN). | RECLUTANDO | IO102-IO103 in combination with pembrolizumab | H. Clinico de Valencia H. U. Virgen Macarena (Sevilla) H. U. Virgen Victoria(Malaga) F. J. Diaz (Madrid) H. Ramon y Cajal (Madrid) ICO-Girona ICO-Badalona H. Lozano Blesa (Zaragoza) H. Valle Hebron (BCN) H. 12 Octubre (Madrid) | IO Biotech | |||||||||
| 2018-001608-12 | 3645928 | IOV-COM-202 | Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors. | Phase II | Tumores sólidos incluyendo melanoma metastásico avanzado (MM) o irresecable, carcinoma epidermoide de cabeza y cuello avanzado (CECC) y cáncer de pulmón no microcítico (CPNM) . 1ªLINEA o SUCESIVAS. | RECLUTANDO | Proleukin Pembrolizumab | ICO Hospitalet H.U. 12 de Octubre (Madrid) Star_Sanchinarro (Madrid) Start_F.J. Díaz (Madrid) H.M. de Valdecilla (Santander) | Iovance Biotherapeutics.Inc | |||||||||
| 2021-001009-56 | 5007106 | 7684A-005/ MK-7684A-005 | A 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 Tumors. MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005). | Phase II | Participants 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. | RECLUTANDO | Pembrolizumab/Vibostolimab Co-Formulation Pembrolizumab Lenvatinib 5-Fluorouracil Cisplatin Paclitaxel Gemcitabine Carboplatin Docetaxel Bevacizumab Capecitabine Oxaliplatin | ICO-Hospitalet H. Ramon y Cajal (Madrid) H. Virgen del Rocio (Sevilla) H. Quiron Madrid C.U.N | Merck Sharp & Dohme LLC | |||||||||
| 2017-005076-26 | 3485209 | SGNTV-001 | Open label phase 2 study of Tisotumab Vedotin for locally advanced or metastatic disease in SOLID TUMORS. Carcinoma, Squamous Cell of Head and Neck. | Phase II | The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. | RECLUTANDO | Tisotumab vedotin Pembrolizumab Carboplatino Cisplatino | H.U.Vall d´Hebron (BCN) H.U. Ramón y Cajal (Madrid) H. Quiron (Barcelona) ICO Badalona H.de Manresa (BCN) | Seagen Inc. Genmab Merck Sharp & Dohme LLC | |||||||||
| UNK | 5077709 | KEYNOTE-D38 | A Phase II Multi-Arm (Basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination With Pembrolizumab, as First-Line Treatment for Patients With Metastatic NSCLC, SCCHN, or Metastatic mUBC | Phase II | A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC) | RECLUTANDO | IO102-IO103 in combination with pembrolizumab | 10 Sites | IO Biotech | |||||||||
| UNK | 4585750 | KEYNOTE-D79 | A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | Phase I/II | This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation. | Not yet Recruiting | PC14586 pembrolizumab | 5 Sites | PMV Pharmaceuticals, Inc | |||||||||
| 2021-001403-33 | 4799054 | TCTLR-101 | Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies. | Phase I/II | Advanced Solid Tumor Locally Advanced Solid Tumor Metastatic Solid Tumor Head and Neck Squamous Cell Carcinoma HNSCC HPV-associated Cancers Neoadjuvant Melanoma Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC) | RECLUTANDO | TransCon TLR7/8 Agonist Pembrolizumab | 13 Sites paticipating in Spain | Ascendis Pharma Oncology Division A/S | |||||||||
| 2021-000203-20 | 4868877 | MCLA-129-CL01 | Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors (H&N..) | Phase I/II | A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 as monotherapy | RECLUTANDO | MCLA-129 Osimertinib | H. U. Vall d'Hebron (BCN) Start_F.J.Diaz(Madrid) C.U.N Start_Sanchinarro(Madrid) Next_Oncology (Quiron-Barcelona y Madrid) H.M. Delfos (BCN) H. Sant Pau (BCN) H. Gregorio Marañón (Madrid) H. 12 Octubre (Madrid) H. La Fé I.Oncológico de Valencia (IVO) | Merus N.V. | |||||||||
| 2021-001329-29 | 5060432 | TIG-006 | A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors. Tumor Indications Include Head and Neck Squamous Cell Carcinoma (HNSCC) | Phase I/II | This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors | RECLUTANDO | EOS-448 Pembrolizumab Inupadenant Dostarlimab SOC chemotherapies | 14 Sites paticipating in Spain | iTeos Belgium SA GlaxoSmithKline iTeos Therapeutics | |||||||||
| 2021-001188-26 | 4895709 | CA052-002 | A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors. Tumor indications include Head and Neck Squamous Cell Carcinoma. | Phase I/ II | The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. | RECLUTANDO | BMS-986340 BMS-936558-01 Docetaxel | ICO-Badalona Start_Sanchinarro(Madrid) Start_F.J.Diaz(Madrid) C.U.N H. Vall d'Hebron (BCN) H. V. de la Victoria (Málaga) | Bristol-Myers Squibb | |||||||||
| 2019-003653-29 | 4180371 | BT5528-100 | Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression. | Phase I/ II | This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2 | RECLUTANDO | BT5528 Nivolumab | ICO Hospitalet Start_Sanchinarro (Madrid) Start_F.J.Diaz (Madrid) H. Vall d'Hebron (BCN) H. 12 Octubre (Madrid) | BicycleTx Limited | |||||||||
| 2017-004745-24 | 3526835 | MCLA-158-CL01 | Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors. Tumor indications include Head and Neck Cancer. | Phase I/ II | This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the RP2D of MCLA-158 single agent in patients with mCRC. | RECLUTANDO | MCLA-158 MCLA-158 +Pembrolizumab | H. 12 DE Octubre (Madrid) C. H. Navarra I.Valenciano Oncologia (IVO) H. Vall d'Hebron (BCN) CUN | Merus N.V. | |||||||||
| UNK | 3504488 | BA3021-001 | CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) | Phase I/ II | The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors. | RECLUTANDO | CAB-ROR2-ADC PD-1 inhibitor | H. 12 DE Octubre (Madrid) H. Sant Pau H. del Mar (BCN) H. Vall d'Hebron (BCN) | BioAtla, Inc. | |||||||||
| UNK | 5060432 | TIG-006 | A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors indications include Head and Neck Cancer | Phase I/ II | This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors. | RECLUTANDO | EOS-448 pembrolizumab inupadenant | 15 Sites | iTeos Belgium SA | |||||||||
| 2023-506228-10-00 | 6305247 | CLIN-01194-450 | An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours | Phase I/IIA | The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally). | Not yet Recruiting | IPN01194 IPN01194 | Start_F.J.Diaz (Madrid) M.D.Anderson (Madrid) H. Vall d'Hebron (BCN) | Ipsen | |||||||||
| 2021-004855-18 | 5176483 | XL092-002 | Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002). Tumor indications include Head and Neck Cancer | Phase I | A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors. | RECLUTANDO | XL092 Nivolumab Ipilimumab Nivolumab + Relatlimab | H. 12 de Octubre (Madrid) H.Virgen del Rocio (Sevilla) H. La Fe H. Cliníc (BCN) C.U.N H. Clinico Valencia H. C. San Carlos (Madrid) F.J. Diaz Madrid H. Ramon y Cajal(Madrid) H. Sant Pau (BCN) H. Vall d'Hebron(BCN) M.D. Anderson (Madrid) H.U. Badajoz | Exelixis | |||||||||
| CTIS: 2022-501570-18-00 | 5647122 | D9350C00001 | A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors. Tumor indications include Head and Neck Neoplasms | Phase I | The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents. | RECLUTANDO | AZD9592 Osimertinib | H. Vall d'Hebron(BCN) Start_F J Diaz (Madrid) H. Virgen del Rocio (Sevilla) | Astra Zeneca | |||||||||
| 2021-003517-19 | 5208762 | SGNPDL1V-001 | A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors. Tumor indications include Head and Neck Neoplasms | Phase I | This study will have three parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers. | RECLUTANDO | SGN-PDL1V | H. Vall d'Hebron(BCN) ICO Hospitalet Start_Sanchinarro (Madrid) | Seagen Inc. | |||||||||
| 2019-001965-34 | 4044859 | ADP-0055-001 | A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Nivolumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS). Tumor indications include head and neck cancer. | Phase I | This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. | RECLUTANDO | Autologous genetically modified ADP-A2M4CD8 cells | H.12 de Octubre (Madrid) C.U.N. H. Clínico de Valencia H. Vall d Hebron(BCN) Start_F.J.Díaz (Madrid) Start_Sanchinarro (Madrid) H.U.Virgen del Rocío (Sevilla) | Adaptimmune | |||||||||
| 2020-001035-27 | 4389632 | SGNB6A-001 | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors. Tumor indications include Head and Neck Squamous Cell Carcinoma | Phase I | The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors. | RECLUTANDO | SGN-B6A Pembrolizumab | H.U. Vall d´Hebron (BCN) Start_Sanchinarro (Madrid) H.M.Valdecilla (Santander) H.M. Nou Delfos (BCN) H. U. de Elche H. U. Ramon y Cajal (Madrid) H.U de Jerez (Cadiz) | Seagen Inc. | |||||||||
| 2022-500540-38-00 | 5462873 | CQEQ278A12101 | A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors | Phase I/Ib | To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma. | RECLUTANDO | QEQ278 | H. Vall d'Hebron (BCN) | Novartis Pharmaceuticals | |||||||||
| 2016-001861-10 | 3114319 | CTNO155X2101 | An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors | Phase I | The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications. | RECLUTANDO | TNO155 TNO155 in combination with EGF816 (nazartinib) | ICO-Hospitalet | Novartis Pharmaceuticals | |||||||||
| 2021-006231-25 | 5238883 | HFB-200301-01 | A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients With Advanced Solid Tumors. Tumor indications include Head and Neck Squamous Cell Carcinoma. | Phase I, first-in-human | The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancer. | RECLUTANDO | HFB200301 Tislelizumab | H. Vall d'Hebron(BCN) H. 12 Octubre (Madrid) H. Clinico Valencia | HiFiBiO Therapeutics | |||||||||
| 2018-003716-47 | 4083599 | GCT1042-01 | A 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 Tumors. Tumor indications include Head and Neck Squamous Cell Carcinoma. | A First-in-Human | To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors | RECLUTANDO | GEN1042 Pembrolizumab Cisplatin Carboplatin 5-FU Gemcitabine Nab-Paclitaxel | H. U. Vall d´Hebron (BCN) H. Clinico de Valencia Start_Sanchinarro (Madrid) H. V. Victoria (Málaga) H. 12 Octubre (Madrid) Start_F.J.Díaz (Madrid) M.D. Anderson (Madrid) H. Virgen del Rocio (Sevilla) C.U.N H. C. San Carlos(Madrid) H. Gregorio Marañón(Madrid) Start_Barcelona (HM Delfos) ICO Hospitalet H.Insular Canarias H.U. Santiago de Compostela H.Lucus Augusti (Lugo) H. La Paz (Madrid) H. Ramon y Cajal (Madrid) | Genmab | |||||||||
Estudios Academicos/Observacionales de Cáncer de Cabeza y Cuello | ||||||||||||||||||
| N.A | 5106608 | PBM_CANCER21 | Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study. Head and Neck Cancer Head and Neck Neoplasms Xerostomia | Not Applicable | Participants who meet the inclusion and exclusion criteria will be randomized to one of the three study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked. | RECLUTANDO | Energy density photobiomodulation (7.5 J/cm2) Energy density photobiomodulation (3 J/cm2) Sham placebo | Universidad de Granada | Universidad de Granada | |||||||||
| N.A | 5562375 | 3011202123121 | Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders | Not Applicable | 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. | RECLUTANDO | Device: GOCCLES Diagnostic Test: Toluidine blue stain Procedure: Biopsy | Universidad Rey Juan Carlos | Universidad Rey Juan Carlos | |||||||||
| N.A | 5604235 | CHUNSC_2021_91 | Effectiveness of Oncological Physiotherapy With Neurodynamics and Kinesitherapy (Active+Passive) on Painful Shoulder Cervical Ganglion Post Cervical Evacuation in Head and Neck Cancer. Due to Accessory Spinal Nerve of the Accessory Spinal Nerve. | Not Applicable | Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer. Shoulder Pain Rehabilitation | RECLUTANDO | Therapeutic upper limb strength exercise treatment. Treatment with passive and active mobilization of the upper limb. | Centro Investigación Fisioterapia y Dolor Alcalá De Henares, Madrid | University of Alcala | |||||||||
| N.A | 5483374 | INT 43/21 | The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers (EURACAN) | Cohort Prospective | Head and Neck Cancer Nasopharynx Cancer Nasal Cavity and Paranasal Sinus Cancer Salivary Gland Cancer Middle Ear Carcinoma | RECLUTANDO | N.A | Fundacion Profesor Novoa Santos A Coruña | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | |||||||||
| N.A | 4721184 | PR299/20 | Prospective: 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. (IMMUNONUTRI) | Prospectivo | The 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) | RECLUTANDO | N.A | ICO Hospitalet | Institut Català d'Oncologia Department of Health, Generalitat de Catalunya | |||||||||
| N.A | 05117775 | HNC-TACTIC | Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC. | Retrospective | The present study aims to describe the clinical characteristics of patients with HNSCC in a real-world setting by analyzing readily available information in the Electronic Health Records (EHRs). This study will gain a deep insight of the clinical characteristics and real-world outcomes of patients with all stages (early, locally advanced, and metastatic) of HNSCC. It will focus on developing two predictive models to apply in the clinical setting, one for electing patients with high-risk of recurrence after radical treatment, and the second one for selecting recurrent or metastatic patients who could benefit from immunotherapy. | RECLUTANDO | No intervention - Just description and predictive models | Savana Research S.L | Savana Research & Head and Neck Cancer International Group (HNCIG) | |||||||||
| N.A | 4098146 | SMDR_RP_v2.0 | International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection | Prospective Case-Control | Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction. | RECLUTANDO | Surgical Resection and Reconstruction | H.U. 12 de Octubre (Madrid) | AO Clinical Investigation and Publishing Documentation | |||||||||
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