Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España
Actualizado enero 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) ed.) | 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) ICO Hospitalet H. Regional de Málaga H. Virgen del Rocío(Sevilla) H. General de Valencia H. Lucus Augusti (Lugo) F. J. Díaz (Madrid) H. Sanchinarro (Madrid) Hospital Universitario San Roque F. I. Valenciano De Oncología | 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. | |||||||||
| UNK | 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 | 8 Sites | 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. | Not yet Recruiting | Xevinapant Placebo | H. Vall d Hebron (BCN) ICO-Hospitalet | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| 2020-004093-21 | 04675294 | AT148003 | A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) | Phase II | This 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. | RECLUTANDO | Evorpacept Pembrolizumab | H.U.La Paz (Madrid) H.U.Dexeus(BCN) H.Severo Ochoa (Leganes) H.Regional Málaga H.U. Navarra ICO Hospitalet H.Sanchinarro (Madrid) | ALX Oncology Inc. | |||||||||
| 2020-004662-19 | 4675333 | AT148004 | A 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 II | This 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. | RECLUTANDO | Cisplatin/Carboplatin; 5FU Evorpacept Pembrolizumab | H.U. La Paz (Madrid) H.U.Dexeus (BCN) H.Severo Ochoa (Leganes) H.Regional Málaga ICO Hospitalet ICO Badalona H. Sanchinarro (Madrid) H. U. de Navarra | ALX Oncology Inc. | |||||||||
| 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 | |||||||||
| 2020-005708-20 | 4854499 | GS-US-548-5916 | A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (ELEVATE HNSCC) | Phase II | The primary objectives of the safety run-in cohorts of this study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab in participants with head and neck squamous cell carcinoma (HNSCC) | RECLUTANDO | Magrolimab Pembrolizumab Docetaxel 5-FU Cisplatin Carboplatin Zimberelimab | H. Sant Pau (BCN) H. La Paz (Madrid) H. La Fe H. Virgen del Rocio (Sevilla) H. Clinico Valencia H.U. Virgen Macarena (Sevilla) H. Regional Málaga H. U. Jaen H. del Mar (BCN) MD Anderson(Madrid) H. Vall Hebron (BCN) C.U.N H. Gregorio Marañón (Madrid) | Gilead Sciences | |||||||||
| 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). | Not yet Recruiting | 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. | |||||||||
| 2021-003473-59 | 5249426 | 1443-0002 | An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) | Phase I | HNSCC: Patients will be randomized into cohort A, B, with 2nd line recurrent/metastatic HNSCC who had received prior platinum-based therapy within the recurrent/metastatic setting. | RECLUTANDO | BI 765063 Ezabenlimab Cetuximab Investigator´s Choice Chemotherapy | H. Vall d' Hebron(BCN) ICO-Hospitalet H. Clinico San Carlos (Madrid) | Boehringer Ingelheim | |||||||||
| 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 | |||||||||
| 2020-003652-32 | 4398524 | ISA101b-OPC-03-19 | A 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 Therapy | Phase II | This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. Squamous Cell Carcinoma of the Oropharynx | RECLUTANDO | ISA101B | H.U. Clínic (BCN) H.U. Vall d´Hebron (BCN) C.U.N ICO-Hospitalet | ISA Pharmaceuticals | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| 2023-503740-14 | 5712356 | LSTA1-P02 | A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors | Phase II | The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma and cholangiocarcinoma. | Not yet Recruiting | LSTA1 Paclitaxel Durvalumab Cisplatin Gemcitabine Placebo | H.U. Vinalopo- Elche (Alicante) H. U. Jerez de Frontera H. Quiron Málaga H.U. La Paz (Madrid) H. Torrejón (Madrid) H. Sanchinarro(Madrid) H. Sant Pau (BCN) | Lisata Therapeutics, 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 | |||||||||
| 2021-004855-18 | 5176483 | XL092-002 | Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002). | Phase I | A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors. | 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. | 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. | 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) | 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. Tumor indications include head and neck cancer. | 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) | Seagen Inc. | |||||||||
| CTIS: 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 | |||||||||
| 2021-004854-46 | 5229601 | HFB-301001-01 | A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors | Ph1, first-in-human and an expansion | This is a Phase I, first-in-human, open-label, dose escalation and expansion study in adult patients with advanced cancers. Head and neck squamous cell carcinoma previously at least 2 lines of therapy. | RECLUTANDO | HFB301001 | H. Vall d'Hebron(BCN) H. Clinico Valencia H. 12 Octubre(Madrid) | HiFiBiO Therapeutics | |||||||||
| 2018-003402-63 | 3917381 | GCT1046-01 | First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors. Tumor indications Include Squamous Cell Carcinoma of the Head and Neck. | Phase 1, first-in-human and an expansion part (phase 2a) | The purpose of the trial is to evaluate the safety of GEN1046 as monotherapy and in combination therapies in patients with malignant solid tumors. | RECLUTANDO | GEN1046 GEN1046 in combination with docetaxel (in a single expansion cohort) GEN1046 in combination with pembrolizumab (in a separate expansion cohort) | H. Vall d'Hebron(BCN) H. 12 Octubre (Madrid) Start-FJD (Madrid) Start-Sanchinarro (Madrid) Next Oncolgy (Quirón-Madrid) H. Quirón (Barcelona) CUN H.U. La Princesa (Madrid) MD.Anderson(Madrid) H.Virgen Victoria(Malaga) H.Clinico Valencia | Genmab | |||||||||
| 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. | 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 | |||||||||
| 2018-003402-63 | 3917381 | GCT1046-01 | First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors. | Ph1, first-in-human and an expansion part (phase 2a) | The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors | RECLUTANDO | GEN1046 Docetaxel Pembrolizumab | C.U.N Next Oncology (Quiron-Madrid & BCN) H. Vall d´Hebron (BCN) Start_F.J.Díaz (Madrid) Start_Sanchinarro (Madrid) H. Clínico de Valencia H. 12 de Octubre (Madrid) H. La Princesa (Madrid) M.D. Anderson (Madrid) H. Virgen de la Victoria (Málaga) | Genmab A/S | |||||||||
Estudios Academicos/Observacionales de Cáncer de Cabeza y Cuello | ||||||||||||||||||
| N.A | 6122636 | 22/2021 | Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study | Not Applicable | Conditions Quality of Life Oral Mucositis Dental Plaque Periodontal Diseases Xerostomia Dysbiosis | RECLUTANDO | Dietary Supplement: The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory Other: Placebo | Universidad de Barcelona | Universidad de Barcelona | |||||||||
| 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 | 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 | 5936502 | EPIC-iENE DATA | Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer Part of the Evaluation Prognostic and Predictive Indicators in Head and Neck Cancer (EPIC) Programme, Run Under the Auspices of the Head and Neck Inter Group (HNCIG, Www.Hncig.Org) | Retrospective | Head and Neck Squamous Cell Carcinoma Extranodal Extension Human Papilloma Virus Related Carcinoma | RECLUTANDO | Extranodal extension | Instituto Catalan de Oncologia (BCN) | Head and Neck Cancer International Group | |||||||||
| 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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