Ensayos Clínicos Cabeza y Cuello
Abiertos a Reclutamiento en España
Actualizado marzo 2023
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (Barcelona) H.U. Vall d´Hebron (Barcelona) H.U. Virgen del Rocío (Sevilla) Complejo Hospitalario Navarra 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 | GORTEC | |||||||||
| 2017-001139-38 | 3765918 | MK3475-689 | A 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 III | This 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) | RECLUTANDO | Pembrolizumab 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. | |||||||||
| 2020-000377-25 | 4459715 | MS202359_0006/Debio 1143-SCCHN-301 | A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) | Phase III | The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). | RECLUTANDO | Xevinapant (Debio 1143) Cisplatin Radiation: Intensity Modulation Radiation Therapy (IMRT) | 25 Sites in Spain | EMD Serono Research & Development Institute, Inc. | |||||||||
| 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. | RECLUTANDO | Intensity-Modulated Radiation Therapy (IMRT) Trans Oral Surgery (TOS) | H.U. Ramón y Cajal (Madrid) H.U. Central de Asturias H.U. de Donostia | 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. de Cruces (Barakaldo) C.H. Navarra (Pamplona) H.U. Marqués de Valdecilla (Santander) H.U. Clínic (Barcelona) H.U. 12 de Octubre (Madrid) H.U. Vall d´Hebron (Barcelona) | Nannobiotix | |||||||||
| 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 C.H.U. A Coruña ICO Badalona ICO Hospitalet H.U. Vall d´Hebron (Barcelona) H. del Mar (Barcelona) H.U. Virgen del Rocío (Sevilla) C.U.N. (MAD) H. Lucus Augusti (Lugo) Fundación Jiménez Díaz (Madrid) H. Insular de las Palmas (Gran Canaria) H.U. La Paz (Madrid) | EMD Serono Research & Development Institute, Inc. | |||||||||
| 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) | H.U. Doctor Peset (Valencia) | |||||||||
| 2020-004093-21 | 04675294 | AT148003 | A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients WithAdvanced 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 H. Severo Ochoa (Madrid) H. Regional U. de Málaga ICO Hospitalet | 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 H. Severo Ochoa (Madrid) H. Regional de Málaga ICO Hospitalet ICO Badalona H. Sanchinarro H.U. de Navarra | ALX Oncology Inc. | |||||||||
| 2021-000055-39 | 4811027 | TACTI-003/Keynote- PNC-34 | A 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 II | Evaluate 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. | RECLUTANDO | Eftilagimod alpha Pembrolizumab | H. Vall d´Hebron (Barcelona) H. Sant Pau (Barcelona) H. Miguel Servet (Zaragoza) ICO Girona Start_F.J. Díaz (Madrid) H.U. Ramón y Cajal (Madrid) H.U. 12 de Octubre (Madrid) H.U. Lucus Augusti (Lugo) | Immutep S.A.S /Merck Sharp & Dohme Corp. | |||||||||
| 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 | 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 Fundación Jimenez Diaz H.U. Ramón y Cajal (Madrid) H. Regional Universitario de Málaga H. Quirón (Pozuelo Alarcon) C.H. Navarra H.U. Marqués de Valdecilla (Santander) H.U. General de Valencia H.U. La Fe (Valencia) | Incyte Biosciences International Sàrl | |||||||||
| 2019-000790-23 | 4338399 | AN2025H0301 | The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | Phase III | The 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 (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. | RECLUTANDO | Buparlisib Paclitaxel | 26 Sites in Spain | Adlai Nortye Biopharma Co., Ltd. | |||||||||
| 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 (Barcelona) H.U. La Paz (Madrid) H. La Fe (Valencia) H. Virgen del Rocío (Sevilla) H. Clínico de Valencia H.U. Virgen Macarena (Sevilla) H. Regional de Málaga H.U. de Jaén H. del Mar (Barcelona) M.D. Anderson (Madrid) H.U. Vall d´Hebron (Barcelona) C.U.N. | Gilead Sciences | |||||||||
| 2021-004627-33 | 5323656 | GSN000400 | A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN | Phase II | The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab. | RECLUTANDO | Setanaxib Pembrolizumab Placebo | H. U. Cruces (Barakaldo) H.U. La Paz (Madrid) H. Clínic (Barcelona) H.U. Virgen del Rocío (Sevilla) H. La Fe (Valencia) Complejo Universitario Navarra | Calliditas Therapeutics Suisse SA | |||||||||
| 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.U. Vall d' Hebron (Barcelona) ICO Hospitalet H. Clínico San Carlos (Madrid) | Boehringer Ingelheim | |||||||||
| 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 | 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 | |||||||||
| 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 (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 | |||||||||
| 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 (Barcelona) H.U. Vall d´Hebron (Barcelona) 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 (Barcelona) H. Clínic (Barcelona) H.U. Vall d'Hebron (Barcelona) Start_F.J. Díaz (Madrid) Start_Sanchinarro (Madrid) | Hookipa Biotech GmbH | |||||||||
| 2017-000086-74 | 3088059 | EORTC-1559-HNCG | A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck | Phase II | This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts. | RECLUTANDO | Afatinib Palbociclib standard of care IPH2201 Durvalumab Niraparib INCAGN01876 | H. Clínico de Valencia H.U. 12 de Octubre (Madrid) ICO Hospitalet H.U. Vall d'Hebron (Barcelona) H. Clínico San Carlos (Madrid) H. Virgen Valme (Sevilla) | EORTC | |||||||||
Tumores Sólidos con Cohorte de Cáncer de Cabeza y Cuello | ||||||||||||||||||
| UNK | 5077709 | IOB-022/ KEYNOTE-D38 | IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or 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 | H. Clínico de Valencia H. U. Virgen Macarena (Sevilla) H.U. Virgen de la Victoria (Málaga) Fundación Jiménez Diaz (Madrid) H.U. Ramón y Cajal ICO Girona ICO Badalona H.U. Lozano Blesa (Zaragoza) H.U. Vall d´Hebron (Barcelona) H.U. 12 de Octubre (Madrid) | IO Biotech | |||||||||
| 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 (Barcelona) H.U. Ramón y Cajal (Madrid) H. Quironsalud (Barcelona) ICO Badalona H. Manresa | Seattle Genetics, 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. U. Ramón y Cajal (Madrid) H. U. Virgen del Rocío (Sevilla) H. Quiron Salud (Pozuelo de Alarcon) | Merck Sharp & Dohme LLC | |||||||||
| 2018-001608-12 | 3645928 | IOV-COM-202 | A Phase 2, 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 | 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 | |||||||||
| UNK | 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 | 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 (Barcelona) H. Quirón (Barcelona) Start_F.J. Díaz (Madrid) C.U.N. Start_Sanchinarro (Madrid) Next_Oncology (Quirón-Pozuelo) | Merus N.V. | |||||||||
| 2021-004855-18 | 5176483 | XL092-002 | 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 | Phase I | Dose-escalation followed by expansion phase with parallel assignment. | RECLUTANDO | XL092 Nivolumab Ipilimumab Nivolumab + Relatlimab | H.U. 12 de Octubre (Madrid) H.U. Virgen del Rocío (Sevilla) H. La Fe (Valencia) H.U. Clínic (Barcelona) C.U.N. | Exelixis | |||||||||
| UNK | 4989387 | INCA 0186-101 | A Phase 1, Open-Label, Multicenter Study of INCA00186 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors. | Phase I | This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN). Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy. | RECLUTANDO | INCA00186 Retifanlimab INCB106385 | ICO Hospitalet H.U. Vall d´Hebron (Barcelona) Fundación Jiménez Díaz (Madrid) H.U. 12 de Octubre (Madrid) H.U. Virgen de la Victoria (Málaga) H. Quirón (Pozuelo Alarcon) | Incyte Corporation | |||||||||
| UNK | 4442126 | NB-ND021 (NM21-1480)-101 | A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors | Phase I, first-in-human | This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 for safety and immunogenicity | RECLUTANDO | NM21-1480 | C.H.U. A Coruña H. General U. de Elche C. H. de Jaén H.U. Virgen de la Victoria (Málaga) C.U.N. H. Sanchinarro (Madrid) H. Son Llatzer (P. Mallorca) H. La Fe (Valencia) | Numab Therapeutics AG | |||||||||
| 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 | Phase I, first-in-human | Head and Neck Squamous Cell Carcinoma Renal Cell Carcinoma Melanoma Sarcoma Testicular Germ Cell Tumor Cervical Cancer Mesothelioma Non Small Cell Lung Cancer Gastric Cancer | RECLUTANDO | HFB200301 | H.U. Vall d´Hebron (Barcelona) H.U. 12 de Octubre (Madrid) H. Clínico de Valencia | 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 | (phase 1, first-in-human (FIH) and an expansion part (phase 2a)) | Solid Tumors: Squamous Cell Carcinoma of the Head and Neck Non-small Cell Lung Cancer Urothelial Carcinoma Endometrial Carcinoma Triple Negative Breast Cancer Cervical Cancer | RECLUTANDO | GEN1046 GEN1046 in combination with docetaxel (in a single expansion cohort) GEN1046 in combination with pembrolizumab (in a separate expansion cohort) | H.U. Vall d´Hebron (Barcelona) H.U. 12 de Octubre (Madrid) Start_F.J.Díaz (Madrid) Start_Sanchinarro (Madrid) Next_Oncology (Quirón-Pozuelo) H. Quirón (Barcelona) C.U.N. H.U. La Princesa (Madrid) M.D. Anderson (Madrid) H.U. Virgen de la Victoria (Málaga) H. Clínico de Valencia | Genmab | |||||||||
| 2019-000722-22 | 4069026 | 20201 | An 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 Tumors | Phase I | Dose expansion of BAY2416964 in tumor type specific: HNSCC, NSCLC, Urothelial cancer and Colorectal cancer MSS | RECLUTANDO | BAY2416964 | ICO Hospitalet H.U. 12 de Octubre (Madrid) H. Clínico de Valencia H.U. Ramón y Cajal (Madrid) | Bayer | |||||||||
| UK | 4580485 | INCB 106385-102 | A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumor. | Phase I | This 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. | RECLUTANDO | INCB106385 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 | |||||||||
| 2019-001965-34 | 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 endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer. | RECLUTANDO | Autologous genetically modified ADP-A2M4CD8 cells | H.U. 12 de Octubre (Madrid) C.U.N. H. Clínico de Valencia H.U. Vall d´Hebron (Barcelona) Start_F.J.Díaz (Madrid) Start_Sanchinarro (Madrid) H. U. Virgen del Rocío (Sevilla) | Adaptimmune | |||||||||
| 2018-004334-15 | 4234113 | SC103 | 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 Tumors | Phase I | HNSCC & 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 tumors | RECLUTANDO | SO-C101 Pembrolizumab | H.U. Vall d´Hebron (Barcelona) | SOTIO | |||||||||
| 2020-000075-20 | 4465487 | R6569-ONC-1933 | A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid, Squamous Cell Carcinoma of Head and Neck & other Tumor Malignancie. | Phase I | For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. | RECLUTANDO | REGN6569 Cemiplimab | ICO Hospitalet H.U. Vall d´Hebron (Barcelona) H.U. Ramón y Cajal (Madrid) Start_F.J.Díaz (Madrid) Start_Sanchinarro (Madrid) M.D. Anderson (Madrid) | Regeneron Pharmaceuticals | |||||||||
| 2021-006804-34 | 5383170 | CYP003/KND11 | A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST) | Phase Ib/2a | This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab. | Not yet recruiting (13/03/23) | CyPep-1 Pembrolizumab 25 MG/ML | H.U. Vall d'Hebron (Barcelona) H.U. 12 de Octubre (Madrid) Start_Sanchinarro (Madrid) C.U.N. H.U. Virgen Macarena (Sevilla) | Cytovation AS | |||||||||
| 2018-004303-40 | 3821935 | M19-345 | A 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 Tumors | Phase I | The 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. | RECLUTANDO | ABBV-151 Budigalimab | Start_Fundación Jiménez Díaz (Madrid) H.U. Clínic (Barcelona) H. Clínico de Valencia | AbbVie | |||||||||
| 2019-004748-31 | 4254107 | SGNTGT-001 | A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies | Phase I | The 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. | RECLUTANDO | SEA-TGT Sasanlimab | H.U. Vall d´Hebron (Barcelona) Start_Sanchinarro (Madrid) | Seagen Inc. | |||||||||
| 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 | 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 | ICO Badalona Start_Fundación Jiménez Díaz (Madrid) Start_Sanchinarro (Madrid) C.U.N. | Bristol-Myers Squibb | |||||||||
| 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 (Barcelona) H. Clínico de Valencia Start_Sanchinarro (Madrid) H.U. Virgen de la Victoria (Málaga) H.U. 12 de Octubre (Madrid) Start_Fundación Jiménez Díaz (Madrid) M.D. Anderson (Madrid) H.U. Virgen del Rocío (Sevilla) C.U.N. H. Clínico San Carlos (Madrid) H.U. Gregorio Marañón (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 Subjects With Malignant Solid Tumors. | Ph1, first-in-human (FIH) 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 | C.U.N. H. Quirón (Barcelona) Next_Oncology (Quirón-Pozuelo) H.U. Vall d´Hebron (Barcelona) Start_Fundación Jiménez 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 | |||||||||
| 2020-001035-27 | 4389632 | SGNB6A-001 | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors | 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 | H.U. Vall d´Hebron (Barcelona) Start_Sanchinarro (Madrid) H.U. Marqués de Valdecilla (Santander) H. M. Nou Delfos (Barcelona) | Seagen Inc. | |||||||||
| 2018-004771-12 | 4000529 | CTNO155B12101 | A 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 Malignancies | Phase Ib | Open-label study with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors to characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib and to identify the MTD and/or recommended regimen (dose and schedule) for each combination. | RECLUTANDO | TNO155 Spartalizumab Ribociclib | H.U. Vall d´Hebron (Barcelona) H. Clínico de Valencia | Novartis Pharmaceuticals | |||||||||
| 2018-001463-23 | 3212404 | CK-301-101 | A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers | Phase I | The 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-groups | RECLUTANDO | CK-301 (cosibelimab) | 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) H.U. de Canarias (La Laguna) C.U.N . | Checkpoint Therapeutics, Inc. Novotech (Australia) Pty Limited | |||||||||
| UNK | 5325866 | 20210104 | A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301) | Phase 1b/2 | The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity. Solid Tumors | RECLUTANDO | Bemarituzumab | H.U. Virgen de la Victoria (Málaga) C.H.U. de Santiago de Compostela | Amgen | |||||||||
| UNK | 4777994 | M20-431 | A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors | Phase I | Advanced Solid Tumor Cancer | RECLUTANDO | ABBV-CLS-484 Programmed Cell Death-1 (PD-1) Inhibitor Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) | Start_Sanchinarro (Madrid) | Calico Life Sciences LLC & AbbVie | |||||||||
| NA | 4717765 | RCT-LB-VE-20 | Phototherapy 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. | Phase IV | The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment. | RECLUTANDO | Device: 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 | C.H.U. de Santiago de Compostela | University of Santiago de Compostela | |||||||||
| NA | 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 (ICI) | 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 | |||||||||
| NA | 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 | Savan Research S.L | Savana Research & Head and Neck Cancer International Group (HNCIG) | |||||||||
| NA | 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. | Not yet recruiting (13/03/23) | Surgical Resection and Reconstruction | H.U. 12 de Octubre (Madrid) | AO Clinical Investigation and Publishing Documentation | |||||||||
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