Portal de investigación
Primer ensayo en seres humanos, fase 1/2 de BMS-986288 en monoterapia y en combinación con nivolumab en tumores malignos avanzados.
Datos básicos
- Protocolo:
- CA043-001
- EUDRACT:
- 2021-004284-27
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
- 2024
Objetivos del proyecto
Objetivo Principal: Caracterizar la seguridad, la tolerabilidad y las toxicidades limitadas por la dosis (TLD) y determinar la dosis máxima tolerada (DMT) /dosis recomendada de fase 2(DRF2) de BMS-986288 administrado en monoterapia y en combinación con nivolumab en participantes con tumores sólidos avanzados seleccionados Objetivos Secundarios: -Caracterizar la farmacocinética (FC) de BMS-986288 administrado en monoterapia y en combinación con nivolumab -Evaluar la eficacia preliminar de BMS-986288 en monoterapia y en combinación con nivolumab en tumores sólidos avanzados usando los criterios RECIST v1.1 -Medir los linfocitos T reguladores (Treg) y evaluar el cambio de Treg a lo largo del tiempo y en asociación con la respuesta
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
López DF; (...); Ortiz-Romero, P. L.
Article. 10.1016/j.ad.2022.11.013. 2023
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A Randomized, Open-Label Phase II Study Evaluating Emibetuzumab Plus Erlotinib and Emibetuzumab Monotherapy in MET Immunohistochemistry Positive NSCLC Patients with Acquired Resistance to Erlotinib.
Camidge DR; (...); Smit E
Article. 10.1016/j.cllc.2022.03.003. 2022
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.
Passaro, A; (...); Cho, B C
Article. 10.1016/j.annonc.2023.10.117. 2024
Amyloid brain-dedicated PET images can diagnose Alzheimer's pathology with Centiloid Scale.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1016/j.ejmp.2024.103345. 2024
An open-label, multicenter, phase 2 study of the safety and efficacy of navtemadlin (KRT-232) in patients with TP53 wild-type relapsed/refractory small cell lung cancer.
Dowlati, Afshin; (...); Carpeno, Javier de Castro
Meeting Abstract. 2022
Artificial Intelligence on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.
Prats-Climent, Joan; (...); Marti-Bonmati, Luis
Article. 10.1007/s10916-022-01836-w. 2022
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC.
Andric, Zoran; (...); Ciardiello, Fortunato
Article. 10.1016/j.jtocrr.2022.100461. 2023
Capmatinib vs docetaxel as second- or third-line (2/3L) therapy in patients (pts) with METex14-mutated advanced NSCLC (aNSCLC): The GeoMETry-III trial
Vidal, O. J. Juan; (...); Wolf, J.
Meeting Abstract. 10.1016/j.annonc.2023.09.2424. 2023
Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients
Espallardo, I. Torres; (...); Prado-Wohlwend, S.
Meeting Abstract. 2023
ComBat harmonization in different PET imaging scenarios
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2023
Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.
Martinez-Movilla, Andrea; (...); Carles, Montserrat
Article. 10.1186/s40658-022-00509-4. 2022
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
Correction to: SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
García-Campelo R; (...); Dómine M
Correction. 10.1007/s12094-023-03290-7. 2023
Current treatment landscape for oligometastatic non-small cell lung cancer
Garde-Noguera, Javier; (...); Counago, Felipe
Article. 10.5306/wjco.v13.i6.485. 2022
Characterization of patients with advanced non-small-cell lung cancer (NSCLC) harboring KRASG12C mutation and their associated direct healthcare costs in Spanish routine clinical practice (SILK study)
Aransay, N. Reguart; (...); Vila, A. Lloansi
Meeting Abstract. 10.1016/j.annonc.2023.09.2442. 2023
Determination of essential biomarkers in lung cancer: A real-world data study in Spain
Calvo de Juan, V.; (...); Provencio Pulla, M.
Meeting Abstract. 10.1016/j.annonc.2022.02.048. 2022
Determination of essential biomarkers in lung cancer: a real-world data study in Spain with demographic, clinical, epidemiological and pathological characteristics
Provencio, Mariano; (...); Torrente, Maria
Article. 10.1186/s12885-022-09830-8. 2022
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Development of a predictive model for early detection of lung cancer: SREAL-eLUNG study
Vidal, O. J. Juan; (...); Martinez, B. Valdivieso
Meeting Abstract. 2023
Development of severity and mortality prediction models for covid-19 patients at emergency department including the chest x-ray.
Calvillo-Batllés P; (...); Martí-Bonmatí L
Article. 10.1016/j.rxeng.2021.09.004. 2022
Durvalumab (D) plus tremelimumab (T) in platinum-refractory/resistant extensive-stage small cell lung cancer (ES-SCLC): Efficacy, safety and ctDNA dynamics from Arm A of the phase 2 BALTIC study
Reinmuth, Niels; (...); Bondarenko, Igor
Meeting Abstract. 2022
ECONOMIC BURDEN OF ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) PATIENTS HARBORING KRASG12C MUTATION IN SPAIN
Fernandez-Barcelo, C.; (...); Sampietro-Colom, L.
Meeting Abstract. 2023
European Society of Medical Oncology (ESMO) guidelines for oncogene-addicted metastatic non-small cell lung cancer (NSCLC): a personalized treatment for each patient.
Suay, Guillermo, Aparisi, Francisco, Juan-Vidal, Oscar
Article. 10.21037/cco-23-100. 2024
FAMetA: a mass isotopologue-based tool for the comprehensive analysis of fatty acid metabolism.
Alcoriza-Balaguer MI; (...); Lahoz A
Article. 10.1093/bib/bbad064. 2023
First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS)
Carbone, David Paul; (...); Reck, Martin
Meeting Abstract. 2023
First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS).
Carbone, David Paul; (...); Reck, Martin
Meeting Abstract. 10.1200/JCO.2023.41.17_suppl.LBA9023. 2023
First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.
Ready, Neal E.; (...); Paz-Ares, Luis
Article. 10.1136/jitc-2022-006127. 2023
First-Line Nivolumab Plus Ipilimumab With Chemotherapy Versus Chemotherapy Alone for Metastatic NSCLC in CheckMate 9LA: 3-Year Clinical Update and Outcomes in Patients With Brain Metastases or Select Somatic Mutations
Paz-Ares, Luis G.; (...); Carbone, David P.
Article. 10.1016/j.jtho.2022.10.014. 2023
First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes.
Reck, Martin; (...); Carbone, David P.
Article. 10.1016/j.ejca.2023.01.015. 2023
Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.
Carbone DP; (...); Reck M
Article. 10.1136/jitc-2023-008189. 2024
Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.
Saborido-Moral, Juan D.; (...); Carles, Montserrat
Article. 10.1016/j.ejmp.2023.103153. 2023
GALLANT-1: Galectin-3 (Gal-3) inhibitor GB1211 plus atezolizumab (atezo) in patients with non-small cell lung cancer (NSCLC)-A randomized, double-blind trial.
Ghiringhelli, Francois; (...); Basse, Linda
Meeting Abstract. 2022
GALLANT-1: GB1211 galectin-3 (Gal-3) inhibitor plus atezolizumab (atz) for first line treatment in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC)
Aparisi Aparisi, F. D. A.; (...); Ghiringhelli, F.
Meeting Abstract. 10.1016/j.annonc.2023.09.2491. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Genotypic Characteristics and Resistance Mutations in Advanced ALK plus NSCLC: The ALK-PATHFINDER Study
Lopez Castro, R.; (...); Ponce Aix, S.
Meeting Abstract. 2023
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Cerda Alberich, Leonor; (...); Marti-Bonmati, Luis
Editorial Material. 10.1007/978-1-0716-1712-0_20. 2022
Immunogenicity of COVID-19 vaccines in lung cancer patients.
Provencio M; (...); Calvo V
Article. 10.1016/j.lungcan.2023.107323. 2023
Impact of Molecular Testing Using Next-Generation Sequencing in the Clinical Management of Patients with Non-Small Cell Lung Cancer in a Public Healthcare Hospital.
Simarro, Javier; (...); Palanca, Sarai
Article. 10.3390/cancers15061705. 2023
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Labyrinthine Bifurcation of the Facial Nerve
Saro-Buendia, Miguel; (...); Carceller, Miguel Armengot
Article. 10.1007/s12070-023-03977-x. 2023
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Medical imaging clinical trials unit: A professional need.
Penades-Blasco, Ana; (...); Marti-Bonmati, Luis
Article. 10.1016/j.ejrad.2021.110099. 2022
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases
Nadal, E.; (...); Bruna, J.
Meeting Abstract. 2022
Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1007/s10916-023-01984-7. 2023
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05).
Nadal E; (...); Bruna J
Article. 10.1200/JCO.22.02561. 2023
Posterior Lingual Abscess; Report of Two Cases.
Saro-Buendia, Miguel; (...); Armengot Carceller, Miguel
Case Reports. 10.22037/aaem.v11i1.1860. 2023
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
Falkenhain-Lopez, D; (...); Ortiz-Romero, P L
Article. 10.1016/j.ad.2022.11.010. 2023
Quantitative evaluation of a non-CT based attenuation correction method for a new dedicated brain PET
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2022
Radioembolization in patients with hepatocellular carcinoma: a series of 53 cases.
Olivan-Sasot, P; (...); Olivas-Arroyo, C
Article. 10.1016/j.rxeng.2021.03.001. 2023
Real-world outcomes of first-line pembrolizumab (Pem) for metastatic non-small cell lung cancer (mNSCLC) with >= 50% expression of programmed cell death-ligand 1 (PD-L1): A multicentre retrospective study
Perea, J.; (...); Gaudens, P. Capdevila
Meeting Abstract. 2023
Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.
Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis
Article. 10.1016/j.bbr.2023.114844. 2024
RET Fusion Testing in Patients With NSCLC: The RETING Study.
Conde, Esther; (...); Lopez-Rios, Fernando
Article. 10.1016/j.jtocrr.2024.100653. 2024
RET Fusion Testing with FISH and Real-Time PCR: a Comparison with RNA-Based Next-Generation Sequencing in RET Positive NSCLC
Hernandez, S.; (...); Conde, E.
Meeting Abstract. 2022
Second-line treatment in advanced non-squamous (NS) non-small cell lung cancer (NSCLC) patients in Spain, analyzed in the Thoracic Tumor Registry (RTT)
Carcereny Costa, E.; (...); Provencio Pulla, M.
Meeting Abstract. 10.1016/j.annonc.2022.02.062. 2022
SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
Garcia-Campelo, Rosario; (...); Domine, Manuel
Article. 10.1007/s12094-023-03216-3. 2023
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 2023
Sex differences in the diagnosis, treatment and prognosis of cancer: the rationale for an individualised approach.
Vera, Ruth; (...); del Alba, Aranzazu Gonzalez
Article. 10.1007/s12094-023-03112-w. 2023
Sex Differences in the Efficacy of Immune Checkpoint Inhibitors in Neoadjuvant Therapy of Non-Small Cell Lung Cancer: A Meta-Analysis
Suay, Guillermo; (...); Juan-Vidal, Oscar
Review. 10.3390/cancers15184433. 2023
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Spatially Preserved Multi-Region Transcriptomic Subtyping and Biomarkers of Chemoimmunotherapy Outcome in Extensive-Stage Small Cell Lung Cancer.
Peressini M; (...); Zugazagoitia J
Article. 10.1158/1078-0432.CCR-24-0104. 2024
Survival outcomes in ALK-positive NSCLC patients (p) treated 1st line brigatinib and impact of the ALK fusion variant
Provencio-Pulla, Mariano; (...); Romero, Atocha
Meeting Abstract. 2023
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer.
Ahn MJ; (...); Paz-Ares L
Article. 10.1056/NEJMoa2307980. 2023
Technical Validation and Clinical Implications of Ultrasensitive PCR Approaches for EGFR-Thr790Met Mutation Detection in Pretreatment FFPE Samples and in Liquid Biopsies from Non-Small Cell Lung Cancer Patients
Simarro, Javier; (...); Palanca, Sarai
Article. 10.3390/ijms23158526. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.
Gomez Rueda, Ana; (...); Garrido, Pilar
Article. 10.1007/s12094-024-03404-9. 2024
Translation of a tissue epigenetic signature to circulating free DNA suggests BCAT1 as a potential noninvasive diagnostic biomarker for lung cancer
Palanca-Ballester, Cora; (...); Sandoval, Juan
Article. 10.1186/s13148-022-01334-3. 2022
Updated analysis from the ATEZO-BRAIN trial: Atezolizumab plus carboplatin and pemetrexed in patients with advanced nonsquamous non-small cell lung cancer with untreated brain metastases.
Nadal, Ernest; (...); Bruna, Jordi
Meeting Abstract. 2022
Utility of Next-Generation Sequencing in the Reconstruction of Clonal Architecture in a Patient with an EGFR Mutated Advanced Non-Small Cell Lung Cancer: A Case Report.
Simarro J; (...); Palanca S
Article. 10.3390/diagnostics12051266. 2022
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023