E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Cancers |
Cánceres avanzados |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced Cancers |
Cánceres avanzados |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065252 |
E.1.2 | Term | Solid tumor |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the safety, tolerability, and DLTs, and to determine the RP2D of BMS-986253 administered in combination with nivolumab in participants with advanced solid tumors. |
Caracterizar la seguridad, tolerabilidad y TLD, y determinar la DRF2 de BMS-986253 administrado en combinación con nivolumab en participantes con tumores sólidos avanzados. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the preliminary efficacy of BMS-986253 in combination with nivolumab in participants with advanced solid tumors using RECIST v1.1.
To characterize the PK and immunogenicity of BMS-986253 when administered in combination with nivolumab in participants with advanced solid tumors.
To assess serum IL-8 levels at baseline (ie,screening) and changes in IL-8 levels on-treatment. |
Evaluar la eficacia preliminar de BMS-986253 en combinación con nivolumab en pacientes con tumores sólidos avanzados usando RECIST v1.1. Caracterizar la FC y la inmunogenicidad de BMS-986253 cuando se administra en combinación con nivolumab en pacientes con tumores sólidos avanzados. Evaluar los niveles séricos de IL-8 en el momento basal (es decir, la selección) y las variaciones en los niveles de IL-8 durante el tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 - At least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 |
-Confirmación histológica o citológica de un tumor sólido que está avanzado (metastásico, recurrente y / o no resecable) con enfermedad medible por RECIST v1.1. - Al menos 1 lesión accesible para biopsia. - Puntuación de 0 a 1 del Eastern Cooperative Oncology Group (ECOG). |
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E.4 | Principal exclusion criteria |
- Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) - Participants with active, known or suspected autoimmune disease - Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration - Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy |
-Participantes con tumores primarios del sistema nervioso central (SNC) o con metástasis del SNC como único foco de enfermedad activa ( sin embargo, participantes con metástasis cerebrales controladas podrán ser reclutados) - Participantes con enfermedad autoinmune activa, conocida o sospechada - Participantes con afecciones que requieren tratamiento sistémico con corticosteroides (> 10 mg equivalentes de prednisona) u otros medicamentos inmunosupresores dentro de los 14 días posteriores a la administración del tratamiento del estudio - Participantes con un historial conocido de pruebas positivas para el Virus de la Inmunodeficiencia Humana (VIH) o el conocido Síndrome de Inmunodeficiencia Adquirida (SIDA) - Agentes citotóxicos, a menos que hayan transcurrido al menos 4 semanas desde la última dosis de terapia anticancerígena previa e inicio de la terapia del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of adverse events (AE) Incidence of serious adverse events (SAE) Incidence of AEs meeting protocol defined dose limiting toxicities (DLT) criteria Incidence of AEs leading to discontinuation Incidence of deaths Incidence of laboratory abnormalities |
Incidencia de acontecimientos adversos (AA) Incidencia de acontecimientos adverso graves (AAG) Incidencia de AAs que cumplen con los criterios de toxicidad limitantes de la dosis (TLD) definidos en el protocolo Incidencia de AAs que conducen a una discontinuación Incidencia de muertes Incidencia de anomalías de laboratorio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 5 years |
Aproximadamente 5 años |
|
E.5.2 | Secondary end point(s) |
Overall response rate (ORR) Median duration of response (mDOR) Incidence of anti-drug antibody (ADA) to BMS-986253 Serum biomarker concentration Maximum observed serum concentration (Cmax) Time of maximum observed serum concentration (Tmax) Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Observed serum concentration at the end of a dosing interval (Ctau) Trough observed serum concentration at the end of the dosing interval (Ctrough) |
Tasa de respuesta global (TRG) Mediana de la duración de la respuesta (mDdR) Incidencia de anticuerpo anti-fármaco (AAF) para BMS-986253 Concentración sérica de biomarcador Concentración sérica máxima observada ( Cmax) Tiempo de concentración sérica máxima observada (Tmax) Área bajo la curva de concentración sérica-tiempo desde tiempo cero hasta el tiempo dela última concentración cuantificable [AUC(0-T)] Área bajo la curva de concentración sérica-tiempo en el intervalo de una dosis [AUC(TAU)] Concentración sérica observada al final de un intervalo de dosis (Ctau) “Trough” Concentración sérica observada al final de un intervalo de dosis (Ctrough) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 5 years |
Aproximadamente 5 años |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Phase Ib - safety evaluation lead-in period |
Fase Ib- período de introducción de evaluación de seguridad |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Finland |
Germany |
Norway |
Spain |
Sweden |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |