E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male and female participants ≥ 18 years of age with advanced or metastatic cancers . |
Participantes varones y mujeres ≥ 18 años con cánceres avanzados o metastásicos. |
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E.1.1.1 | Medical condition in easily understood language |
Advanced or metastatic cancers of the following types: NSCLC, SCCHN, MSS-CRC, gastric/GE junction adenocarcinoma, or cervical cancer (SCC or adenocarcinoma). |
Cánceres avanzados o metastásicos de los siguientes tipos: CPNM, CCECC, CRC-MSS, adenocarcinoma gástrico/de la unión GE o cáncer del cuello uterino (CCE o adenocarcinoma). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 assess the safety, tolerability, and to determine the MTD, MAD, and/or RP2D(s) of BMS-986340 administered as monotherapy and in combination with nivolumab |
Evaluar la seguridad, la tolerabilidad y determinar la DMT, la DMA y/o la(s) DRF2 de BMS-986340 administrada como monoterapia y en combinación con nivolumab |
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E.2.2 | Secondary objectives of the trial |
- To characterize the PK profile of BMS-986340 administered as monotherapy and in combination with nivolumab - To characterize the immunogenicity of BMS-986340 administered as monotherapy and in combination with nivolumab - To assess the preliminary anti-tumor activity of BMS-986340 as monotherapy and in combination with nivolumab |
- caracterizar el perfil FC de BMS-986340 administrado en monoterapia y en combinación con nivolumab - caracterizar la inmunogenicidad de BMS-986340 administrado en monoterapia y en combinación con nivolumab - evaluar la actividad antitumoral preliminar de BMS-986340 en monoterapia y en combinación con nivolumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy • Eastern Cooperative Oncology Group Performance Status of 0 or 1 • Radiographically documented progressive disease on or after the most recent therapy • Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated • Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant Other protocol-defined inclusion criteria apply |
• Debe proporcionarse biopsia reciente antes del tratamiento o durante el tratamiento del tumor para el análisis de biomarcadores • Enfermedad medible por Criterios de Evaluación de Respuesta en Tumores Sólidos (RECIST) v1.1 y al menos 1 lesión accesible por biopsia • Eastern Cooperative Oncology Group Performance Status de 0 or 1 • Enfermedad progresiva documentada radiográficamente durante o después del tratamiento más reciente • Se deben haber recibido terapias estándar de referencia, incluyendo un inhibidor del ligando-1 de muerte programada que haya demostrado efectividad frente al tipo de tumor que se está evaluando • Partes 1A, 1B, y 2A: Sujetos con cáncer avanzado o metastásico de pulmón no microcítico (CPNM), carcinoma de células escamosas de cabeza y cuello (CCECC), cáncer colorrectal con microsatélites estables (CRC-MSS), adenocarcinoma gástrico/de la unión gastroesofágica (GE), o cáncer de cuello uterino, que hayan recibido, sean refractarios, no sean candidatos, o sean intolerantes a las terapias existentes que hayan demostrados beneficio clínico para la condición del sujeto participante.
Otros criterios de inclusión definidos en el protocolo |
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E.4 | Principal exclusion criteria |
• Women who are pregnant or breastfeeding • Primary central nervous system (CNS) malignancy • Untreated CNS metastases • Leptomeningeal metastases • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment • Active, known, or suspected autoimmune disease • Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment • Prior organ or tissue allograft • Uncontrolled or significant cardiovascular disease • Major surgery within 4 weeks of study drug administration • History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply |
• Mujeres embarazadas o en periodo de lactancia • Neoplasia primaris del Sistema Nervioso Central (SNC) • Metástasis no tratadas del SNC • Metástasis leptomeningeas • Neoplasia simultánea que requiera tratamiento, o historial de neoplasia previa activa durante 2 años antes de la primera dosis del fármaco de estudio • Enfermedad autoinmune activa, conocida o sospechada • Condiciones clínicas que requiera tratamiento sistémico con corticosteriorides en los 14 días anteriores a la primera dosis del fármaco de estudio, o con otros farmacos inmunosupresores en los 30 días anteriores a la primera dosis del fármaco de estudio • Trasplante alogénico previo de órganos o tejidos • Enfermedad cardiovascular no controlada o significativa • Cirugía mayor en las 4 semanas previas a la administración del fármaco de estudio • Historial de enfermedad pulmonar intersticial (EPI) o EPI activa o fibrosis pulmonar
Otros criterios de exclusión definidos en el protocolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities |
Incidencia de AA, AAG, AA que cumplan los criterios de TLD definidos en el protocolo, AA que conduzcan a la discontinuación y a la muerte y anomalías de laboratorio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
continuously |
de forma continua |
|
E.5.2 | Secondary end point(s) |
1) Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab 2) Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab 3) ORR, DCR, DOR, and PFSR |
1) Conjunto de medidas de parámetros FC de BMS-986340 administrado en monoterapia y en combinación con nivolumab 2) Incidencia de anticuerpos anti-fármaco frente a BMS-986340 cuando BMS-986340 se administra como monoterapia y en combinación con nivolumab 3) TRO, TCE, DdR y TSLP |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) depends on the cycles 2) continuously 3) at 6 months and 1 year per RECIST v1.1 by investigator |
1) en función a los ciclos 2) de forma continua 3) a los 6 meses y 1 año según los RECIST v1.1 por el investigador |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Asignación secuencial |
Sequential Assignment |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
United States |
Germany |
Italy |
Spain |
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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
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Last visit or scheduled procedure shown in the Schedule of Activities of the protocol for the last participant. |
Útima visita o último procedimiento programado del último paciente, tal como se muestra en el Esquema de Actividades del protocolo |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 24 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 28 |