E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive-Stage Small Cell Lung Cancer |
Carcinoma microcítico de pulmón en estadio extendido |
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E.1.1.1 | Medical condition in easily understood language |
Extensive-Stage Small Cell Lung Cancer |
Carcinoma microcítico de pulmón en estadio extendido |
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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 of rovalpituzumab tesirine when administered in combination with nivolumab or nivolumab and ipilimumab in adult subjects with extensive-stage small cell lung cancer (SCLC) |
Evaluar la seguridad de rovalpituzumab tesirina cuando se administra en combinación con nivolumab o nivolumab e ipilimumab en sujetos adultos con carcinoma microcítico de pulmón (CMP) en estadio extendido |
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E.2.2 | Secondary objectives of the trial |
To explore the efficacy of rovalpituzumab tesirine when administered in combination with nivolumab or nivolumab and ipilimumab in adult subjects with extensive-stage SCLC |
Estudiar la eficacia de rovalpituzumab tesirina cuando se administra en combinación con nivolumab o nivolumab e ipilimumab en sujetos adultos con CMP en estadio extendido |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Minimum of 18 years old - Participants with histologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease - Eastern Cooperative Oncology Group (ECOG) 0-1 - Adequate hematologic, hepatic, and renal function |
- Adulto de 18 años de edad o más. - CMP en estadio extendido confirmado mediante histología o citología con PE después de al menos un régimen quimioterapéutico basado en platino. - Estado funcional ECOG de 0 o 1. - Función hematológica, hepática y renal adecuada |
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E.4 | Principal exclusion criteria |
- Has active, known, or suspected autoimmune disease - Had prior exposure to an immuno-oncology or pyrrolobenzodiazapine (PBD)-based drug |
- Enfermedad autoinmunitaria activa, conocida o presunta. - Tratamiento previo con o exposición a un fármaco basado en pirrolobenzodiazepina (PBD) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints - analysis of the safety endpoints will include the following measurements or assessments: Adverse events (Aes) and dose-limiting toxicities (DLTs), vital signs, body weight, laboratory abnormalities, electrocardiographic parameters, echocardiography, Eastern Cooperative Oncology Group (ECOG) performance status, monitoring of concomitant medications. Efficacy Endpoints - response assessments as per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, including ORR and CBR, Duration of Response (DOR), Progression-free survival (PFS), PFS status after 6 months from the initiation of study treatment, OS. Radiographic imaging, pharmacokinetics, biomarker, and pharmacodynamic endpoints - Specific PK parameters of all drugs, ATA incidence and timing, Tumor DLL3 and PD-L1 expression, inflammatory markers, blood tumor markers, immune markers, biomarkers, including soluble DLL3, circulating tumor cells (CTCs) |
Criterios de valoración de seguridad: el análisis de los criterios de valoración de seguridad incluirá las siguientes medidas o evaluaciones: Eventos adversos (Aes) y toxicidad limitante de la dosis (DLT), signos vitales, peso corporal, anomalías de laboratorio, parámetros electrocardiográficos, ecocardiografía, Eastern Cooperative Oncology Group ), monitoreo de los medicamentos concomitantes. Criterios de valoración de la respuesta en tumores sólidos (RECIST) v 1.1, incluyendo ORR y CBR, duración de la respuesta (DOR), supervivencia libre de progresión (PFS), estado de PFS después de 6 meses desde el inicio del tratamiento del estudio , OS. Los parámetros de PK específicos de todos los fármacos, la incidencia y el momento de ATA, la expresión de los tumores DLL3 y PD-L1, los marcadores inflamatorios, los marcadores de tumores sanguíneos, los marcadores inmunológicos, los biomarcadores, incluyendo DLL3 soluble, las células tumorales circulantes (CTCs) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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 | No |
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 |
To assess the safety of Rova-T administered in combo with nivolumab, or nivolumab and ipilimumab. |
Evaluar la seguridad de Rova-T administrado en combo con nivolumab, o nivolumab e ipilimumab. |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
France |
Germany |
Italy |
Spain |
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
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Treatment will continue for all subjects until they withdraw consent, experience an AE that warrants them coming off study, death, investigator decision, they become lost to follow-up, they have significant protocol non-compliance, the study is terminated by the sponsor. Since nivolumab may be given indefinitely, the study will continue until the last subject undergoing treatment has experienced one of the above. |
El tratamiento continuará para todos los sujetos hasta que retiren su consentimiento, experimenten una AE que les garantice salir del estudio, la muerte, la decisión del investigador, se pierden en el seguimiento, tienen incumplimiento significativo del protocolo, el estudio es terminado por el patrocinador. Dado que el nivolumab se puede administrar indefinidamente, el estudio continuará hasta que el último sujeto sometido a tratamiento haya experimentado uno de los anteriores. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |