Uno studio per valutare la sicurezza, la tollerabilità, la farmacocinetica e l'efficacia preliminare di BMS-986489 nei partecipanti cinesi con carcinoma polmonare recidivante/refrattario
Uno studio di etichetta aperta, a braccio singolo, multicentrico, di fase 1 per valutare la sicurezza, la tollerabilità, la farmacocinetica e l'efficacia preliminare di BMS-986489 (BMS-986012 + Nivolumab a dose fissa) nei partecipanti cinesi con recidivati/referi Cancro
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Shanghai, Cina, 200120
- Local Institution - 0002
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100142
- Local Institution - 0004
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Shandong
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Jinan, Shandong, Cina, 250117
- Local Institution - 0003
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Linyi, Shandong, Cina, 276001
- Local Institution - 0001
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310016
- Local Institution - 0005
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
i) For initial limited stage (LS) SCLC:.
A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- Participants must have a life expectancy of ≥12 weeks.
- Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
- Untreated symptomatic CNS metastases.
- Leptomeningeal disease.
- Pleural effusion which cannot be controlled with appropriate interventions.
- Malignancy-related superior vena cava syndrome.
- Participants with an active, known or suspected, autoimmune disease.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- Unresolved toxicity from prior anti-tumor therapy.
- Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
- Other protocol-defined inclusion/exclusion criteria apply.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: BMS-986489
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Specified dose on specified days |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Number of participants with adverse events (AEs)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with Serious AEs (SAEs)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
|
Number of participants with AEs leading to discontinuation of study treatment
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with select AEs
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with immune-mediated AEs (IMAEs)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of deaths
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with laboratory abnormalities
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Maximum observed concentration (Cmax) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Time of maximum observed concentration (Tmax) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Trough observed plasma concentration (Ctrough) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Concentration at the end of a dosing interval (Ctau) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
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Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
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Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Total body clearance (CLT) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Observed concentration at end of infusion (Ceoi) for BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with ADAs to nivolumab
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ctrough for nivolumab
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ceoi for nivolumab
Lasso di tempo: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Overall Response (OR)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Disease Control (DC)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Duration of Response (DOR)
Lasso di tempo: Up to 19 months after last participant's first treatment
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Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. |
Up to 19 months after last participant's first treatment
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Bristol-Myers Squibb, Bristol-Myers Squibb
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CA245-0002
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Periodo di condivisione IPD
See Plan Description
Criteri di accesso alla condivisione IPD
See Plan Description
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .