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SNCTP000002038 | NCT01968109 | BASEC2016-00429

Studie zur Bewertung der Sicherheit von Anti-LAG-3 allein oder in Kombination mit Nivolumab bei der Behandlung von soliden Tumoren.

Base di dati: BASEC (Importata da 28.03.2024), WHO (Importata da 20.03.2024)
Cambiato: 27 feb 2024, 01:00
Categoria di malattie: Altro cancro

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Studie zur Beurteilung der Sicherheit und Verträglichkeit, Bestimmung von Nebenwirkungen, welche die Dosierung begrenzen, und Ermittlung der maximal verträglichen Dosis von BMS-986016 allein und in Kombination mit Nivolumab bei Patienten mit bestimmten fortgeschrittenen (mit Metastasen und/oder inoperabel) soliden Tumoren und um vorläufige Hinweise auf den klinischen Nutzen dieser Kombination zu liefern.

Malattie studiate(Fonte di dati: BASEC)

Dosiseskalation: Patienten mit anderen nicht mit immunonkologischen Wirkstoffen vorbehandelten Tumoren, einschließlich Kopf- und Nacken-, Magen-, Hepatozellulären-, Zervix-, Ovarial-, Blasen- und Kolorektalkarzinomen; Patienten mit Melanom und NSCLC in Erstlinie; Patienten mit Nierenzellkarzinom nicht mit IO; Patienten mit NSCLC, bei denen während oder nach einer Therapie mit Anti-PD-1- oder Anti-PD-L1 eine Progression auftritt; Patienten mit Melanom, bei denen während oder nach der Therapie mit Anti-CTLA-4- und/oder Anti-PD-1-/Anti-PDL-1-Antikörpern eine Progression auftritt; Dosisexpansion: Alles oben genannte mir Ausnahme von Zervix-, Ovarial-, und Kolorektalkarzinomen

Health conditions (Fonte di dati: WHO)

Neoplasms by Site

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Nivolumab, Anti-LAG-3

Interventions (Fonte di dati: WHO)

Biological: Relatlimab;Biological: Nivolumab;Biological: BMS-986213

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

Progress oder Unverträglichkeit bei mindestens einer Behandlung mit der Standardtherapie
Behandlung mit einer beliebigen Anzahl an Vortherapien
Leistungsstatus nach ECOG von 0 oder 1
Mindestens eine Läsion mit messbarer Krankheit zum Studienstart
Verfügbarkeit von bereits existierenden Tumorbiopsieproben (oder Einverständnis für eine Tumorbiopsie vor der Behandlung, falls noch keine vorhanden ist)

Criteri di esclusione (Fonte di dati: BASEC)

Primäre ZNS Tumore oder solide Tumore mit ZNS Metastasen als einziger Punkt mit Krankheitsaktivität
Autoimmunerkrankung
Enzephalitis, Meningitis, oder unkontrollierte Krampfanfälle im Jahr vor Unterzeichnung der Einverständniserklärung
Unkontrollierte ZNS Metastasen

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Gender: All
Maximum age: N/A
Minimum age: 12 Years

Inclusion Criteria:

- For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer
(CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology
agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to
IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma
subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or
without anti-CTLA-4.

- For Dose Expansion: all of the above in escalation except for cervical, ovarian, and
CRC

- Progressed, or been intolerant to, at least one standard treatment regimen, except for
participants in 1st line cohorts.

- ECOG performance status between 0 and 2

- At least 1 lesion with measurable disease at baseline

- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment
tumor biopsy)

Exclusion Criteria:

- Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the
only site of active disease

- Autoimmune disease

- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent

- Uncontrolled CNS metastases

Other protocol defined inclusion/exclusion criteria could apply

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/ct2/show/NCT01968109

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01968109
Altre informazioni sulla sperimentazione

Stato di reclutamento

Active, not recruiting

Titolo scientifico (Fonte di dati: WHO)

A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Fase (Fonte di dati: WHO)

Phase 1/Phase 2

Punti finali primari (Fonte di dati: WHO)

Proportion of participants with Adverse Events (AEs);Proportion of participants with Serious Adverse Events (SAEs);Proportion of Deaths;Proportion of participants with laboratory abnormalities in blood;Proportion of participants with laboratory abnormalities in blood serum;Proportion of participants with laboratory abnormalities in urine;Objective response rate (ORR);Disease control rate (DCR);Duration of response (DOR);Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ;Proportion of participants with AEs leading to discontinuation of treatment

Punti finali secondari (Fonte di dati: WHO)

Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab;Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab;Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab;Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab;Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab;Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab;Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab;Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab;Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab;QTc interval from centrally read electrocardiograms (ECGs);Best overall response (BOR);ORR;DCR;Duration of response (DOR);Progression-free survival (PFS) rates;Overall survival (OS);Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Losanna, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

Australia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Switzerland, United Kingdom, United States

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Prof. Dr. Reinhard Dummer
+41442552507
Reinhard.Dummer@usz.chv

Contatto per informazioni generali (Fonte di dati: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Kantonale Ethikkommission Zürich

Data di autorizzazione da parte della commissione d’etica

15.10.2021

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2016-00429

Secondary ID (Fonte di dati: WHO)

2014-002605-38
CA224-020
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