Einleitung wieder einblenden
NCT01968109 | SNCTP000002038

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

Datenbasis: BASEC (Import vom 24.10.2017), WHO (Import vom 22.10.2017)
Geändert: 22.10.2017

Zusammenfassende Beschreibung der Studie (Datenquelle: 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.

Untersuchte Krankheiten (Datenquelle: 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-, Blasen- und Kolorektalkarzinomen

Health conditions (Datenquelle: WHO)

Neoplasms by Site;Neoplasms by Site

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Nivolumab, Anti-LAG-3

Interventions (Datenquelle: WHO)

Biological: Relatlimab;Biological: BMS-936558;Biological: Relatlimab;Biological: BMS-936558

Kriterien zur Teilnahme an der Studie (Datenquelle: 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)

Ausschlusskriterien (Datenquelle: 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 (Datenquelle: WHO)


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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
subjects in 1st line cohorts.

- ECOG performance status of 0 or 1

- 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
;
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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
subjects in 1st line cohorts.

- ECOG performance status of 0 or 1

- 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

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT01968109

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01968109

Weitere Informationen zur Studie

Registrationsdatum der Studie

25.09.2013

Einschluss der ersten teilnehmenden Person

14.10.2013

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: 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

Studientyp (Datenquelle: WHO)

Interventional

Phase (Datenquelle: WHO)

Phase 1/Phase 2

Primäre Endpunkte (Datenquelle: WHO)

Proportion of subjects with Adverse Events (AEs);Proportion of subjects with Serious Adverse Events (SAEs);Proportion of Deaths;Proportion of subjects with laboratory abnormalities;Objective response rate (ORR);Disease control rate (DCR);Proportion of subjects with Adverse Events (AEs);Proportion of subjects with Serious Adverse Events (SAEs);Proportion of Deaths;Proportion of subjects with laboratory abnormalities;Objective response rate (ORR);Disease control rate (DCR)

Sekundäre Endpunkte (Datenquelle: WHO)

Best overall response (BOR);ORR;DCR;Duration of response (DOR);Progression-free survival (PFS);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;Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) 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 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;Efficacy as measured by tumor assessment (RECIST);Immunogenicity measured by ADA for BMS-986016 (all subjects) and nivolumab;QTc interval from centrally read electrocardiograms (ECGs)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Lausanne, Zürich

Durchführungsländer (Datenquelle: WHO)

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

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

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

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:;Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Bristol-Myers Squibb;;Bristol-Myers Squibb;
;Clinical.Trials@bms.com;;Clinical.Trials@bms.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:;Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Bristol-Myers Squibb;;Bristol-Myers Squibb;
;Clinical.Trials@bms.com;;Clinical.Trials@bms.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Bristol-Myers Squibb

Weitere Studienidentifikationsnummern

BASEC ID (Datenquelle: BASEC)

2016-00429

Secondary ID (Datenquelle: WHO)

2014-002605-38;CA224-020