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NCT01968109 | SNCTP000002038

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

Data source: BASEC (Imported from 28.01.2020), WHO (Imported from 26.01.2020)
Changed: 14.01.2020
Disease category: Anderer Krebs

Brief description of trial (Source of data: 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.

Health conditions investigated (Source of data: 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 (Source of data: WHO)

Neoplasms by Site

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Nivolumab, Anti-LAG-3

Interventions (Source of data: WHO)

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

Criteria for participation in trial (Source of data: 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)

Exclusion criteria (Source of data: 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 (Source of data: 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 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT01968109

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

25.09.2013

Incorporation of the first participant

14.10.2013

Recruitment status

Recruiting

Academic title (Source of data: 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

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

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

Phase (Source of data: WHO)

Phase 1/Phase 2

Primary end point (Source of data: WHO)

Proportion of subjects with AEs leading to discontinuation of treatment;Proportion of participants with AEs meeting acute safety criteria;Duration of response (DOR);Disease control rate (DCR);Objective response rate (ORR);Proportion of subjects with laboratory abnormalities;Proportion of Deaths;Proportion of subjects with Serious Adverse Events (SAEs);Proportion of subjects with Adverse Events (AEs)

Secundary end point (Source of data: 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 subjects) and nivolumab;QTc interval from centrally read electrocardiograms (ECGs);Best overall response (BOR);ORR;DCR;Duration of response (DOR);Progression-free survival (PFS);Overall survival (OS)

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Lausanne, Zürich

Countries (Source of data: WHO)

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

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

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

Contact for general information (Source of data: 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
Clinical.Trials@bms.com

Contact for scientific information (Source of data: 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
Clinical.Trials@bms.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Bristol-Myers Squibb

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2016-00429

Secondary ID (Source of data: WHO)

2014-002605-38;CA224-020